Ocular Therapeutix, Inc. (OCUL) 2026 Q3 法說會逐字稿

Good morning, and welcome to the Ocular Therapeutix third quarter 2026 earnings conference call. (Operator Instructions) As a reminder, this conference call is being recorded and will be available for replay on the investor relations section of the Ocular Therapeutix website. I would now like to turn the call over to Ocular's Vice President of Investor Relations, Bill Slattery Jr. Please go ahead, Mr. Slattery.

早安，歡迎參加 Ocular Therapeutix 2026 年第三季財報電話會議。(接線員指示) 提醒各位，本次電話會議將被錄音，並可於 Ocular Therapeutix 官網投資人關係專區回放收聽。現在我想把電話交給 Ocular 投資人關係副總裁 Bill Slattery Jr. Slattery 先生，請開始。

Good morning, everyone, and thank you for joining us today. Earlier this morning, we issued a press release and filed our quarterly report on Form 10-Q, outlining our financial results and business updates for the third quarter of 2026.

各位早安，感謝今天加入我們。今天稍早，我們發布新聞稿並提交了 10-Q 季度報告，概述我們 2026 年第三季的財務結果與業務更新。

We will begin today's call with prepared remarks summarizing recent business highlights from Dr. Pravin Dugel, Ocular's Executive Chairman, President, and CEO; Dr. Nadia Waheed, Ocular's Chief Medical Officer; and David Robinson, Ocular's Global Chief Commercial Officer. Donald Notman, Ocular's Chief Operating Officer, will join for the question-and-answer session.

今天的電話會議將先由預先準備的發言開始，內容將由 Ocular 執行董事長、總裁兼執行長 Pravin Dugel 醫師；Ocular 首席醫療長 Nadia Waheed 醫師；以及 Ocular 全球首席商務長 David Robinson，總結近期業務重點。Ocular 營運長 Donald Notman 將加入問答環節。

We refer everyone to this morning's press release and our Form 10-Q for a comprehensive update of third quarter 2026 financial and business results. During today's call, certain statements we will be making constitute forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

我們請各位參考今天早上的新聞稿與我們的 10-Q，以取得 2026 年第三季財務與業務成果的完整更新。在今天的電話會議中，我們將發表的部分陳述構成《1995 年私人證券訴訟改革法案》安全港條款下的前瞻性陳述。

Actual results may differ materially as a result of a variety of factors, including risks and uncertainties identified in the risk factors section of our annual report on Form 10-K and our other SEC filings. On today's call, we will discuss our investigational product candidate, AXPAXLI, also known as OTX-TKI, which is in development for wet age-related macular degeneration and non-proliferative diabetic retinopathy. As a reminder, the safety and efficacy of AXPAXLI have not been established by the FDA or any other regulatory authority, and AXPAXLI has not been approved for marketing.

由於多種因素，實際結果可能出現重大差異，包括我們 10-K 年報風險因素章節及其他向 SEC 提交文件中所識別的風險與不確定性。今天的電話會議中，我們將討論我們的研究中產品候選藥物 AXPAXLI（亦稱 OTX-TKI），目前正開發用於濕性年齡相關性黃斑部病變（wet AMD）與非增殖性糖尿病視網膜病變。提醒各位，AXPAXLI 的安全性與有效性尚未獲 FDA 或任何其他監管機構確立，且 AXPAXLI 尚未獲准上市銷售。

With that, I'd like to hand the call over to Dr. Pravin Dugel to review our recent updates. Pravin.

接下來，我想把電話交給 Pravin Dugel 醫師，請他回顧我們近期的更新。Pravin。

Thanks, Bill, and good morning, everyone. 2026 has been an extraordinary and truly transformational year for Ocular Therapeutix. We've achieved landmark Phase 3 superiority results in SOL-1, established a clear regulatory path forward toward our first potential approval for AXPAXLI in wet AMD, and continue to generate compelling clinical evidence showing AXPAXLI's durability and disease control.

謝謝你，Bill，各位早安。2026 年對 Ocular Therapeutix 而言是非凡且真正具轉型意義的一年。我們在 SOL-1 取得具里程碑意義的第三期優效性結果，為 AXPAXLI 在濕性 AMD 的首次潛在核准建立了清晰的法規路徑，並持續產出具說服力的臨床證據，顯示 AXPAXLI 的持久性與疾病控制能力。

As we approach the end of the year, I believe we are in the strongest position in our company's 20-year history, with an extraordinary opportunity to fundamentally transform the treatment paradigm for retinal diseases. Today, while several bolus treatment agents are either approved or in development, AXPAXLI stands alone as the only intravitreal sustained-release maintenance agent with positive Phase 3 data in wet AMD. With a competitive landscape evolving significantly in recent months, we believe our opportunity has never been greater.

隨著我們接近年底，我相信我們正處於公司 20 年歷史中最強勢的位置，並擁有一個非凡機會，可從根本上改變視網膜疾病的治療典範。目前，雖然已有數種推注（bolus）治療藥物獲准或正在開發中，但 AXPAXLI 是唯一一個在濕性 AMD 具有正向第三期數據的玻璃體內長效緩釋維持治療藥物。隨著近幾個月競爭格局顯著演變，我們認為我們的機會從未如此之大。

I want to begin by addressing recent competitive developments, because they reinforce the importance of the fundamental principles that have guided our AXPAXLI development strategy from the outset. These include the importance of TKI potency, drug delivery vehicle, and thoughtful clinical trial design, including rigorous patient selection. In drug development, molecular potency matters. The drug's delivery vehicle matters. Rigorous clinical trial design matters, and patient selection matters.

我想先談近期的競爭動態，因為這些發展再次印證了自一開始即指引我們 AXPAXLI 開發策略的基本原則之重要性。這些原則包括：TKI 的效力、藥物遞送載體，以及周全的臨床試驗設計（包含嚴謹的病人篩選）的重要性。在藥物開發中，分子效力很重要。藥物的遞送載體很重要。嚴謹的臨床試驗設計很重要，而病人篩選也很重要。

First, on potency. We have seen potency make a huge difference in wet AMD studies before. For example, Lucentis was considerably more potent than Macugen. Similarly, axitinib, the TKI used in AXPAXLI, has demonstrated the greatest potency of the TKIs currently in development for retinal diseases. Axitinib has approximately a 100-fold greater potency against VEGF receptor 2 when compared to vorolanib, as well as greater potency in the other VEGF receptors.

首先談效力。我們過去已在濕性 AMD 研究中看過效力帶來巨大差異。例如，Lucentis 的效力明顯高於 Macugen。同樣地，AXPAXLI 所使用的 TKI——axitinib——已展現出目前正在開發用於視網膜疾病的 TKI 中最高的效力。與 vorolanib 相比，axitinib 對 VEGF 受體 2 的效力約高出 100 倍，且在其他 VEGF 受體上也具有更高效力。

We believe this distinction is critical to achieving sustained VEGF suppression over extended treatment intervals. Next, delivery matters. As we know from preclinical studies, our bioresorbable hydrogel is capable of delivering consistent daily release of axitinib. The 9- to 12-month durability observed in SOL-1 provides compelling evidence that the hydrogel performs similarly in humans to what we saw preclinically.

我們認為，這項差異對於在延長治療間隔期間達成持續的 VEGF 抑制至關重要。接著，遞送同樣重要。如同我們從臨床前研究所知，我們的可生物吸收水凝膠能夠每日穩定釋放 axitinib。SOL-1 中觀察到的 9 至 12 個月持久性，提供了有力證據，顯示該水凝膠在人類中的表現與我們在臨床前所見相似。

Equally important as TKI potency and the bioresorbable hydrogel selected to deliver VEGF suppression is the clinical trial design and patient selection of each trial being evaluated. SOL-1 and SOL-R randomized different groups of treatment-naive patients, since the trials were deliberately designed to answer very distinct clinical questions. In SOL-1, our objective was to demonstrate superiority in vision maintenance over a single administration of aflibercept two milligrams.

與 TKI 效力及用於達成 VEGF 抑制的可生物吸收水凝膠同等重要的，是各項試驗的臨床試驗設計與病人篩選。SOL-1 與 SOL-R 隨機分派的是不同群體的未治療（treatment-naive）病人，因為這兩項試驗是刻意設計用來回答截然不同的臨床問題。在 SOL-1 中，我們的目標是證明在視力維持方面，相較於單次給予 2 毫克 aflibercept 具有優效性。

Accordingly, we prioritized a challenging population specifically selected to lose vision. Nonetheless, approximately 75% of patients receiving AXPAXLI maintained vision at week 36 primary endpoint, and approximately two-thirds through week 52 following a single injection. In SOL-R, our objective is non-inferiority in BCVA to aflibercept 2 milligrams administered every eight weeks.

因此，我們優先納入一個具挑戰性的族群，該族群被特別挑選為容易出現視力下降。儘管如此，接受 AXPAXLI 的病人中，約 75% 在第 36 週主要終點仍維持視力，且在單次注射後，約三分之二的病人可維持至第 52 週。在 SOL-R 中，我們的目標是相較於每 8 週給予一次 2 毫克 aflibercept，在最佳矯正視力（BCVA）上達成非劣性。

Accordingly, we incorporated a differentiating six-month screening and loading period to exclude from randomization patients with early persistent fluid or significant fluid variability. These patients are known to have negatively impacted historical non-inferiority trials. Contrast this with recent developments from a peer that utilized a TKI that is less potent against VEGF receptor 2 in trials that combined previously treated and treatment-naive patients and randomized patients before the loading phase.

因此，我們納入一個具差異化的 6 個月篩選與負荷（loading）期，以在隨機分派前排除早期持續性積液或積液變異性顯著的病人。已知這些病人會對過往的非劣性試驗造成負面影響。對比之下，近期某同業的進展是在試驗中使用一種對 VEGF 受體 2 效力較低的 TKI，將既往治療與未治療病人混合納入，並在負荷期之前即進行隨機分派。

We believe our peers' results do not reflect a limitation of the TKI class, but rather they underscore the importance of getting all three elements right: the TKI and the delivery vehicle, the trial design, and the patient population. These principles were critical to our success in SOL-1, and we believe they provide a compelling foundation for success in SOL-R.

