Ocular Therapeutix, Inc. (OCUL) 2026 Q1 法說會逐字稿

Good morning, and welcome to the Ocular Therapeutics first 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 Therapeutics website.

各位早安，歡迎參加 Ocular Therapeutics 2026 年第一季財報電話會議。（接線員指示）提醒各位，本次電話會議將被錄音，並可於 Ocular Therapeutics 官網「投資人關係」專區收聽重播。

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.

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 first quarter of 2026.

各位早安，感謝今天與會。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 年第一季的財務結果與業務更新。

During today's call, Ocular's Executive Chairman, President, and CEO, Dr. Pravin Dugel, will summarize recent business highlights before we move to our question-and-answer session. Joining Dr. Dugel for the Q&A portion of the call will be Donald Notman, Chief Operating Officer; Sanjay Nayak, Chief Strategy Officer; and Steve Meyers, Chief Commercial Officer.

在今天的電話會議中，Ocular 的執行董事長、總裁兼執行長 Pravin Dugel 醫師將先總結近期業務重點，之後進入問答環節。與 Dugel 醫師一同參與問答的還有營運長 Donald Notman、策略長 Sanjay Nayak，以及商務長 Steve Meyers。

We refer everyone to this morning's press release and our Form 10-Q for a comprehensive update of our first-quarter 2026 financial and business results.

我們請各位參閱今天早上的新聞稿與我們的 10-Q，以取得 2026 年第一季財務與業務成果的完整更新。

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. Actual results may differ materially as a result of a variety of risk factors, including risks and uncertainties identified in the Risk Factors section of our annual report on Form 10-K and our other SEC filings.

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》安全港條款下的前瞻性陳述。由於多項風險因素，實際結果可能與前瞻性陳述有重大差異，包括我們 10-K 年報「風險因素」章節及其他向美國證券交易委員會（SEC）提交文件中所識別的風險與不確定性。

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？

Thank you, Bill, and thank you all for joining us this morning. 2026 is off to a tremendous start for Ocular Therapeutics, and I want to begin by stating this clearly. SOL-1 has fundamentally changed the conversation in wet AMD.

謝謝你，Bill，也謝謝各位今天早上加入我們。2026 年對 Ocular Therapeutics 而言有一個非常強勁的開局，我想先把話說清楚：SOL-1 已從根本上改變了濕性 AMD 的討論方向。

In February, AXPAXLI became the first novel investigational therapy to demonstrate superiority to an approved anti-VEGF agent in a Phase 3 wet AMD trial. That has never been done before. The magnitude, consistency, and statistical strength of the data with a P value of 0.0006 for our primary endpoint are giving the retina community great confidence in the robustness of the result and the probability of a potential approval as we prepare to submit our NDA based on SOL-1 week 52 data, subject to ongoing formal discussions with the US FDA.

在 2 月，AXPAXLI 成為第一個在第三期濕性 AMD 試驗中，證明優於已核准抗 VEGF 藥物的新型研究性療法。這在過去從未發生過。我們主要終點的 P 值為 0.0006，數據的幅度、一致性與統計強度，讓視網膜社群對結果的穩健性以及潛在核准的可能性充滿信心；我們正準備以 SOL-1 第 52 週數據為基礎提交 NDA，但仍需視與美國 FDA 持續進行的正式討論而定。

But beyond the statistics, what truly excites us is the clinical significance of the data. AXPAXLI delivered unmatched durability and sustained disease control with substantially fewer rescues. In two-thirds of the patients, just a single AXPAXLI injection maintained vision for an entire year. That is not incremental progress, that is true differentiation.

但除了統計之外，真正令我們振奮的是數據的臨床意義。AXPAXLI 帶來無可匹敵的持久性與持續的疾病控制，且需要救援治療的比例顯著更低。在三分之二的患者中，只需一次 AXPAXLI 注射就能維持整整一年的視力。這不是漸進式改善，而是真正的差異化。

Most importantly, we're not slowing down. Just last week, we announced the initiation of enrollment in SOL-X, our long-term extension trial in wet AMD designed to explore AXPAXLI’s impact on the long-term outcomes that matter most to patients and retinal satialists.

更重要的是，我們不會放慢腳步。就在上週，我們宣布啟動 SOL-X（濕性 AMD 的長期延伸試驗）收案，旨在探索 AXPAXLI 對患者與視網膜專科醫師最重視之長期結局的影響。

Since the top-line announcement, we have continued to analyze the SOL-1 results, and each successive data presentation only strengthens our conviction. Both at the Macula Society and most recently at the Vit-Buckle Society Annual Meeting, we presented additional 52-week analyses that further reinforce AXPAXLI’s unprecedented profile.

自公布主要結果以來，我們持續分析 SOL-1 的結果，而每一次後續的數據發表都更強化我們的信念。無論是在 Macula Society，或是最近在 Vit-Buckle Society 年會上，我們都展示了額外的 52 週分析，進一步印證 AXPAXLI 前所未有的特性。

For example, when we look at time-to-fluid volume increases, specifically thresholds of greater than 30 and 75 microns from week eight, subjects treated with AXPAXLI took about five to six months longer to reach those thresholds as compared to subjects in the aflibercept arm. This is exceptional disease control.

例如，當我們觀察液體體積增加的時間（time-to-fluid volume increases），特別是從第 8 週起增加超過 30 與 75 微米的門檻時，與 aflibercept 組相比，接受 AXPAXLI 治療的受試者達到這些門檻的時間約晚了 5 到 6 個月。這代表極佳的疾病控制。

So why does this matter? Fluid is the key marker of disease activity in wet AMD. Lower fluid accumulation reflects slower anatomic progression. And slower anatomic progression reflects sustained disease control. And that has important implications for the long-term, which we are further evaluating in SOL-X.

那麼，為什麼這很重要？液體是濕性 AMD 疾病活動度的關鍵指標。液體累積較少代表解剖學進展較慢；而解剖學進展較慢代表疾病控制得以持續。這對長期結果具有重要意涵，我們也將在 SOL-X 中進一步評估。

Over time, inconsistent or pulsatile VEGF suppression, as we see in today's real-world clinical practice, may contribute to irreversible changes such as fibrosis and atrophy. What AXPAXLI may offer is something fundamentally different, continuous zero-order drug release and consistent disease control, which we believe could significantly alter the long-term trajectory of disease.

隨著時間推移，如同我們在當今真實世界臨床實務中所見，不一致或脈衝式的 VEGF 抑制可能導致不可逆的變化，例如纖維化與萎縮。AXPAXLI 可能提供的是根本不同的機制：連續的零級（zero-order）藥物釋放與一致的疾病控制；我們相信這可能顯著改變疾病的長期走向。

What we have seen to date in SOL-1 with AXPAXLI is not just durability in terms of dosing interval, it is also durability in terms of disease control. And that distinction will continue to be important. Furthermore, when you consider the patients who are randomized in SOL-1, it becomes even clearer that what we have demonstrated with AXPAXLI is simply remarkable.

截至目前，我們在 SOL-1 中看到的 AXPAXLI，不僅是在給藥間隔上的持久性，也是在疾病控制上的持久性，而這個區別將持續重要。此外，當你考量 SOL-1 中被隨機分派的患者族群時，就更能清楚看出我們以 AXPAXLI 所展現的成果確實非同凡響。

It's worth remembering that SOL-1 enrolled what may be the best seeing wet AMD population ever studied in a Phase 3 trial. As you will recall, treatment-naive subjects needed to reach 20/20 vision or gain 10 letters over eight-week screening and loading phase to be randomized into the trial.

值得記住的是，SOL-1 納入的可能是第三期試驗中視力最佳的濕性 AMD 族群。如各位所知，未治療（treatment-naive）的受試者必須在 8 週的篩選與負荷期內達到 20/20 視力或增加 10 個字母，才能被隨機分派進入試驗。

Since we started recruitment, we've consistently said that this population was intentionally selected specifically because they are expected to lose vision. And yet, with a single injection of AXPAXLI, nearly 75% of patients maintained vision at nine months and 66% maintained vision all the way through 12 months. That is simply profound.

自我們開始招募以來，我們一直強調這個族群是刻意挑選的，因為預期他們會出現視力下降。然而，只需一次 AXPAXLI 注射，將近 75% 的患者在 9 個月時維持視力，且 66% 的患者一路維持到 12 個月。這確實非常深遠。

We also saw a meaningfully delayed time to first rescue compared to aflibercept. Incredibly, the rescue rate observed in the aflibercept arm at week 28 was not reached in the AXPAXLI arm until six months later at week 52. Just think about that.

我們也觀察到，與 aflibercept 相比，首次需要救援治療的時間明顯延後。令人驚訝的是，aflibercept 組在第 28 週所觀察到的救援率，直到 6 個月後的第 52 週，AXPAXLI 組才達到。請想想這代表什麼。

We're talking about a six-month delay in clinically meaningful disease change. In wet AMD, that kind of separation has never been seen before, and it speaks directly to the durability and sustained disease control that define AXPAXLI’s profile.

我們談的是在臨床上具有意義的疾病變化延後了 6 個月。在濕性 AMD 中，這種差距過去從未見過，且直接反映出 AXPAXLI 特性所定義的持久性與持續疾病控制。

Most importantly, AXPAXLI’ was shown to be well tolerated and still won. We have made a conscious decision to be extremely transparent with regards to safety, simply because it is so important in retinal vascular diseases.

最重要的是，AXPAXLI 已證實耐受性良好，而且仍然勝出。我們有意在安全性方面保持高度透明，因為在視網膜血管疾病中，安全性至關重要。

In our Macular Society and VBS presentations, we went so far as to provide subject-level details showing that AXPAXLI is performing as exactly as expected and is eluding drug and bioresorbing when it should. We did not observe a single treatment-related serious ocular or systemic adverse event, such as endophthalmitis or vasculitis, that would be cause for concern.