我們認為，同業的結果並不反映 TKI 類別本身的限制；相反地，這些結果凸顯了三個要素都必須做到位的重要性：TKI 與遞送載體、試驗設計，以及病人族群。這些原則對我們在 SOL-1 的成功至關重要，我們相信也為 SOL-R 的成功提供了有力基礎。

Turning to our regulatory process, our highest near-term priority remains the planned submission of our NDA for AXPAXLI in wet AMD in the fourth quarter of this year. Following our positive pre-NDA meeting in September, we remain aligned with the FDA on our planned submission package. Our NDA will be supported by SOL-1 week 52 efficacy data, SOL-1 and interim SOL-R week 52 safety data, and a comprehensive body of confirmatory evidence.

談到我們的法規流程，我們近期最高優先事項仍是計畫於今年第四季提交 AXPAXLI 用於濕性 AMD 的新藥申請（NDA）。在 9 月正向的 pre-NDA 會議之後，我們仍與 FDA 就計畫提交的資料套件保持一致。我們的 NDA 將由 SOL-1 第 52 週療效數據、SOL-1 與 SOL-R 期中第 52 週安全性數據，以及一套完整的確認性證據所支持。

Importantly, we also plan to submit repeat dosing safety data from patients who have received multiple AXPAXLI injections in both Phase 3 trials as part of the NDA review process. Together, our safety database at the time of submission will include more than 300 patients with at least one year follow-up after AXPAXLI treatment, consistent with FDA requirements. We remain on track to conduct the interim SOL-R safety analysis this quarter, with these results to be incorporated into our planned NDA submission.

重要的是，我們也計畫在 NDA 審查流程中提交重複給藥安全性數據，這些數據來自於在兩項第三期試驗中接受多次 AXPAXLI 注射的病人。合計而言，在提交時我們的安全性資料庫將包含超過 300 名病人，且每位至少有 AXPAXLI 治療後一年的追蹤，符合 FDA 要求。我們仍按計畫於本季進行 SOL-R 期中安全性分析，並將這些結果納入我們計畫中的 NDA 提交。

Throughout this process, we have maintained consistent engagement with the FDA, including our special protocol assessment agreement for SOL-1, our Type C meeting earlier this year, and most recently, our positive pre-NDA meeting in September. We also remained aligned with the agency on pursuing approval through the 505(b)(2) regulatory pathway, which has the potential to shorten the review timeline by up to 60 days compared with the traditional 505(b)(1) pathway for a new molecular entity.

在整個過程中，我們持續與 FDA 保持一致且密切的互動，包括 SOL-1 的特殊方案評估（SPA）協議、今年稍早的 Type C 會議，以及最近在 9 月舉行且結果正向的 pre-NDA 會議。我們也與主管機關就採用 505(b)(2) 法規途徑以尋求核准保持一致；相較於新分子實體採用的傳統 505(b)(1) 途徑，該途徑有可能將審查時程縮短最多 60 天。

This will be an incredibly important milestone for our organization and one that reflects years of disciplined clinical development, rigorous execution, and extensive collaboration with the FDA. The incredible progress that we've achieved only occurs when you have a tremendous team in place.

這將是我們組織一個極其重要的里程碑，也反映了多年來嚴謹自律的臨床開發、嚴格的執行力，以及與 FDA 的廣泛合作。我們所取得的驚人進展，唯有在擁有一支卓越團隊時才可能實現。

Today, you will hear from some of those team members, starting with Dr. Nadia Waheed, Ocular's Chief Medical Officer, who will speak to recent updates regarding our clinical programs. David Robinson, Ocular's Global Chief Commercial Officer, who will then review the transformative commercial opportunity ahead. Nadia, please go ahead.

今天，您將聽到其中一些團隊成員的分享，首先是 Ocular 的首席醫療官 Nadia Waheed 醫師，她將說明我們臨床計畫的最新進展。接著是 Ocular 的全球首席商務官 David Robinson，他將回顧前方具變革性的商業機會。Nadia，請開始。

Thanks, Pravin. Let's start with SOL-R, our second Phase 3 trial in wet AMD. I want to emphasize that our confidence in this important trial remains very strong and continues to grow. While SOL-R efficacy data are not required for our planned NDA submission, we believe positive results could provide additional commercial advantages in the US and support regulatory approvals internationally.

謝謝你，Pravin。我們先從 SOL-R 開始，這是我們在濕性 AMD 的第二項第 3 期試驗。我想強調，我們對這項重要試驗的信心依然非常強，且持續增強。雖然 SOL-R 的療效數據並非我們規劃提交 NDA 所必需，但我們相信正向結果可在美國帶來額外的商業優勢，並支持在國際上的法規核准。

At the recent American Academy of Ophthalmology meeting, we presented a post-hoc analysis using an AI-based assessment of retinal fluid. This analysis demonstrated that approximately 71% of AXPAXLI-treated subjects were quantitatively dry at week eight, meaning they had less than or equal to 10 nL of total fluid volume in the 6 x 6 mm scan. Under this stringent definition of dryness, remarkably, approximately 70% of these subjects remained quantitatively dry through week 36 following a single AXPAXLI injection.

在近期的美國眼科學會（American Academy of Ophthalmology）年會上，我們發表了一項使用 AI 進行視網膜液體評估的事後分析。該分析顯示，在第 8 週時，約 71% 接受 AXPAXLI 治療的受試者達到「量化乾燥」，也就是在 6 x 6 mm 掃描中，總液體體積小於或等於 10 nL。在這一定義嚴格的乾燥標準下，值得注意的是，這些受試者中約 70% 在單次 AXPAXLI 注射後，直到第 36 週仍維持量化乾燥。

We believe these findings provide more than just another illustration of AXPAXLI's potential durability. They offer clinicians a potential roadmap for treatment: achieve initial disease control with a couple of bolus anti-VEGF injections, then transition to AXPAXLI for long-term maintenance treatment. Importantly, recent SOL-1 post-hoc analyses have also provided compelling insights into the relationship between early retinal fluid control durability, and long-term outcomes, reinforcing our confidence in the SOL-R study design.

我們認為，這些發現不僅僅是再次說明 AXPAXLI 可能具備的持久性。它們也為臨床醫師提供了一條潛在的治療路徑：先以數次推注（bolus）的抗 VEGF 注射達到初期疾病控制，之後再轉換至 AXPAXLI 進行長期維持治療。重要的是，近期 SOL-1 的事後分析也對早期視網膜液體控制的持久性與長期結果之間的關係提供了有力洞見，進一步強化我們對 SOL-R 試驗設計的信心。

At last week's Empire Forum in New York City, we presented a separate post-hoc analysis reporting that approximately 28% of AXPAXLI-treated subjects in SOL-1 experienced early persistent retinal fluid or fluid variability, defined as a greater than 30-micron increase in central subfield thickness at week eight. These patients had worse visual outcomes, a 32-week earlier time to supplemental injection, and an increased frequency of needing supplemental injections compared to subjects without early persistent fluid in the same period.

在上週於紐約市舉行的 Empire Forum 上，我們發表了另一項事後分析，報告指出 SOL-1 中約 28% 的 AXPAXLI 治療受試者出現早期持續性視網膜液體或液體波動，其定義為第 8 週中央子區厚度增加超過 30 微米。與同期間未出現早期持續性液體的受試者相比，這些患者的視覺結果較差、需要補充注射的時間提前 32 週，且需要補充注射的頻率更高。

This was consistent across both AXPAXLI and aflibercept-treated patients, reinforcing the importance of early disease stability independent of treatment assignment. This is precisely where the design of SOL-R becomes so important. SOL-R incorporates a six-month pre-randomization period specifically designed to screen out patients with early persistent retinal fluid or significant fluid variability.

這一結果在 AXPAXLI 與 aflibercept 治療患者中皆一致，凸顯早期疾病穩定性的重要性，且不受治療分派影響。這正是 SOL-R 設計之所以如此關鍵的原因。SOL-R 納入一段為期六個月的隨機分派前期，專門用來篩除具有早期持續性視網膜液體或顯著液體波動的患者。

Our preliminary analysis indicates approximately 20% of patients otherwise eligible for SOL-R were excluded from randomization because of these characteristics. This is also consistent with historical expectations and closely aligns with the findings from SOL-1. In short, SOL-R is designed to randomize the very population in which we observed the strongest durability profile for AXPAXLI in SOL-1. As it relates to SOL-R, I would also like to address an important refinement to the primary endpoint, which reflects our priority to protect the integrity of our primary analysis.

我們的初步分析顯示，約有 20% 原本符合 SOL-R 資格的患者，因具備這些特徵而在隨機分派前被排除。這也符合歷史預期，並與 SOL-1 的發現高度一致。簡言之，SOL-R 的設計旨在將我們在 SOL-1 中觀察到 AXPAXLI 具最強持久性特徵的那一族群納入隨機分派。就 SOL-R 而言，我也想說明對主要終點的一項重要精修，這反映了我們優先維護主要分析完整性的考量。

As part of our NDA planning, we will conduct an interim safety analysis on a subset of SOL-R patients to meet the FDA's requirement of at least 300 subjects with one year of AXPAXLI follow-up. We selected week 52 for the interim SOL-R safety analysis because it is consistent with the FDA guidance, aligns with the 52-week follow-up period in SOL-1, and it enables our planned fourth quarter NDA submission.

作為 NDA 規劃的一部分，我們將對 SOL-R 的一部分患者進行期中安全性分析，以滿足 FDA 對至少 300 名受試者具一年 AXPAXLI 追蹤資料的要求。我們選擇第 52 週作為 SOL-R 期中安全性分析的時間點，因其符合 FDA 指引、與 SOL-1 的 52 週追蹤期間一致，並可支援我們規劃於第四季提交 NDA。

With the original primary efficacy endpoint scheduled for week 56, our interim safety analysis would have required unmasking the safety data before all patients completed their primary efficacy assessments. Rather than risk compromising the primary endpoint's statistical integrity, we proactively initiated a process in May, after our Type C meeting with the FDA, to move the primary endpoint from week 56 to week 40.