在我們於 Macular Society 與 VBS 的發表中，我們甚至提供了受試者層級的細節，顯示 AXPAXLI 的表現完全符合預期，並且在應該的時間點完成藥物釋放與生物可吸收（bioresorbing）。我們未觀察到任何與治療相關、會引發疑慮的嚴重眼部或全身性不良事件，例如眼內炎或血管炎。

Instead, when you combine our superiority, durability, sustained disease control, and a reassuring safety profile, you begin to see the profile of a product that retina specialists could adopt with confidence. If approved, we believe that AXPAXLI has the potential to become a foundational therapy in wet AMD.

相反地，當你把我們的優效性、持久性、持續疾病控制，以及令人安心的安全性概況結合起來，就能看見一個視網膜專科醫師可有信心採用的產品輪廓。若獲核准，我們相信 AXPAXLI 有潛力成為濕性 AMD 的基礎治療。

Based on the strength of the results, we remain on track to submit our NDA, relying on SOL-1 week 52 data, subject to ongoing formal discussions with the FDA. The FDA continues to publicly communicate plans to move to a single registrational trial as the new default option for approvals.

基於結果的強勁表現，我們仍按計畫推進 NDA 提交，並將依據 SOL-1 第 52 週數據，但仍需視與 FDA 持續進行的正式討論而定。FDA 也持續公開傳達其計畫：將單一註冊性試驗作為核准的新預設選項。

The agency's commissioner recently noted that he expects this new framework to be phased in over the next few months or so, aligning with our goal of bringing AXPAXLI to patients as soon as possible. We intend to leverage the 505(b)(2) pathway, which may further allow for a shortened review timeline.

該機構的署長近期指出，他預期這個新框架將在未來幾個月左右逐步導入，這也與我們盡快將 AXPAXLI 帶給患者的目標一致。我們計畫採用 505(b)(2) 途徑，這可能進一步縮短審查時程。

Importantly, we are accelerating commercial readiness in parallel. We are building the infrastructure, engaging payers, refining our commercial strategy, and preparing for what we believe will be one of the most important launches in retina in many years.

同樣重要的是，我們也在同步加速商業化準備。我們正在建置基礎設施、與支付方互動、精煉商業策略，並為我們認為將是多年來視網膜領域最重要的上市之一做好準備。

Turning to SOL-R, we completed randomization of 631 subjects in December 2025, exceeding our original 555-subject target. Because of this swift enrollment, we recently accelerated our guidance for SOL-R top-line data to the first quarter of 2027.

接著談 SOL-R：我們已於 2025 年 12 月完成 631 名受試者的隨機分派，超出原先 555 名受試者的目標。由於收案迅速，我們近期將 SOL-R 主要數據（top-line data）的指引提前至 2027 年第一季。

This trial was specifically designed to complement SOL-1. Or as SOL-1 demonstrated superiority, SOL-R evaluates non-inferiority in a de-risked population. Importantly, our 24-week screening and loading phase occurs prior to randomization, and this is designed to screen out those subjects with high fluid fluctuations which have notoriously derailed prior non-inferiority trials.

本試驗的設計是為了特別補強 SOL-1。換言之，SOL-1 證明了優效性，而 SOL-R 則在已降低風險的族群中評估非劣效性。重要的是，我們的 24 週篩選與負荷期發生在隨機分派之前，目的在於篩除那些液體波動幅度大的受試者；這類受試者過去眾所周知曾使先前的非劣效性試驗功虧一簣。

The design reflects real-world clinical practice and incorporates rescue criteria more closely aligned with how physicians treat patients. It is powered to provide additional data supporting rapid clinical adoption. Retention in SOL-R is strong, and site engagement remains tremendous. Based on the success of SOL-1, our confidence in SOL-R has never been higher.

此試驗設計反映真實世界的臨床實務，並納入更貼近醫師治療病患方式的救援標準。其統計效力足以提供更多支持快速臨床採用的數據。SOL-R 的受試者留存表現強勁，且各試驗中心的參與度依然非常高。基於 SOL-1 的成功，我們對 SOL-R 的信心從未如此之高。

In addition to SOL-1 and SOL-R, we are thrilled to have recently announced the initiation of enrollment in SOL-X, our open-label long-term extension study in wet AMD. Following the remarkable results from SOL-1 were AXPAXLI demonstrated unmatched durability and sustained disease control, SOL-X is designed to evaluate the long-term outcomes that matter most to patients and physicians.

除 SOL-1 與 SOL-R 外，我們也很高興近期宣布啟動 SOL-X 的收案；SOL-X 為我們在濕性 AMD 的開放標籤長期延伸研究。承接 SOL-1 的卓越結果——AXPAXLI 展現無可匹敵的持久性與持續的疾病控制——SOL-X 旨在評估對病患與醫師最重要的長期結局。

Subjects who have completed two-year follow-up in SOL-1 or SOL-R will now have an opportunity to receive AXPAXLI for an additional three years in SOL-X, bringing the total follow-up to five years. And that is critical because wet AMD is a chronic disease.