由於原先主要療效終點設定在第 56 週，我們的期中安全性分析將需要在所有患者完成主要療效評估之前就揭盲安全性資料。為避免危及主要終點的統計完整性，我們在 5 月、於與 FDA 的 Type C 會議之後，主動啟動流程，將主要終點由第 56 週調整至第 40 週。

This change ensures all patients will have completed their primary efficacy assessment before the planned interim safety analysis. Importantly, the new week 40 primary endpoint exceeds the FDA's minimum 36-week requirement outlined in its draft guidance for neovascular AMD and is within the treatment effect observed in SOL-1. Due to the interim safety unmasking, we will incur only a minimal statistical alpha penalty of 0.0001 towards our primary endpoint.

此變更可確保在規劃的期中安全性分析之前，所有患者都已完成主要療效評估。重要的是，新的第 40 週主要終點超過 FDA 在其針對新生血管型 AMD 的草案指引中所列的最低 36 週要求，且落在 SOL-1 所觀察到的治療效果範圍內。由於期中安全性揭盲，我們在主要終點上僅會承擔極小的統計 alpha 懲罰，為 0.0001。

Equally important, we have preserved our key secondary and other secondary endpoints at week 56 and 96, including longer-term evaluations of superiority to aflibercept 8 milligrams and the potential prevention of fibrosis and atrophy relative to aflibercept 2 milligrams . It was important for us to complete the rigorous process of changing the primary endpoint time point, including protocol implementation, IRB approvals, and FDA interactions before conducting the interim safety analysis in SOL-R.

同樣重要的是，我們保留了第 56 週與第 96 週的關鍵次要終點及其他次要終點，包括較長期評估相較於 aflibercept 8 毫克的優越性，以及相較於 aflibercept 2 毫克可能預防纖維化與萎縮的潛力。對我們而言，在 SOL-R 進行期中安全性分析之前，完成變更主要終點時間點的嚴謹流程（包括試驗方案落地、IRB 核准，以及與 FDA 的互動）非常重要。

As for our prior guidance, SOL-R will remain masked through week 96 under our FDA-aligned masking plan, with topline results on track for the first quarter of 2028. I want to emphasize that the foundation of these changes is to preserve the integrity of SOL-R, and they are aligned with the FDA. We believe this approach accomplishes two critically important objectives simultaneously: advancing our near-term NDA submission while preserving the long-term clinical, regulatory, and commercial value of SOL-R.

就我們先前的指引而言，依照與 FDA 一致的盲態計畫，SOL-R 將維持盲態至第 96 週，整體主要結果（topline results）仍預計於 2028 年第一季公布。我想強調，這些變更的基礎在於維護 SOL-R 的完整性，且與 FDA 保持一致。我們相信此作法可同時達成兩項至關重要的目標：推進近期的 NDA 提交，同時保留 SOL-R 的長期臨床、法規與商業價值。

Beyond SOL-1 and SOL-R, we are encouraged by the continued momentum in SOL-X, our long-term open-label extension study, with the vast majority of investigators and eligible patients choosing to participate. Importantly, based on our recent analysis of the up to 12-month durability demonstrated in SOL-1, we are modifying SOL-X's dosing cadence from 24-week treatment intervals to 48-week treatment intervals.

除了 SOL-1 與 SOL-R 之外，我們也對 SOL-X（我們的長期開放標籤延伸研究）持續的動能感到鼓舞，絕大多數研究者與符合資格的患者都選擇參與。重要的是，基於我們近期對 SOL-1 所顯示最長可達 12 個月持久性的分析，我們正將 SOL-X 的給藥節奏由每 24 週一次的治療間隔，調整為每 48 週一次的治療間隔。

Simply put, we believe SOL-1 demonstrated that many patients do not require AXPAXLI treatment every six months, and this change to SOL-X reflects our confidence in AXPAXLI's durability. This modification is expected to provide commercially valuable evidence supporting AXPAXLI's potential for an annual dosing, while also evaluating whether sustained VEGF suppression and earlier initiation of AXPAXLI treatment may reduce fibrosis and atrophy and improve long-term visual outcomes.

簡而言之，我們認為 SOL-1 顯示許多患者不需要每六個月接受一次 AXPAXLI 治療，而對 SOL-X 的這項調整反映了我們對 AXPAXLI 持久性的信心。預期此修改將提供具商業價值的證據，支持 AXPAXLI 具備每年一次給藥的潛力；同時也評估持續的 VEGF 抑制與更早啟動 AXPAXLI 治療，是否可降低纖維化與萎縮並改善長期視覺結果。

Stepping back, our three wet AMD trials are strategically designed to provide clinicians with a comprehensive roadmap for AXPAXLI's use in clinical practice. SOL-1 established superiority over a single injection of aflibercept 2 milligrams, demonstrated durability extending up to 12 months, and characterized performance in a particularly challenging patient population.

回過頭來看，我們的三項濕性 AMD 試驗在策略上是為了向臨床醫師提供一份 AXPAXLI 在臨床實務中使用的完整路線圖。SOL-1 確立了相較於單次注射 aflibercept 2 毫克的優越性，證實持久性可延伸至最長 12 個月，並刻畫了在一個特別具挑戰性的患者族群中的表現。

SOL-R is designed to demonstrate non-inferiority to on-label aflibercept 2 milligrams administered every eight weeks and to establish the safety of repeat AXPAXLI treatment every six months in all patients. SOL-X is designed to evaluate 12-month maintenance dosing and potential long-term visual and anatomic benefits of initiating AXPAXLI earlier in the disease course.

SOL-R 的設計旨在證明相較於依標籤每 8 週給藥一次的 aflibercept 2 毫克具不劣性，並在所有患者中建立每六個月重複 AXPAXLI 治療的安全性。SOL-X 的設計旨在評估 12 個月的維持給藥，以及在疾病進程較早期啟動 AXPAXLI 可能帶來的長期視覺與解剖學效益。

Together, these studies are designed to establish a comprehensive clinical profile supporting AXPAXLI's efficacy, durability, and flexibility, further strengthening its potential to become the preferred sustained-release maintenance therapy in wet AMD. As we advance AXPAXLI towards potential approval, we are increasingly focused on translating its differentiated clinical profile into meaningful benefits for physicians and patients.

綜合而言，這些研究旨在建立一個完整的臨床特徵，支持 AXPAXLI 的療效、持久性與彈性，進一步強化其成為濕性 AMD 首選緩釋維持治療的潛力。隨著我們推進 AXPAXLI 邁向潛在核准，我們也愈發專注於將其差異化的臨床特徵轉化為對醫師與患者具有實質意義的效益。

David will discuss how we're preparing to deliver on that opportunity. David?

David 將討論我們如何準備把握這個機會並加以實現。David？

Thank you, Nadia. Besides the opportunity to work with this tremendous team, I was drawn to Ocular for a simple reason: to redefine the retina disease treatment paradigm and improve patients' lives with AXPAXLI. Our differentiated clinical profile shown in SOL-1, combined with the significant unmet need in the wet AMD market, positions us to redefine the standard of care and deliver meaningful benefits to patients, physicians, and the broader healthcare system.

謝謝你，Nadia。除了有機會與這支卓越的團隊共事之外，我被 Ocular 吸引的原因很簡單：透過 AXPAXLI 重新定義視網膜疾病的治療典範，並改善病患的生活。我們在 SOL-1 中展現的差異化臨床特徵，加上濕性 AMD 市場龐大的未被滿足需求，使我們具備重新定義照護標準的定位，並為病患、醫師以及更廣泛的醫療體系帶來具意義的效益。

Central to realizing this opportunity is our belief that AXPAXLI addresses a fundamentally different treatment need than the anti-VEGF therapies available today. We believe that it's critical to distinguish between bolus anti-VEGF therapies used to achieve initial disease control and AXPAXLI's intended role as a long-term maintenance therapy. Retina specialists have numerous bolus therapies available today, with additional products in development.

實現這個機會的核心，在於我們相信 AXPAXLI 所滿足的是與目前可用的抗 VEGF 療法根本不同的治療需求。我們認為，必須清楚區分：用於達成初始疾病控制的推注式（bolus）抗 VEGF 療法，以及 AXPAXLI 作為長期維持治療的預期角色。目前視網膜專科醫師可使用多種推注式療法，且仍有其他產品在開發中。

Physicians can choose the bolus therapy appropriate for their patients to dry the retina over a brief initiation period before transitioning to AXPAXLI for long-term maintenance, if approved. We view the anti-VEGF therapies as complementary to AXPAXLI rather than direct competitors for our intended maintenance opportunity. Importantly, maintenance represents more than 90% of the wet AMD treatment market.

醫師可以為其病患選擇合適的推注式療法，在短暫的起始治療期間使視網膜乾燥，之後若獲核准，再轉換至 AXPAXLI 進行長期維持治療。我們將抗 VEGF 療法視為與 AXPAXLI 互補，而非在我們預期的維持治療機會上直接競爭。重要的是，維持治療占濕性 AMD 治療市場的 90% 以上。

We believe a long-duration treatment like AXPAXLI will be broadly welcomed, as today's frequent bolus dosing leads to over 40% of patients being lost to therapy in the first year alone. Furthermore, following the recent discontinuation of a peer TKI program in wet AMD, we believe AXPAXLI has no direct late-stage intravitreal sustained-release competitor. Our successful SOL-1 superiority outcome also provides a compelling basis for commercial differentiation.

我們相信像 AXPAXLI 這樣的長效治療將廣受歡迎，因為目前頻繁的推注式給藥，僅第一年就導致超過 40% 的病患中斷治療。此外，隨著近期一項同業在濕性 AMD 的 TKI 計畫中止，我們認為 AXPAXLI 在後期開發階段沒有直接的玻璃體內長效釋放競品。我們在 SOL-1 取得的優效（superiority）結果，也為商業差異化提供了有力基礎。

If AXPAXLI were to receive a superiority label, it could also support premium pricing and potentially help avoid traditional step edit requirements. Our market research demonstrates strong physician interest based on SOL-1 data alone, including our recent post-hoc analysis demonstrating almost 70% of patients remain dry on the strict AI-based algorithm at 36 weeks. We continue to invest in commercial infrastructure, market access, and launch execution capabilities.

若 AXPAXLI 能獲得優效標示（superiority label），也可支持較高的定價，並可能有助於避免傳統的階梯式編輯（step edit）要求。我們的市場調查顯示，僅基於 SOL-1 數據，醫師即展現強烈興趣；其中包括我們近期的事後分析（post-hoc analysis），顯示在嚴格的 AI 為基礎演算法下，於第 36 週仍有近 70% 的病患維持乾燥。我們持續投資於商業基礎建設、市場准入與上市執行能力。

Our payer team has conducted and continues to advance meaningful pre-approval information exchange discussions with 100% of our top priority tier national and regional payer accounts, covering roughly 84% of commercial lives. These conversations have been well received, with clear interest in AXPAXLI's potential to deliver fewer injections and stronger disease control through superior durability.

我們的支付方團隊已與並持續推進與 100% 的最高優先級全國與區域支付方客戶進行具意義的核准前資訊交換（pre-approval information exchange）討論，涵蓋約 84% 的商業保險人群。這些對話反應良好，並清楚顯示對 AXPAXLI 透過更少注射次數與更強疾病控制、以更優的持久性帶來效益的潛力抱持興趣。

Our intention is to be fully prepared for day one following potential approval, with the capabilities and infrastructure necessary to support rapid physician adoption and broad patient access. I look forward to speaking more about our launch preparation activities in the coming months.

我們的目標是在潛在核准後的第一天就做好萬全準備，具備必要的能力與基礎設施，以支持醫師快速採用並讓病患廣泛取得治療。我期待在未來幾個月進一步分享我們的上市準備活動。

With that, I'd like to turn the call back over to Pravin.

接下來，我想把電話會議交回給 Pravin。

Thanks, David. As you've heard today, we are in an exceptional position as we prepare for our planned NDA submission and potential approval in wet AMD. In preparing for launch, today we also announced a change in our board composition as we shift to prioritize commercial expertise. Dr. Riad Sherif has joined our Board of Directors, and Dr. Seung Suh Hong will retire from the board at the end of the year. We are incredibly thankful to Dr. Hong for his contributions to Ocular during his board tenure.

謝謝，David。如各位今天所聽到的，在我們準備按計畫提交 NDA 並爭取濕性 AMD 的潛在核准之際，我們處於極佳的位置。在準備上市的同時，我們今天也宣布董事會組成的變動，因應我們轉向優先強化商業專業能力。Riad Sherif 醫師已加入我們的董事會，而 Seung Suh Hong 醫師將於年底自董事會退休。我們非常感謝 Hong 醫師在其董事任期內對 Ocular 的貢獻。

We are thrilled to welcome Dr. Sherif to Ocular's board at such an important inflection point in our company's evolution. He's a highly accomplished leader with a rare combination of deep ophthalmology experience, global commercial experience, and a proven ability to build and lead successful organizations.

在公司發展如此重要的轉折點，我們非常高興歡迎 Sherif 醫師加入 Ocular 董事會。他是一位成就卓著的領導者，罕見地兼具深厚的眼科經驗、全球商業經驗，以及建立並領導成功組織的實證能力。

Having served in senior leadership roles at Alcon, Novartis, and Sanofi, and now as the CEO of Oculis, Dr. Sherif brings decades of invaluable experience navigating complex global markets, developing commercial strategies, and driving organizational growth. As we advance AXPAXLI toward a potential regulatory approval and prepare to establish Ocular as a global leader in retina, his strategic insights and commercial perspective will be tremendous assets to our board.

Sherif 醫師曾在 Alcon、Novartis 與 Sanofi 擔任資深領導職務，現任 Oculis 執行長，帶來數十年在複雜全球市場中航行、制定商業策略與推動組織成長的寶貴經驗。隨著我們推進 AXPAXLI 邁向潛在監管核准，並準備將 Ocular 打造成全球視網膜領域的領導者，他的策略洞見與商業觀點將成為董事會的重要資產。

We're delighted that he shares our conviction in the transformative potential of AXPAXLI and has chosen to contribute his experience to Ocular's next chapter. In our conversations, Dr. Sherif has shared with me that his conviction only starts with our opportunity in wet AMD, extending to the opportunity for AXPAXLI in non-proliferative diabetic retinopathy as well. In the United States alone, approximately 6.3 million people suffer from this vision-threatening disease, and less than 1% are actually treated.

我們很高興他與我們同樣堅信 AXPAXLI 具備變革性的潛力，並選擇以其經驗投入 Ocular 的下一篇章。在我們的交流中，Sherif 醫師向我分享，他的信念不僅始於我們在濕性 AMD 的機會，也延伸到 AXPAXLI 在非增殖性糖尿病視網膜病變的機會。僅在美國，就約有 630 萬人罹患這種威脅視力的疾病，而實際接受治療者不到 1%。

AXPAXLI has the opportunity to drastically change this unfortunate reality. Enrollment continues to progress in HELIOS-3, our Phase 3 trial evaluating once-yearly AXPAXLI across diabetic retinal disease, including patients with non-center-involving diabetic macular edema. We remain enthusiastic about this substantial opportunity, and you can expect to hear much more about our diabetic retinal disease strategy in 2027. Financially, we are well-positioned to capitalize on the opportunities ahead.

AXPAXLI 有機會大幅改變這個令人遺憾的現況。HELIOS-3 的收案持續推進；這是我們的第 3 期試驗，評估每年一次給藥的 AXPAXLI 於糖尿病視網膜疾病的應用，包含非中心凹受累的糖尿病黃斑水腫病患。我們對這個龐大機會仍充滿期待，並且您可預期在 2027 年聽到更多關於我們糖尿病視網膜疾病策略的內容。在財務方面，我們也具備良好條件以把握未來機會。

We ended the third quarter with $530.6 million in cash and cash equivalents, providing an expected runway into 2028 based on our current assumptions, but excluding the full anticipated expenses of commercializing AXPAXLI. We remain disciplined in our capital allocation while investing strategically in our regulatory, clinical, and commercial priorities.

我們在第三季末持有 5.306 億美元的現金及約當現金；依據目前假設（但不包含 AXPAXLI 商業化的全部預期費用），預計可支應至 2028 年。我們在資本配置上維持紀律，同時在法規、臨床與商業優先事項上進行策略性投資。

Before we move to Q&A, I want to leave you with several important takeaways from today's call. First, we remain on track to submit our NDA this quarter, supported by a comprehensive NDA package and FDA alignment. Second, recent competitive developments reinforce that TKI potency, delivery vehicle, thoughtful clinical trial design, and patient selection are essential for success. These principles have been foundational to our AXPAXLI development strategy and are reflected in our landmark SOL-1 superiority results.

在進入問答之前，我想以今天電話會議的幾項重要重點作結。第一，我們仍按計畫在本季提交 NDA，並有完整的 NDA 套件與 FDA 的一致性支持。第二，近期競爭態勢的發展再次強化：TKI 的效力、遞送載體、周全的臨床試驗設計與病患選擇，對成功至關重要。這些原則一直是我們 AXPAXLI 開發策略的基石，並反映在我們具里程碑意義的 SOL-1 優效結果中。

Third, new SOL-1 post-hoc analyses provide a potential clinical roadmap for AXPAXLI maintenance treatment and reinforce our confidence in SOL-R, with preliminary SOL-R screening data supporting our patient selection strategy. Fourth, our proactive modification of SOL-R's primary endpoint preserves trial integrity and enables our near-term NDA strategy while protecting important longer-term efficacy assessments and remaining in alignment with FDA guidance.

第三，SOL-1 的新事後分析為 AXPAXLI 維持治療提供了潛在的臨床路線圖，並強化我們對 SOL-R 的信心；SOL-R 的初步篩檢數據也支持我們的病患選擇策略。第四，我們主動調整 SOL-R 的主要終點，既維持試驗完整性，也使我們的近期 NDA 策略得以推進，同時保護重要的較長期療效評估，並持續符合 FDA 指引。

Fifth, our three wet AMD trials are designed to establish a compelling and comprehensive clinical profile. SOL-1 demonstrated superiority and durability. SOL-R is designed to demonstrate non-inferiority to on-label aflibercept 2 milligrams and safety of every six-month repeat dosing. SOL-X will evaluate potential long-term benefits of annual AXPAXLI maintenance treatment. Sixth, we believe AXPAXLI has an extraordinary opportunity to establish a new standard of maintenance treatment in wet AMD, and we're building our organization to capitalize on that opportunity.

第五，我們的三項濕性 AMD 試驗旨在建立具說服力且全面的臨床特徵。SOL-1 證明了優效與持久性。SOL-R 的設計旨在證明相較於標示用法的 2 毫克 aflibercept 具不劣效（non-inferiority），並驗證每 6 個月重複給藥的安全性。SOL-X 將評估每年一次 AXPAXLI 維持治療的潛在長期效益。第六，我們相信 AXPAXLI 具備非凡機會在濕性 AMD 建立新的維持治療標準，而我們正打造組織以把握這個機會。

And finally, we continue to advance our broader development program, including our registrational HELIOS-3 study in diabetic retinal disease, positioning Ocular for significant long-term growth. We have never been more confident in our differentiated approach, our execution, and the opportunity ahead. We remain laser-focused on bringing AXPAXLI, if approved, to patients as quickly as possible and delivering on what we believe is a truly transformational opportunity.

最後，我們持續推進更廣泛的開發計畫，包括糖尿病視網膜疾病的註冊性 HELIOS-3 研究，讓 Ocular 具備顯著的長期成長動能。我們對自身差異化方法、執行力以及前方機會的信心前所未有。我們仍高度聚焦於在獲核准的前提下，盡快將 AXPAXLI 帶給病患，並實現我們所相信的真正具變革性的機會。

Thank you, and with that, we would be happy to take your questions.

謝謝，接下來我們很樂意回答各位的提問。

Biren Amin, Piper Sandler.

Biren Amin，Piper Sandler。

Yeah. Hi, guys. Thanks for taking my questions. Maybe on SOL-X and the change in the treatment interval to 48 weeks versus 24 weeks, what new data led to this change? Given wet AMD is a heterogeneous disease, will you offer 48-week frequency to all patients in SOL-X, or will treatment be guided by functional and anatomic endpoints in SOL-X? Thank you.