已完成 SOL-1 或 SOL-R 兩年追蹤的受試者，現在將有機會在 SOL-X 中額外接受 AXPAXLI 治療三年，使總追蹤期達到五年。而這點至關重要，因為濕性 AMD 是一種慢性疾病。

In clinical practice, we see the consequences of inconsistent disease control over time, progressive damage that can ultimately limit long-term visual outcomes, including through fibrosis and atrophy. Because all subjects in SOL-X will ultimately transition to AXPAXLI, we will have a unique opportunity to observe the consequences of delaying AXPAXLI treatment.

在臨床實務中，我們看到隨時間推移疾病控制不一致所帶來的後果：進行性損傷最終可能限制長期視覺結局，包括纖維化與萎縮所致的影響。由於 SOL-X 中所有受試者最終都將轉換至 AXPAXLI，我們將有獨特機會觀察延後 AXPAXLI 治療所造成的後果。

Patients initially treated with aflibercept in SOL-1 and SOL-R are exposed to what we would describe as pulsatile VEGF suppression, where disease control can fluctuate over time, compared to the continuous suppression we have observed with AXPAXLI. If that difference translates into worse long-term outcomes for patients who begin on aflibercept and switch later, it would provide physicians with a clear rationale to initiate AXPAXLI earlier in the disease course rather than waiting.

在 SOL-1 與 SOL-R 中最初以 aflibercept 治療的病患，暴露於我們所稱的「脈衝式」VEGF 抑制之下，亦即疾病控制可能隨時間波動；相較之下，我們在 AXPAXLI 觀察到的是連續性抑制。若此差異轉化為「先用 aflibercept、之後再轉換」的病患出現較差的長期結局，將為醫師提供明確理由：在疾病早期即啟動 AXPAXLI，而非等待之後才開始。

If successful, this has implications far beyond durability. It has the potential to improve long-term vision outcomes, reduce cumulative treatment burden, and importantly, keep significantly more patients on therapy overtime, which we believe could meaningfully expand the overall market.

若能成功，其意義將遠不止於持久性。它有潛力改善長期視力結局、降低累積治療負擔，且更重要的是，讓顯著更多病患能隨時間持續接受治療；我們相信這可能實質擴大全體市場。

So when we think about AXPAXLI, we're not just thinking about a more durable therapy. We're thinking about a therapy that has the potential to be transformative over the long-term. And SOL-X is a critical step in potentially demonstrating that.

因此，當我們談到 AXPAXLI 時，我們不僅是在思考一種更具持久性的療法；我們思考的是一種有潛力在長期帶來變革的療法。而 SOL-X 是可能證明這一點的關鍵一步。

Beyond wet AMD, our HELIOS-3 trial in diabetic retinopathy remains ongoing. This is a superiority study designed to support a broad label across diabetic retinal disease. It allows enrollment of patients with non-central involved DNA, reflecting the continuum of disease in clinical practice.

除濕性 AMD 之外，我們在糖尿病視網膜病變的 HELIOS-3 試驗仍在進行中。這是一項優效性研究，旨在支持涵蓋糖尿病視網膜疾病的廣泛適應症標籤。該試驗允許收納非中央受累的 DME 病患，反映臨床實務中疾病的連續譜。

On June 17, in New York City, we will host an Investor Day and plan to provide several important updates across our portfolio. We will provide regulatory updates regarding our NDA submission plan in wet AMD, detailed updates on SOL-R and SOL-X, program updates on diabetic retinopathy, and a first look at our planned commercialization strategy for AXPAXLI.

6 月 17 日，我們將在紐約市舉辦投資人日，並計畫就我們的產品組合提供數項重要更新。我們將提供濕性 AMD 的 NDA 申請提交計畫之法規更新、SOL-R 與 SOL-X 的詳細進展、糖尿病視網膜病變專案更新，以及首次揭示我們針對 AXPAXLI 的商業化策略規劃。

In addition to ocular leadership, we will feature leading retinal KOLs who will share their perspective on the SOL-1 data, expectations for SOL-R, the evolving wet AMD treatment landscape, and how AXPAXLI could be adopted immediately if approved. We hope you all plan to join us either in-person or virtually for what we expect will be an important day outlining the future of Ocular Therapeutics.

除眼科領域的領導團隊外，我們也將邀請頂尖視網膜 KOL 分享其對 SOL-1 數據的觀點、對 SOL-R 的期待、濕性 AMD 治療版圖的演變，以及 AXPAXLI 若獲核准將如何能立即被採用。我們希望各位無論親臨現場或線上參與，與我們一同度過我們預期將是重要的一天，勾勒 Ocular Therapeutics 的未來。

As of March 31, our financial position continues to remain strong. We ended the first quarter with approximately $667 million in cash, which we expect to provide us runway into 2028. That provides us the flexibility to advance the NDA submission, complete the second year of SOL-1; continue SOL-R, SOL-X, and our HELIOS program; and accelerate commercial readiness.

截至 3 月 31 日，我們的財務狀況仍然穩健。我們在第一季末持有約 6.67 億美元現金，預期可支應我們的營運至 2028 年。這使我們具備彈性以推進 NDA 提交、完成 SOL-1 的第二年、持續推動 SOL-R、SOL-X 與 HELIOS 計畫，並加速商業化準備。

However, our cash runway does not include the full expenses we anticipate we will need to support the commercialization of AXPAXLI. We remain disciplined stewards of capital while investing strategically in what we believe is a transformational opportunity.