是的。各位早安。謝謝讓我提問。想請教關於 SOL-X，以及將治療間隔從 24 週改為 48 週，這項改變是基於哪些新數據？鑑於濕性 AMD 是異質性疾病，在 SOL-X 中你們會對所有病患都提供 48 週的給藥頻率嗎？還是會依據 SOL-X 中的功能性與解剖學終點來指引治療？謝謝。

Good morning, Biren. Thank you very much for your question. Let me take a crack at that. I'm fortunate enough to have Nadia here with me, and I'll let her give you the complete and full answer. What I would like to share with you is sort of the package that we have in terms of the information we've provided to clinicians. SOL-X, this change in SOL-X is very much a part of that.

早安，Biren。非常感謝你的問題。我先嘗試回答一下。我很幸運 Nadia 也在我身邊，我會請她給你完整且全面的回答。我想先跟你分享的是，我們就提供給臨床醫師的資訊而言，整體上是一個「套件」。SOL-X 的這項變更正是其中非常重要的一部分。

I want to also add that that is a reflection of our confidence in the data that we continue to analyze in SOL-1, and the data that we continue to analyze in a patient population that's specifically designed to lose vision. People forget that. Remember, this is a very select patient population that's specifically selected to lose vision. The fact that two-thirds of these patients were rescue-free with a single injection at 12 months gives us an enormous amount of confidence.

我也想補充，這反映了我們對持續分析中的 SOL-1 數據，以及我們在一個特別設計為會喪失視力的病患族群中持續分析的數據，所抱持的信心。很多人會忘記這點。請記得，這是一個非常特定的病患族群，是特別挑選出來、預期會喪失視力的。在 12 個月時，這些病患中有三分之二僅靠一次注射就不需要救援治療（rescue-free），這讓我們非常有信心。

Now you've heard our presentation in Academy and more recently in New York that shows the level of disease control that this drug is able to obtain. The decision that was made to prolong the interval is made out of that level of confidence based on the data that we've analyzed. Think of the data set that we'll be presenting to clinicians. There are three of them. First of all, what does SOL-1 answer? SOL-1 tells us, first of all, the safety of this drug.

你們已經在 Academy 的簡報，以及最近在紐約的簡報中聽到我們展示這款藥物能達到的疾病控制程度。延長治療間隔的決策，正是基於我們分析過的數據所帶來的這種信心。想想我們將提供給臨床醫師的數據組合。一共有三個。首先，SOL-1 回答了什麼？SOL-1 首先告訴我們這款藥物的安全性。

We have provided unprecedented patient-level safety data from the onset. I think very few, if anybody, has done that from the onset. SOL-1 also gives you an insight into disease control in this very difficult patient population. What we've shown is that with a single injection of AXPAXLI, at month nine, the OCT is within a stability of 30 microns.

我們從一開始就提供了前所未有、以病患為單位（patient-level）的安全性數據。我想很少有人——如果有的話——從一開始就這麼做。SOL-1 也讓你了解在這個非常棘手的病患族群中的疾病控制情況。我們顯示，僅一次注射 AXPAXLI，在第 9 個月時，OCT 的穩定度在 30 微米以內。

The other thing that SOL-1 shows, as I mentioned, is the durability of this drug, which is with a single injection within this difficult patient population, two-thirds of patients are rescue-free at month 12. Now add SOL-R. With SOL-R, what we'll be able to show is the repeatability of every six-month dosing versus aflibercept on label.

另外，正如我提到的，SOL-1 也顯示了這款藥物的持久性：在這個棘手的病患族群中，僅一次注射，到了第 12 個月仍有三分之二的病患不需要救援治療。接著再加上 SOL-R。透過 SOL-R，我們將能展示每 6 個月給藥一次相較於按標籤使用的 aflibercept，其可重複性（repeatability）。

With SOL-X, what we didn't want to do was to simply duplicate that same information with every six-month dosing. Given the amount of confidence that we now have in this drug, we wanted to provide evidence that this drug can last for a year, especially in a patient population that is already stable. For that reason, we'll provide the every one-year maintenance data, and that's really the logic behind extending SOL-X. We've really given the clinicians, I believe, a roadmap of how to use this drug.

至於 SOL-X，我們不希望只是用每 6 個月給藥一次來重複同樣的資訊。基於我們目前對這款藥物的高度信心，我們希望提供證據，證明這款藥物可以維持一年，特別是在已經穩定的病患族群中。因此，我們將提供每一年一次的維持治療數據，這就是延長 SOL-X 的邏輯。 我相信我們確實已經為臨床醫師提供了一份如何使用這款藥物的路線圖。

We've shown that you can use two bolus agents twice, or two bolus injections, and if the eye is dry, you can go ahead and use AXPAXLI once, and there's an over 70% chance that that eye will remain dry for another nine months. And remember, our definition of dryness is really the most stringent definition, that's within 10 nL of volume that's ever been used. Putting that all together, I think we've really given the clinicians a roadmap of how to use this drug.

我們已經顯示，你可以先用兩種 bolus 藥物各打兩次，或是進行兩次 bolus 注射；如果眼底是乾的（dry），就可以接著只使用一次 AXPAXLI，而該眼在接下來 9 個月仍維持乾燥的機率超過 70%。而且請記得，我們對「乾燥」的定義其實是最嚴格的定義——體積在 10 nL 以內——這是迄今使用過最嚴格的標準。把這些整合起來，我認為我們確實已經為臨床醫師提供了一份如何使用這款藥物的路線圖。

Let me pass this over now to Nadia, who will also give you her view of these three different studies. Nadia?

現在我把時間交給 Nadia，她也會就這三項不同研究分享她的看法。Nadia？

Thank you, Pravin, and thank you, Biren. Pravin, I think you've laid that out really nicely, and I completely agree with what you're saying over here. Let me emphasize, the more we've looked at SOL-1 data and the more we've looked at the various different patient subgroups within the SOL-1 data, the more our confidence in the durability of AXPAXLI has grown, especially in a cohort of patients that are now in the SOL-X study two years out from when they started having active disease.

謝謝你，Pravin，也謝謝你，Biren。Pravin，我覺得你已經把脈絡講得很清楚了，我也完全同意你在這裡所說的。我想強調的是，我們越深入檢視 SOL-1 數據、越深入檢視 SOL-1 數據中的各種不同病患亞群，我們對 AXPAXLI 持久性的信心就越強，特別是在目前納入 SOL-X 研究、距離他們開始出現活動性疾病已經兩年的那一群病患中。

And part of this change is driven by that confidence in the durability and stability that this medication gives us. And I think also our goal all along has been, while each one of the studies selects, in the SOL-1 study, we had a broad cohort of patients that were designed to fail. In the SOL-R study, where we have a cohort of patients that are designed to be stable, together, these represent the majority of patients of wet macular degeneration that clinicians will see in clinic.

而這項變更的一部分，正是由於我們對這個藥物所帶來的持久性與穩定性的信心所驅動。我也認為，我們一路以來的目標是——雖然每一項研究都有其選擇條件——在 SOL-1 研究中，我們納入的是一個廣泛、且被設計為會失敗的病患隊列。在 SOL-R 研究中，我們納入的是一個被設計為穩定的病患隊列；兩者合在一起，代表了臨床醫師在門診會看到的大多數濕性黃斑部退化病患。

And our goal is to provide a roadmap for clinicians to treat these patients, and SOL-X, I think, gives us the opportunity to do that. Of course, we would like not to just recapitulate the data that we're producing in SOL-R that shows stability with every six-month dosing. Over here now, we're going to show you, backed with the data that we have from the SOL-1 study, how you can go to once-a-year dosing. And I think that this is also reinforced by the decisions that we've taken in our diabetic studies of putting these patients on once-a-year dosing.

我們的目標是為臨床醫師提供一份治療這些病患的路線圖，而我認為 SOL-X 讓我們有機會做到這一點。當然，我們不希望只是重述 SOL-R 所產出的數據——也就是每 6 個月給藥一次可維持穩定。在這裡，我們將在 SOL-1 研究數據的支持下，向各位展示如何能夠做到一年一次給藥。我認為這也呼應了我們在糖尿病相關研究中所做的決策：讓這些病患採用一年一次給藥。

Really, as we go along, our confidence in the durability and its ability to maintain stability grows for AXPAXLI, and that's what we're hoping to demonstrate with SOL-X.

總之，隨著研究推進，我們對 AXPAXLI 的持久性以及其維持穩定的能力越來越有信心，而這正是我們希望透過 SOL-X 來證明的。

Thank you, Nadia. Biren, thank you for your question.

謝謝你，Nadia。Biren，謝謝你的提問。

Tazeen Ahmad, Bank of America.

Tazeen Ahmad，美國銀行（Bank of America）。

Hi, good morning, and thank you for taking my questions. Just a couple to clarify. Pravin, on the SOL-X extension study, have you already discussed with FDA that you want to make this change to the endpoint? Just to confirm, is there any read-through to any potential label that you would have with the upcoming filing that you're going to do in the fourth quarter? Also, just remind us how many patients have received multiple doses from SOL-1 and SOL-R, and at what intervals those have happened? Thanks.

嗨，早安，謝謝讓我提問。我有幾點想釐清。Pravin，關於 SOL-X 延伸研究，你們是否已經與 FDA 討論過，想要對終點做這項變更？再確認一下，這是否會對你們預計在第四季進行的申報、以及未來可能取得的標籤（label）有任何可推論的關聯？另外，也請提醒我們，SOL-1 與 SOL-R 中有多少病患接受過多次給藥？給藥間隔分別是多久？謝謝。

Tazeen, good morning, and thank you for your question. Everything that we do is aligned with regulatory agencies. We really don't do anything at all, as you know, without informing, discussing, and being aligned with regulatory agencies. So any changes that are made, including the extension for SOL-X, which again is made out of utter confidence in this drug, has certainly been discussed with and aligned with regulatory agencies. That's very important to say.

Tazeen，早安，謝謝你的問題。我們所做的一切都與監管機構保持一致。如你所知，若未先告知、討論並與監管機構達成一致，我們基本上不會做任何事情。因此，任何變更——包括 SOL-X 的延長——再次強調，這是出於我們對這款藥物十足的信心——都確實已與監管機構討論並取得一致。這點非常重要。

As far as the label is concerned, Tazeen, obviously it's way too early to have labeling discussions, but we expect our label to be what I've been saying from the very beginning. Again, this is our expectation. We aren't in discussions, obviously, with the FDA as yet. We expect to have really the best label that exists in this field. We expect the first and only superiority label.

就標籤而言，Tazeen，很明顯現在談標籤還為時過早，但我們預期我們的標籤會如同我從一開始就一直在說的那樣。再次強調，這是我們的預期。很顯然，我們目前尚未與 FDA 進行討論。我們預期能取得在這個領域中現有最好的標籤。我們預期會是第一個也是唯一一個具備優越性（superiority）標籤的產品。

We expect the flexibility of dosing of every 6 to 12 months with repeatability. As far as repeat dosing is concerned, remember that every patient in SOL-1 at week 52 underwent repeat dosing. Everybody in SOL-R obviously is undergoing repeat dosing. When the FDA does look at our complete filing, they will have plenty of data on repeat dosing based on the SOL-1 patients as well as the SOL-R safety patients that we are going to provide.

我們預期能有每 6 到 12 個月給藥一次、且可重複給藥的劑量彈性。就重複給藥而言，請記得 SOL-1 中每位患者在第 52 週都接受了重複給藥。而 SOL-R 中的所有人顯然也都正在接受重複給藥。當 FDA 審視我們完整的申報資料時，他們將會有大量關於重複給藥的數據可供分析，這些數據來自 SOL-1 患者以及我們將提供的 SOL-R 安全性患者。

Nadia, anything else to add?

Nadia，還有什麼要補充的嗎？

Tazeen, thank you for the question. Pravin, 100% agree. I mean, I think all of the 300 or more than 300 patients that we submit as part of our regulatory safety package, either at baseline or at the safety update, will have received repeat dosing. Indeed, at this point, all of the patients that continue to remain enrolled in our trial, whether that be SOL-1 or SOL-R or the ones that roll over into SOL-X, all of those patients have received repeat dosing.

Tazeen，謝謝你的提問。Pravin，我百分之百同意。我的意思是，我們作為法規安全性資料包提交的 300 名或超過 300 名患者，不論是在基線資料或安全性更新中，都將已接受重複給藥。確實，就目前而言，所有仍持續留在我們試驗中的患者，不論是 SOL-1、SOL-R，或是轉入 SOL-X 的患者，這些患者都已接受重複給藥。

Yeah.

是的。

We have a wealth of data on repeat dosing at this point.

我們目前在重複給藥方面有非常豐富的數據。

Thank you, Nadia. Tazeen, I think the emphasis here is that the FDA will have more than enough repeat dosing data to analyze, and we are very happy to provide that to them. Tazeen, again, thank you very much for your question.

謝謝你，Nadia。Tazeen，我認為這裡的重點是，FDA 將有綽綽有餘的重複給藥數據可供分析，而我們也非常樂意提供給他們。Tazeen，再次非常感謝你的提問。

Tara Bancroft, TD Cowen.

Tara Bancroft，TD Cowen。

Hi, this is Sam on for Tara. Thanks for the update and taking our questions. On the SOL-R primary endpoint change, did the FDA request that you make this change from week 56 to week 40? It would be helpful if you could walk us through the timeline of your regulatory interactions with the agency on this matter, starting from after the Type C meeting until it is finalized. Thank you.

嗨，我是代 Tara 發言的 Sam。感謝更新並回答我們的問題。關於 SOL-R 主要終點的變更，是否是 FDA 要求你們將其從第 56 週改為第 40 週？如果你們能帶我們梳理一下就此事與主管機關互動的時間線，從 Type C 會議之後一直到最終定案，將會很有幫助。謝謝。

Good morning, Sam, and thank you for your question. What I would like to say is, look, we said this from the very beginning, we obviously don't talk about the details of our interactions with regulatory agencies other than to say that there is nothing we do without being aligned with them. Remember what we said from the very beginning regarding SOL-R. We continue to believe that SOL-R, the SOL-R efficacy data, will not be required for approval in the US.

早安，Sam，謝謝你的提問。我想說的是，從一開始我們就說過，我們顯然不會談論與監管機構互動的細節；我們只能說，我們所做的任何事情都會與他們保持一致。請記得我們從一開始對 SOL-R 的說法。我們仍然相信，SOL-R、也就是 SOL-R 的療效數據，在美國獲批並非必要。

We continue to believe more confidently than ever, and I emphasize more confidently than ever, that AXPAXLI will get approved by the US FDA based on a single trial, which is SOL-1, as we've always said with our complete package. However, we've also stated that we believe that SOL-R will be important for some regulatory agencies outside the US.

我們比以往任何時候都更有信心——我強調，比以往任何時候都更有信心——AXPAXLI 將會基於單一試驗（也就是 SOL-1）獲得美國 FDA 核准，正如我們一直所說，並搭配我們完整的資料包。不過，我們也曾表示，我們相信 SOL-R 對於美國以外的一些監管機構會很重要。

We've also stated from the onset that we will do everything possible to protect the integrity of SOL-R, and this is a consistent theme that you have heard. The third thing is we've always said that everything that we do, we do with discussion with and alignment from regulatory agencies.

我們也從一開始就表示，我們會盡一切可能保護 SOL-R 的完整性，而這也是你們一直聽到的一個一致主題。第三點是，我們一直說，我們所做的一切，都是在與監管機構討論並取得一致的情況下進行。

What I'll tell you, Sam, is that the discussion regarding the primary endpoint began immediately after our Type C meeting, which was in May, as you know, and the discussion ranged around how to make sure, above all, that the integrity of SOL-R is protected and that there is no questions whatsoever regarding any operational bias. As you also know, the US FDA regards week 36 as an acceptable one-year primary endpoint if you're using treatment-naive patients. You know this because that's what we have in SOL-1.

Sam，我可以告訴你的是，關於主要終點的討論是在我們的 Type C 會議後立即開始的——如你所知，那是在 5 月——而討論的核心圍繞著如何在最重要的前提下確保 SOL-R 的完整性受到保護，並且對任何操作性偏差（operational bias）完全不會產生疑問。你也知道，如果使用未接受治療的患者（treatment-naive patients），美國 FDA 認為第 36 週可作為可接受的一年主要終點。你之所以知道，是因為 SOL-1 就是這樣設計的。

It made complete sense, and it was completely logical then to say that we would then have an endpoint which would be completely would not necessitate any questions about operational bias if we picked an endpoint where patients had already crossed. At week 40, which is well beyond the week 36 requirement, patients would have already crossed, and there would be absolutely no question about operational bias whatsoever.

因此，這完全合理、也完全合乎邏輯：如果我們選擇一個患者已經交叉（crossed）之後的時間點作為終點，就完全不會引發任何關於操作性偏差的疑問。在第 40 週——遠超過第 36 週的要求——患者已經完成交叉，因此對操作性偏差將完全不會有任何疑問。

Again, this is in line with what we have done to protect the integrity of SOL-R and makes complete sense and is completely aligned with regulatory agencies. Having said that, let me ask Nadia to give us some of her thoughts. Nadia?

再次強調，這與我們為保護 SOL-R 完整性所做的事情一致，完全合理，並且與監管機構完全一致。話說到這裡，我想請 Nadia 分享一些她的看法。Nadia？

Thank you, Pravin, and thank you, Sam, for that question. First and foremost, everything that we do, we are in lockstep and aligned with the regulatory agencies, and everything that we do is focused on, first, ensuring that we have a successful regulatory pathway, and second, ensuring that we have a de-risked regulatory pathway, so that we can get AXPAXLI out to patients as soon as we possibly can. This change is also focused on that dating.

謝謝你，Pravin，也謝謝你，Sam，提出這個問題。首先也是最重要的，我們所做的一切都與監管機構步調一致並保持對齊；我們所做的一切都聚焦於，第一，確保我們有一條成功的法規路徑；第二，確保我們的法規路徑已去風險（de-risked），以便我們能盡快把 AXPAXLI 帶給患者。這項變更也聚焦於那個時程。

The reason for the 40-week change is, the change to 40 weeks for the primary endpoint, as Pravin mentioned, was to ensure that at the time of unmasking of a subset of patients for the FDA, for the NDA submission to the FDA, we wanted to ensure that each and every one of the patients in SOL-R had already crossed their primary endpoint time, and that the database for that was frozen, for the primary endpoint was frozen and locked, so that there was no question whatsoever of operational bias impacting our primary endpoint.

將主要終點改為 40 週的原因，如 Pravin 所提到，是為了確保在我們為 FDA、為向 FDA 提交 NDA 而對一部分患者進行揭盲（unmasking）時，我們希望確保 SOL-R 中每一位患者都已經跨過其主要終點的時間點，且該主要終點的資料庫已凍結（frozen）並鎖定（locked），使得完全不會有任何操作性偏差影響我們主要終點的疑慮。

That is what drove this decision to change the primary endpoint to 40 weeks. Of course, the week 56 remains one of our key secondary endpoints that we will also look at. I think part of this change is to ensure, well, all of this change is to ensure the integrity of the trial, but part of this is also driven by the fact that when we look at the data in SOL-1, we are increasingly confident about both the efficacy as well as the durability of AXPAXLI, no matter what time point along that 56-week or one-year pathway we look at.

這就是促使我們決定將主要終點改為 40 週的原因。當然，第 56 週仍然是我們的一個關鍵次要終點，我們也會加以評估。我認為這項變更的一部分是為了確保——其實這整項變更都是為了確保試驗的完整性——但其中一部分也受到以下因素驅動：當我們檢視 SOL-1 的數據時，我們對 AXPAXLI 的療效以及持久性（durability）越來越有信心，不論我們看的是 56 週或一年路徑上的任何時間點。

At every single time point along those lines in SOL-1, we were seeing exceptionally good results. You saw that presented this weekend when we presented our data, for example, at the Empire Forum, where we saw that patients who were dry at the eight-week time point, that they continued to be dry up to the nine-month time point.