然而，我們的現金可支應期間並未包含我們預期為支持 AXPAXLI 商業化所需的全部費用。我們在策略性投資於我們認為具變革性的機會之同時，仍將以嚴謹態度管理資本。

Before we turn to Q&A, I'd like to close with a few important messages summarizing our incredible position coming out of the first quarter. AXPAXLI has now demonstrated through SOL-1 the first successful superiority outcome for a novel investigative agent in wet AMD against an approved anti-VEGF, unmatched durability with sustained disease control through one year, a safety profile that supports broad clinical adoption.

在進入問答之前，我想以幾點重要訊息作結，總結我們在第一季結束後所處的絕佳位置。AXPAXLI 透過 SOL-1 已證明：在濕性 AMD 中，作為新型研究用藥物，首次成功相較於已核准的抗 VEGF 藥物達成優效性結果；在一年期間展現無可匹敵的持久性與持續的疾病控制；並具備支持廣泛臨床採用的安全性概況。

In addition with the initiation of SOL-X, we now have a clear path to evaluating long-term outcomes with AXPAXLI and its potential to fundamentally alter the trajectory of disease. Together, we believe this combination has the potential to redefine the retina experience. Our organization is energized, the data are compelling, execution remains exceptional, and we're advancing with urgency toward our planned NDA submission and potential commercialization.

此外，隨著 SOL-X 的啟動，我們現在有一條清晰路徑可評估 AXPAXLI 的長期結局，以及其從根本改變疾病進程的潛力。我們相信，這樣的組合有潛力重新定義視網膜治療體驗。我們的組織士氣高昂，數據具說服力，執行力依然卓越，我們正以緊迫感推進既定的 NDA 提交計畫與潛在商業化。

Thank you all for your continued support. Operator, we can now take our first question.

感謝各位持續的支持。接線員，我們現在可以開始第一個問題。

(Operator Instructions) Tazeen Ahmad, Bank of America.

（接線員指示）Tazeen Ahmad，美國銀行。

Thanks for taking my question, and thanks for all of the clarification on timelines. Pravin, I just wanted to get a sense of how the discussions with FDA are going. So a couple of things.

謝謝讓我提問，也謝謝你們對時程的各項釐清。Pravin，我想了解一下你們與 FDA 的討論進展如何。有幾點想請教。

You've been confident on your view that you can apply with just SOL-1 to get approval. But today, you provided the good news that SOL-R has enrolled at a pace that you're going to be able to have [VITA] in the first quarter. So maybe, can you walk us through the scenarios of what the timeline differences would be if it's decided that you can apply with SOL-1 versus a decision that it might be better to wait for SOL-R?

你們一直很有信心認為僅憑 SOL-1 就能提出申請並獲得核准。但今天你們帶來好消息：SOL-R 的收案速度很快，讓你們能在第一季取得 [VITA]。所以也許你能帶我們走一遍不同情境：若決定可以用 SOL-1 申請，與若決定等待 SOL-R 會更好，兩者在時程上會有哪些差異？

Good morning, and thank you so much for the question, very appropriate question. Look, what we've said today and what we've said in the past is that we have ongoing formal discussions with the FDA. We couldn't be happier -- and I want to stress, we couldn't be happier -- with the collaboration that we have with the FDA.

早安，也非常感謝這個問題，確實是很恰當的問題。你看，我們今天以及過去所說的是：我們與 FDA 之間有持續進行的正式討論。我們再高興不過——我要強調，我們再高興不過——能與 FDA 有如此良好的合作。

We feel we're more aligned with the FDA's goals than ever. We check all the boxes. And what's been demonstrated to us over and over again in our discussions and in the writings of the FDA is that there are two things that are really important with this single trial submission that I think everybody ought to note.

我們覺得自己與 FDA 的目標比以往任何時候都更一致。我們符合所有要求。在我們的討論以及 FDA 的書面文件中，一再向我們顯示：就這種單一試驗提交而言，有兩件事非常重要，我想大家都應該注意。

First of all, it's a default position for the FDA. And second, the FDA views this as an elevation of the standards for a clinical trial. This is not a lowering of the bar; this is a raising of the bar. And as such, SOL-1 checks all the boxes.

第一，這是 FDA 的預設立場。第二，FDA 將其視為提升臨床試驗標準。這不是降低門檻；而是提高門檻。因此，SOL-1 符合所有要求。

It has a [SPA]. It checks all the boxes in terms of the superiority standard that was reached in terms of safety. So we're more aligned than ever.

它有 [SPA]。就安全性而言，也在達成的優效性標準方面符合所有要求。所以我們比以往任何時候都更一致。

In terms of your question regarding SOL-R, look, we haven't disclosed the timelines as yet. We will when appropriate. But I remind you that we have a lot of flexibility here in terms of SOL-R.