在 SOL-1 中沿著那些時間點的每一個時間點，我們都看到非常出色的結果。你們在這個週末我們發表數據時已經看到，例如在 Empire Forum 上，我們看到在第 8 週時間點達到乾性（dry）的患者，能持續維持乾性直到第 9 個月的時間點。

And so that increasing confidence drove our ability to make these changes and to ensure integrity of our clinical trials, and to have a minimal alpha impact on our primary endpoint as a result. I am going to stop over there, Pravin.

因此，這種日益增加的信心促使我們有能力做出這些變更，以確保臨床試驗的完整性，並使其對我們主要終點的 alpha 影響降到最低。我先說到這裡，Pravin。

Well, thank you, Nadia. Sam, I want to emphasize what Nadia said. We spent a lot of time before talking about how the 56-week primary endpoint was optimal based on peaks and troughs and so on and so forth. We are beyond that at this point, and we are beyond that because we are so confident in the AXPAXLI data based on our SOL-1 analyses that it really does not matter, as Nadia said, what time point we use.

好的，謝謝你，Nadia。Sam，我想強調 Nadia 所說的。我們之前花了很多時間討論為什麼 56 週的主要終點是最佳的，基於峰值與谷值等等因素。但我們現在已經超越那個階段，而之所以能超越，是因為基於我們對 SOL-1 的分析，我們對 AXPAXLI 的數據非常有信心，以至於如 Nadia 所說，使用哪個時間點其實並不重要。

This drug lasts easily for 12 months in the most difficult patient population that you can possibly select, and these are patients who are designed to lose vision. There is no doubt whatsoever in our mind that in a patient population that is super de-risked and super selected to be stable, as we have with a six-month ramp in SOL-R, that at every time point, this drug will succeed.

這款藥物在你所能選擇的、最棘手的病患族群中，也能輕鬆維持 12 個月，而這些病患是被設計成會失去視力的。我們毫無疑問地相信，在一個已高度去風險、且高度篩選為穩定的病患族群中——就像我們在 SOL-R 以六個月的漸進期所建立的那樣——在每一個時間點，這款藥物都會成功。

At this point, rather than trying to optimize the primary endpoint, the more important thing for us really is to protect the integrity of the trial, to have no discussion whatsoever regarding operational bias, and to be completely aligned with regulatory agencies, and that is the reason behind the decision.

在這個時間點，與其試圖去最佳化主要終點，對我們而言更重要的是保護試驗的完整性，完全避免任何關於操作性偏差的討論，並且與監管機構完全一致；這就是做出該決定的原因。

I would just like to add one additional thing over here. I think we have shown very nice data on fluid that demonstrates the zero-order kinetics and the extended release and sustainability of our medication. What we have shown is that, once you have that drying in this population of stable patients, that you have rock-solid control all the way out to nine months, one year.

我想在這裡再補充一點。我認為我們已展示了非常漂亮的液體（fluid）數據，證明我們藥物的零級動力學、延長釋放以及可持續性。我們所展示的是，一旦在這個穩定病患族群中達到乾燥（drying），你就能一路到九個月、一年都維持非常穩固的控制。

We are much less prone to fluctuations than bolus therapies like aflibercept, where there is some up and down with the eight-week bolus dosing. That confidence is really what is driving our ability to make this change.

相較於像 aflibercept 這類推注（bolus）療法——每八週推注一次會有些上上下下的波動——我們更不容易出現波動。正是這份信心，驅動我們有能力做出這項改變。

To add on to that, look, when Nadia talks about rock-solid stability, Sam, I think it is important to emphasize that the criteria that we are using, which is 10 nL, is the most stringent that I know, and it is about as dry as you can get. It is important when people talk about dryness in other studies to ask them, what exactly do you mean by dryness?

再補充一下，聽著，當 Nadia 談到堅若磐石的穩定性時，Sam，我認為很重要的是要強調：我們使用的標準是 10 nL，這是我所知道最嚴格的標準，幾乎已經乾到不能再乾。當人們在其他研究談到乾燥度時，重要的是要問他們：你所說的乾燥到底是什麼意思？

I do not know of any other analysis, any other study that has used a criterion of 10 nanoliters, because it is extraordinarily stringent. When we talk about dryness and rock-solid stability, we really mean this. Remember, this is in the most difficult patient population. This is patients that are specifically selected to lose vision.

我不知道有任何其他分析、任何其他研究使用 10 奈升（nanoliters）的標準，因為那極其嚴格。當我們談到乾燥與堅若磐石的穩定性時，我們是認真的。請記住，這是在最棘手的病患族群中。這些病患是被特別挑選出來會失去視力的。

If we can have that kind of disease control in patients who are specifically chosen to lose vision, we are more confident than ever that we will have superb control, even better control in patients that are specifically de-risked to be as stable as possible. Sam, thank you for your question.

如果我們能在這些被特別挑選為會失去視力的病患中達到這種疾病控制，我們比以往更有信心：在那些被特別去風險、以盡可能穩定為目標的病患中，我們將能達到極佳的控制，甚至更好的控制。Sam，謝謝你的提問。

Lisa Walter, RBC Capital Markets.

RBC Capital Markets 的 Lisa Walter。

Oh, good morning, and thanks for taking our questions. Maybe just another one on the SOL-R primary endpoint change. Just curious if you considered changing the safety interim analysis to week 56 instead to be in line with the timing of the prior primary endpoint. Given the change to 40 weeks, for commercial viability, do you think you will need to hit the secondary endpoint at one year for commercial uptake? Any color here will be helpful. Thanks so much.

喔，早安，謝謝讓我們提問。也許再問一題關於 SOL-R 主要終點變更。我只是好奇，你們是否考慮把安全性期中分析改到第 56 週，以便與先前主要終點的時間點一致。鑑於改為 40 週，從商業可行性的角度，你們認為是否需要在一年時點達成次要終點，才能促進商業採用？任何補充說明都會很有幫助。非常感謝。

Lisa, good morning, and thank you for those questions. First of all, look, the 52-week safety data analysis absolutely coincides with our timing for the full NDA package submission. Again, our discussions with regulatory agencies are something that we don't make public, but it completely also aligns with our discussions with the regulatory agencies. As far as data is concerned for week 40 versus week 56, look, in SOL-X, we'll have data for week 48.

Lisa，早安，謝謝你的問題。首先，52 週的安全性數據分析完全與我們提交完整 NDA 套件的時程一致。同樣地，我們與監管機構的討論不會對外公開，但這也完全與我們和監管機構的討論相一致。至於第 40 週相較第 56 週的數據，請看，在 SOL-X 中，我們會有第 48 週的數據。

We'll have more than sufficient data to show that this drug will last for a year in most patients. If we can, again, it's easy to sometimes overlook the patient population in SOL-1. I want to also, again, emphasize, and I know I've said this before, this is the most difficult patient population. These are patients that were specifically anti-VEGF dependent.

我們將有綽綽有餘的數據來證明，這款藥物在多數病患身上可維持一年。再者，有時候人們很容易忽略 SOL-1 的病患族群。我也想再次強調——我知道我以前說過——這是最棘手的病患族群。這些病患是特別屬於抗 VEGF 依賴型的。

We selected for them, and then we took away the anti-VEGF, and we allowed them to lose vision. That's exactly what we did. In this patient population, if we can have a durability in two-thirds of patients for a year, I think that provides more than enough data based on the longevity of this drug. We believe that that will be even greater when you look at the patient population that's specifically chosen in SOL-R, who are the most stable patients that you can possibly have.

我們把他們篩選出來，然後我們撤掉抗 VEGF，並讓他們失去視力。我們就是這麼做的。在這個病患族群中，如果我們能讓三分之二的病患具有一年的持久性（durability），我認為就已提供了非常充足的數據，足以支持這款藥物的長效性。我們相信，當你看 SOL-R 中特別挑選出的病患族群——也就是你所能擁有的最穩定病患——這個比例會更高。

I want to emphasize what I said earlier on, which is that it's important to look at the totality of our program. Essentially, three different studies here in wet AMD, right? We've got SOL-1, we've got SOL-R, and we have SOL-X. There was absolutely no reason to repeat the data that we would have in SOL-R by treating every six months.

我想強調我先前說過的：重要的是要看我們整個計畫的全貌。基本上，這裡在濕性 AMD 有三個不同研究，對吧？我們有 SOL-1、SOL-R，以及 SOL-X。完全沒有理由在 SOL-R 以每六個月治療一次來重複我們原本就會取得的數據。

We extended that to every 48 weeks. Given together in that triad of programs, I think the clinician will have more than enough information as to the safety, the disease control, as well as the durability of this drug. Nadia, your thoughts?

我們把給藥間隔延長到每 48 週一次。把這三個研究合在一起看，我認為臨床醫師將會有非常足夠的資訊，了解這款藥物的安全性、疾病控制，以及持久性。Nadia，你怎麼看？

Completely agree, and thank you, Lisa, for that question. I think the week 52 time point, by the way, for the safety submission for the FDA makes a lot of sense because it's also consistent with the SOL-1 data, safety data that we have at week 52. So, it just makes it so that all of our patients have that safety cutoff at the same time.

完全同意，也謝謝你，Lisa，提出這個問題。我認為第 52 週這個時間點——順帶一提——用於向 FDA 提交安全性資料非常合理，因為它也與我們在 SOL-1 於第 52 週所取得的安全性數據一致。因此，這讓我們所有病患都能在同一時間點達到安全性截止（cutoff）。

So, I think there's that operational component to it that enables us, that partly drove this decision. Having said that, we'll have obviously safety data not only at the one-year time point, but also at the two-year time point with the SOL-R study, which, as you know, remains masked all the way out to two years.

所以，我認為這裡有一個操作層面的因素，使我們能夠這麼做，也在某種程度上促成了這個決定。話雖如此，透過 SOL-R 研究，我們顯然不只會在一年時間點取得安全性數據，也會在兩年時間點取得；如你所知，該研究會一路盲態（masked）到兩年。

I think SOL-R will provide us a wealth of information that is going to be very useful for clinicians, including superiority against EYLEA HD, and including data on long-term outcomes such as fibrosis at the two-year time point. I think that SOL-R is a critically important study from that perspective.