至於你關於 SOL-R 的問題，你看，我們目前尚未披露時程。我們會在適當時機披露。但我也提醒你：就 SOL-R 而言，我們在這裡有很大的彈性。

Nothing is changing with SOL-R. We're continuing with SOL-R with the same kind of efficiency that we've always demonstrated. We are very happy with the engagement of the PIs and the enrollment of SOL-R, and nothing has changed.

SOL-R 沒有任何改變。我們正以一如既往所展現的效率持續推進 SOL-R。我們對主要研究者（PI）的投入程度與 SOL-R 的收案情況非常滿意，一切都沒有改變。

And again, I want to reiterate, we have ongoing formal discussions with the FDA. We couldn't be happier. And when the time is appropriate, we certainly will update you.

再次重申，我們與 FDA 有持續進行的正式討論。我們再高興不過。當時機適當時，我們當然會向各位更新。

Biren Amin, Piper Sandler.

Biren Amin，Piper Sandler。

And I just want to welcome back Donald. Great to have you back, Donald.

我也想歡迎 Donald 回來。很高興你回來，Donald。

So regarding the ongoing formal discussions with the FDA, Pravin, can you maybe just talk about if you've had the pre-NDA meeting with the FDA? So that's the first question.

關於與 FDA 持續進行的正式討論，Pravin，你能否談談你們是否已與 FDA 召開 pre-NDA 會議？這是第一個問題。

And then second question, for SOL-1 in the past, you provided a snapshot on patient discontinuations and patient retention in the study. I was wondering if you could discuss these dynamics for the SOL-R study.

第二個問題，過去針對 SOL-1，你們曾提供病患中止與留存的概況。我想請問你們能否也談談 SOL-R 研究在這些面向的情況？

And thank you for the personal note regarding Donald. We too are absolutely thrilled to have Donald back, and he's an essential part of our team. And we couldn't be happier that he's back with us.

也謝謝你對 Donald 的個人致意。我們同樣非常高興 Donald 回歸，他是我們團隊不可或缺的一員。我們再高興不過他能回到我們身邊。

In regards to the FDA meetings, again, I want to emphasize what I said earlier on, Biren, which is that we are not in the habit of disclosing the details of our FDA meetings, as is true for most sponsors. Suffice it to say that we have ongoing formal meetings that we're very, very pleased with.

關於 FDA 會議，我再次強調我先前對你說的，Biren：我們不習慣披露與 FDA 會議的細節，多數申辦方也都是如此。簡而言之，我們有持續進行的正式會議，而且我們非常、非常滿意。

The collaboration with the FDA today, and as has been demonstrated historically, could not be better. You recall all the modifications that we've had and have preserved our SPA with this study.

我們今天與 FDA 的合作，以及如同過往歷史所展現的，已經好到不能再好。各位還記得我們做過的所有修改，而我們也在本研究中保留了我們的 SPA。

We also recall the modifications that we've had with the SOL-R study. All of those have been done in collaboration with the FDA, and we couldn't be happier with their support and their collaboration. And as I said earlier, when appropriate, we certainly will update you regarding the timelines.

我們也記得在 SOL-R 研究中所做的修改。這些全都是與 FDA 協作完成的，我們對他們的支持與合作感到非常滿意。正如我先前所說，在適當的時候，我們當然會就時程更新各位。

In regards to SOL-R, again, a very appropriate question. As you recall, we had a phenomenal retention rate and execution with SOL-1. That has not changed in SOL-R. We're very, very pleased with the execution. We're very, very pleased with the stats that we have in regards to patient retention.

關於 SOL-R，這同樣是非常恰當的問題。如各位所記得，我們在 SOL-1 的受試者留存率與執行表現都非常出色；在 SOL-R 也沒有改變。我們對執行狀況非常、非常滿意；對於病患留存相關的統計數據也非常、非常滿意。

And you'll hear the details of that in our upcoming Investigator Day. And I hope that -- Investor Day, I'm sorry. I hope that all of you will be present for that in New York City on June 17.

而各位會在我們即將舉行的研究者日聽到相關細節。我是說投資人日，抱歉。我希望各位都能在 6 月 17 日於紐約市出席。

Tara Bancroft, TD Cowen.

Tara Bancroft，TD Cowen。

So I'm going to stick on this theme, if I may. I understand you can't give exact timing and all of that, of course, to preserve the integrity of the discussions, but I was hoping maybe you could go over with us what has to be done ahead of a filing just to get a better sense of the process as you understand it.

如果可以的話，我想延續這個主題。我理解你們當然不能提供精確時點等資訊，以維護討論的完整性，但我希望你們能否為我們概述一下，在提交申請之前需要完成哪些工作，好讓我們更了解你們所理解的流程。

And then kind of separately and related, potentially, timing to when we could get an update on data from SOL-X and whether this is going to be part of that review that's expected for the NDA.

另外一個相關但可能分開的問題是：我們何時可能收到 SOL-X 數據的更新？以及這是否會成為預期 NDA 審查的一部分？

Good morning, and thank you for the question. Look, in regards to the FDA again, I'll repeat that we check all the boxes. We're completely aligned. And I think everything that you've seen from the FDA is in line with their intention of getting drugs to patients faster and making sure that the trials or the single trial approval process is validated.

早安，謝謝你的提問。關於 FDA，我再重申一次：我們把所有該勾選的項目都勾上了。我們完全一致。我認為你們從 FDA 看到的一切，都符合他們希望更快把藥物帶給病患、並確保試驗或單一試驗核准流程獲得驗證的意圖。

You've seen all the editorials of the editorial in New England Journal of Medicine. You've seen the criteria that was laid out by the commissioner. We check all the boxes. And in our discussions with the FDA, we're more confident than ever that we check all the boxes.

你們看過《新英格蘭醫學雜誌》的社論，也看過署長提出的標準。我們全部符合。在與 FDA 的討論中，我們比以往任何時候都更有信心：我們確實把所有項目都勾上了。

In addition to that, as I said earlier, SOL-R also provides us a tremendous amount of flexibility. It's important to note again that nothing has changed with SOL-R. We're moving with SOL-R as efficiently, as quickly with a great deal of integrity. And nothing is going to change with that. So we're moving with that and preserving the flexibility of whatever the FDA should desire.

此外，如我先前所說，SOL-R 也為我們提供了極大的彈性。再次強調，SOL-R 沒有任何改變。我們以高效率、快速且高度嚴謹的方式推進 SOL-R，而這點不會改變。因此我們會持續推進並保留彈性，以因應 FDA 可能提出的任何需求。

In regards to your question regarding SOL-X and the updates, we will provide more updates in our meeting in June in New York City. Important to remember that SOL-X will provide some very important information in regards to the long-term effectiveness of AXPAXLI.

至於你關於 SOL-X 與更新的問題，我們會在 6 月於紐約市的會議上提供更多更新。重要的是要記得，SOL-X 將提供一些關於 AXPAXLI 長期有效性的非常重要資訊。

As has been mentioned, SOL-X will provide a lot of data. Probably one of the most important data points that SOL-X will provide are the crossover patients. We said earlier that there's a great deal of evidence in our field that what causes long-term decrease in vision is atrophy and fibrosis that is caused by the pulsatile nature of our treatment.

如先前所提，SOL-X 會提供大量數據。SOL-X 可能提供的最重要數據點之一，是交叉治療（crossover）的病患。我們先前說過，在我們領域有大量證據顯示，造成長期視力下降的原因是萎縮與纖維化，而這是由我們治療的脈衝式特性所導致。

I've also mentioned several times that that's akin to having multiple concussions because after all, this is neural tissue. We believe that with continuous suppression that AXPAXLI will provide -- and by eliminating these pulsations, we will have a much better long-term outcome by having less fibrosis and less atrophy.

我也多次提到，這類似於多次腦震盪，因為畢竟這是神經組織。我們相信，AXPAXLI 所提供的持續抑制——並藉由消除這些脈衝——將能帶來更好的長期結果，因為纖維化更少、萎縮更少。

And remember, in SOL-X, patients will cross over to AXPAXLI after receiving two years of pulsatile treatment. So we don't think those patients will ever catch up. And we believe that we'll be able to demonstrate not only the remarkable sustainability and absolutely incredible disease control that we've seen with SOL-1, but we believe we'll also be able to provide substantial evidence that it will provide a better long-term outcome by having continuous suppression.

而且請記得，在 SOL-X 中，病患在接受兩年的脈衝式治療後會轉換到 AXPAXLI。因此我們不認為那些病患能夠追趕上來。我們相信，我們不僅能展示我們在 SOL-1 所看到的卓越持久性與極其驚人的疾病控制能力，也相信我們能提供充分證據顯示：透過持續抑制，它將帶來更好的長期結果。

And again, more details on that, Tara, in our meeting in June in New York City, which I hope you will attend.

Tara，關於這點我們會在 6 月於紐約市的會議中提供更多細節，我也希望你能出席。

Sean McCutcheon, Raymond James.

Sean McCutcheon，Raymond James。

This is Yang on for Sean. Maybe, can you speak to the optionality of adding SOL-R to the safety database for the NDA submission and also the risk of unmasking SOL-R if left on the table as it relates to maintaining the integrity of SOL-R for global approvals?

我是代替 Sean 的 Yang。想請問你能否談談：在 NDA 送件時把 SOL-R 納入安全性資料庫的可選性（optionality），以及如果把 SOL-R 擱置不納入，為了維持 SOL-R 用於全球核准的完整性，是否存在揭盲 SOL-R 的風險？

Good morning, and thank you again for the question, very appropriate question. So I don't want to speak again, as I said earlier on, to the details of our conversations with the FDA. Again, suffice it to say that they're very collaborative, supportive, ongoing, and formal.

早安，再次謝謝你的提問，這是非常恰當的問題。如我先前所說，我不想談及我們與 FDA 對話的細節。只要說明一點：他們非常合作、支持，溝通持續進行，且是正式的。

What I will say is we have no intention of doing anything different to SOL-R whatsoever. The flexibility that that provides us in terms of the safety database is enormous, let alone the fact that we also have the HELIOS study.