我認為 SOL-R 會為我們提供大量資訊，對臨床醫師非常有用，包括相較 EYLEA HD 的優效性（superiority），也包括兩年時間點的長期結果數據，例如纖維化（fibrosis）。從這個角度來看，我認為 SOL-R 是一項極其重要的研究。

Having said that, I am sure you are familiar with the data that we just went ahead and presented in SOL-1. I think that we are using post hoc SOL-1 analysis to really provide a roadmap for clinicians to adopt AXPAXLI and to provide guidelines around adoption of AXPAXLI in clinic, and that this is data that it is a gift that keeps on giving.

話雖如此，我相信你也熟悉我們剛剛在 SOL-1 所發表的數據。我認為我們正在使用 SOL-1 的事後（post hoc）分析，真正為臨床醫師提供一份採用 AXPAXLI 的路線圖，並提供在門診採用 AXPAXLI 的指引；而這些數據可說是「持續帶來價值的禮物」。

As you saw in the analysis that we presented, if we treat patients initially to dryness, which is generally one or two or three injections, we then maintain this dryness with a single injection of AXPAXLI all the way out to the nine-month time point. This is data that we presented at both AAO as well as did some additional analyses at the Empire Forum that we presented.

如你在我們發表的分析中所見，如果我們先把病患治療到乾燥（dryness）——通常是一到兩次或三次注射——接著我們就能用單次 AXPAXLI 注射一路維持這種乾燥狀態直到九個月時間點。這些數據我們在 AAO 上也發表過，並且在 Empire Forum 上做了額外分析並進一步呈現。

I think that this is a really nice roadmap around durability and maintenance therapy that we are now providing to clinicians, which I think is going to be really important, especially in this landscape where we may well be the only in-clinic administered durable maintenance therapy available to clinicians. I am going to end with that and Pravin, back to you.

我認為我們現在提供給臨床醫師的是一份非常好的、關於持久性與維持治療的路線圖；我認為這會非常重要，特別是在這樣的環境下，我們很可能是臨床醫師唯一能在門診施行、且具持久性的維持治療選項。我就說到這裡，Pravin，交回給你。

Thank you, Nadia. Lisa, thank you so much for your question.

謝謝你，Nadia。Lisa，非常感謝你的提問。

Jack Allen, Baird.

Jack Allen，Baird。

Hey, everyone. It's Nick on for Jack. Thanks for taking the question. One I had was just on what communication would you all get surrounding the 52-week safety analysis on SOL-R, and would a failure on the primary endpoint halt the study? In other words, if you get past the primary endpoint and we don't hear any news, can we assume that the study is positive? Also on the 52-week SOL-R, on the NDA submission, are there other gating factors on the submission besides hitting that 52-week SOL-R endpoint? Thank you.

嗨，各位。我是 Nick，代替 Jack 發言。謝謝讓我提問。我想問的是，關於 SOL-R 的 52 週安全性分析，你們會收到哪些相關溝通？如果主要終點未達成，是否會停止研究？換句話說，如果我們跨過主要終點後沒有聽到任何消息，是否可以假設研究結果是正面的？另外，關於 52 週 SOL-R，在 NDA 送件方面，除了達成 52 週 SOL-R 終點之外，是否還有其他會影響送件的門檻因素？謝謝。

Nick, again, thank you. Good morning, and thank you for your question. Just to be very clear, as part of the complete NDA package, we are only providing safety data from SOL-R at week 52. That is all that's been requested, and what that does is to fulfill the FDA's requirement of having at least 300 patients who are exposed to the drug. They don't necessarily require the same target. Usually, they would ask you for the same population of patients age-wise.

Nick，再次謝謝你。早安，也謝謝你的提問。我想非常清楚地說明，作為完整 NDA 套件的一部分，我們只會提供 SOL-R 在第 52 週的安全性資料。這就是目前被要求提供的內容，而其目的在於滿足 FDA 的要求：至少要有 300 名病患暴露於該藥物。他們不一定要求相同的目標族群。通常他們會要求年齡層相同的病患族群。

They don't even require the same dose. It can't be a lower dose, but it can be a higher dose. That's why we're providing that safety exposure only, no efficacy, just the safety exposure only from SOL-R as part of our complete NDA submission.

他們甚至不要求相同的劑量。不能是更低的劑量，但可以是更高的劑量。因此，我們在完整 NDA 送件中提供的僅是 SOL-R 的安全性暴露資料，不提供療效資料，只提供安全性暴露資料。

What we don't want to do is during the review process, we don't want to be adding new data that would trigger a major amendment. Because as you know, with a major amendment, the clock starts all over again, and we'll lose the advantage that we have currently being in an accelerated track with the 505(b)(2) designation.

我們不希望在審查過程中新增資料，因為那會觸發重大修正（major amendment）。如你所知，一旦有重大修正，審查時程就會重新起算，我們也會失去目前因 505(b)(2) 指定而處於加速軌道的優勢。

As you know, the card turn for SOL-R will be at week 96, and that has not changed. Up to that point, the study will be completely masked, and all we'll be providing is simply the safety data up to week 52, and that's it. Nothing else. No efficacy data, just the safety data.

如你所知，SOL-R 的揭盲（card turn）會在第 96 週進行，這點沒有改變。在那之前，研究將完全維持盲態，而我們只會提供截至第 52 週的安全性資料，就只有這些。不會有其他內容。沒有療效資料，只有安全性資料。

With what we've done today, what we've ensured is that the integrity of SOL-R will be completely protected because when we provide that week 52 safety data, all the patients will have already crossed what is now the 40-week primary endpoint. So, there's going to be no risk whatsoever of any operational bias, and there's going to be complete protection of the integrity of SOL-R.

我們今天所做的安排，確保 SOL-R 的完整性將受到完全保護，因為當我們提供第 52 週安全性資料時，所有病患都已經跨過目前第 40 週的主要終點。因此，不會有任何作業偏差（operational bias）的風險，SOL-R 的完整性將獲得完全保護。

Let me see if Nadia has some thoughts on this as well.

我看看 Nadia 是否也有一些想法要補充。

Thank you, Nick, for that question. Exactly aligned with what you are saying, Pravin. The SOL-R study, I just want to emphasize, remains masked. It remains masked all the way out to 96 weeks while we freeze the database for the primary endpoint at the 40-week time point before we do the safety unmasking.

謝謝你，Nick，這個問題。我完全同意你所說的，Pravin。我想強調，SOL-R 研究仍維持盲態。在我們於第 40 週時間點為主要終點凍結資料庫、並在進行安全性揭盲之前，研究會一路維持盲態直到第 96 週。

Keep in mind that even within the company, even the safety data is actually masked for the company, and that safety data is getting submitted to the FDA. But overall, for the study itself, we remain completely masked out to week 96.

請記住，即使在公司內部，連安全性資料對公司而言其實也是盲態的，而該安全性資料正在提交給 FDA。就研究本身而言，我們會完全維持盲態直到第 96 週。

There are several good reasons for that, including we need to maintain the masking to be able to produce the superiority data against the aflibercept 8 milligrams, as well as to be able to produce the fibrosis data that we hope to produce, which are all key secondary endpoints for us in the SOL-R study.

這麼做有幾個很好的理由，包括我們需要維持盲態，才能產出相較於 aflibercept 8 毫克的優效性（superiority）資料，以及產出我們希望取得的纖維化（fibrosis）資料；這些都是 SOL-R 研究對我們而言的關鍵次要終點。

Of course, what this enables us to do is leverage the patients in the SOL-R study to provide us with those things, which we believe will be very significant advantages, both adoption-wise as well as commercially, as well as significant advantages of durable maintenance therapy.

當然，這也讓我們能夠運用 SOL-R 研究中的病患來提供上述資料；我們相信這些將帶來非常顯著的優勢，無論是在採用度或商業面，以及在長效維持治療（durable maintenance therapy）方面也會有顯著優勢。

Just based on the going back to what you were saying, just based on the data that we are looking at, for patients that do not have early persistent fluid, which, as you know, was the patient cohort that was removed from the SOL-R study, we only have patients who had no evidence of early persistent fluid.

回到你剛才提到的，根據我們正在檢視的資料，對於沒有早期持續性積液（early persistent fluid）的病患——如你所知，這正是從 SOL-R 研究中移除的那個病患族群——我們目前只納入沒有早期持續性積液證據的病患。

We have presented data at this point that shows us that there is almost no credible paradigm under which SOL-R would not be successful, whether we look at week 40, whether we look at week 56, or whether we look all the way out to week 96.

截至目前我們已呈現的資料顯示，幾乎不存在任何可信的情境會讓 SOL-R 無法成功，不論我們看第 40 週、第 56 週，或一路看到第 96 週。

So our confidence in the success of SOL-R continues to grow the more we look at our data coming out of SOL-1, and the more we look at the data that we have been able to produce out of SOL-1 at this point. Pravin, anything?

因此，隨著我們持續檢視 SOL-1 的資料，以及我們目前能從 SOL-1 產出的資料越來越多，我們對 SOL-R 成功的信心也持續提升。Pravin，你還有要補充的嗎？

No, thank you. Nick, thank you so much for your question.

沒有，謝謝。Nick，非常感謝你的提問。

Thank you. This concludes our question-and-answer session. I will now turn the call back to Dr. Pravin Dugel for closing remarks.

謝謝。我們的問答環節到此結束。接下來我將把電話交回給 Pravin Dugel 醫師做結語。

Thank you. Once again, thank you all for joining us today and for your continued support. We have an incredible opportunity ahead, and we're doing everything in our power to execute on this exciting vision that we have outlined. If you have any questions, please reach out to Bill Slattery, our Vice President of Investor Relations. Have a great day, everyone. Thank you.

謝謝。再次感謝各位今天參與並持續支持我們。我們面前有一個極佳的機會，我們也正竭盡所能去落實我們所描繪的這個令人振奮的願景。如果你有任何問題，請聯絡我們的投資人關係副總裁 Bill Slattery。祝各位有美好的一天。謝謝。

Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.

謝謝。今天的會議到此結束。感謝各位撥冗與會並參與。您現在可以掛線。