我能說的是：我們完全沒有任何意圖對 SOL-R 做出任何不同的處理。它在安全性資料庫方面為我們提供的彈性非常巨大，更不用說我們還有 HELIOS 研究。

It's important to remember that in SOL-1, everybody at week 52 has been redosed. So in SOL-1 alone, there's a great deal of redosing experience. Obviously, there's a great deal of redosing experience in SOL-R as well. So again, that affords us a great deal of flexibility.

重要的是要記得，在 SOL-1 中，所有人在第 52 週都已再次給藥。因此僅 SOL-1 就累積了大量再給藥經驗。顯然，SOL-R 也同樣有大量再給藥經驗。所以這再次為我們提供了很大的彈性。

On top of that, it's important to note that what we're filing is a 505(b)(2) because both of these entities are previously FDA approved. So this drug has a lot of familiarity with the FDA. And on top of that, we have a SPA, which we believe will also add to a very efficient filing.

此外，重要的是要注意，我們提交的是 505(b)(2)，因為這兩個成分都已先前獲 FDA 核准。因此 FDA 對這個藥物非常熟悉。再加上我們有 SPA，我們相信這也將有助於非常高效率的送件。

Lisa Walter, RBC Capital Markets.

Lisa Walter，RBC Capital Markets。

Thanks for taking your question, and congrats on the progress this quarter. A couple for me.

謝謝讓我提問，也恭喜本季的進展。我有幾個問題。

On SOL-R, just wondering if you can walk us through the secondary endpoints that you expect to share. And maybe, could you tell us how you are measuring reduction in injection burden as well? Any color here would be helpful.

關於 SOL-R，我想請問你能否帶我們了解一下你們預期會分享的次要終點（secondary endpoints）？另外，你們如何衡量注射負擔的降低？如果能提供一些補充說明會很有幫助。

Good morning , and thank you again. In SOL-R, we certainly will plan to share the details with you of what we will study in our meeting in June. So wait for the details for that. In terms of injection burden, obviously, we're going to be measuring the rescue rates. And again, we'll share the details with that in our meeting in June.

早安，再次謝謝。在 SOL-R 方面，我們確實計畫在 6 月的會議上與各位分享我們將研究的細節，所以請等待那時的細節。至於注射負擔，顯然我們會衡量救援治療（rescue）的比率。我們也會在 6 月的會議上分享相關細節。

It's important to state that I think a lot of the questions that you've asked, that you're concerned about, which is very appropriate, have already really been answered in SOL-1. In SOL-1, we certainly see the disease control of AXPAXLI.

我想強調的是，我認為你提出、你所關切的許多問題——這非常合理——其實在 SOL-1 中已經得到回答。在 SOL-1 中，我們確實看到了 AXPAXLI 的疾病控制能力。

It's important to remember the patient population difference in SOL-R and SOL-1. In SOL-1, patients were specifically and intentionally selected to lose vision, and that's important to understand. And I think that's something that has often been neglected.

重要的是要記得 SOL-R 與 SOL-1 的病患族群差異。在 SOL-1 中，病患是特別且刻意被選入為會失去視力的族群，這點很重要需要理解。我認為這一點常常被忽略。

Despite that patient population, we saw an almost 75% rescue-free rate at week 36, and that's quite remarkable. Perhaps more remarkable, and perhaps even more clinically relevant, is that with a single injection, despite that patient population, 56% maintained a stable CST within 30 microns -- again, I emphasize, 30 microns -- at that time point; and that's unheard of.

儘管是那樣的病患族群，我們在第 36 週仍看到接近 75% 的無需救援治療（rescue-free）比率，這相當驚人。或許更驚人、也可能更具臨床相關性的是：在僅一次注射下，儘管是那樣的病患族群，仍有 56% 在該時間點維持穩定的 CST，變動在 30 微米以內——我再次強調，30 微米——這是前所未見的。

And remember, using the SOL-R criteria, almost 80% of patients were rescue-free in SOL-1 at six months. And we feel that those 20% would perhaps be excluded in SOL-R, given our very long ramp and given the fact that we have two opportunities to observe patients for fluctuations.

而且請記得，若使用 SOL-R 的標準，在 SOL-1 的六個月時點，將近 80% 的病患無需救援治療。我們認為，考量到我們非常長的導入期（ramp）以及我們有兩次機會觀察病患是否有波動，那 20% 的病患在 SOL-R 中可能會被排除。

We expect an even higher rescue-free rate in SOL-R, and we believe that AXPAXLI is very well positioned to succeed in the non-inferiority SOL-R trial. Lisa, thank you again for your question. And again, a lot of those details will be addressed in the meeting in June in New York City, which I hope you will attend.

我們預期 SOL-R 的無需救援治療比率會更高，並且我們相信 AXPAXLI 在 SOL-R 的非劣性試驗中具備非常好的成功定位。Lisa，再次謝謝你的提問。而且，如我所說，其中許多細節會在 6 月於紐約市的會議中說明，我也希望你能出席。

Jon Wolleben, Citizens.

Jon Wolleben，Citizens。

Just wondering, Pravin, if you could talk a little bit about the feedback you received and how rental specialists plan on potentially integrating AXPAXLI in the practice based on SOL-1 and how that might change with the SOL-R readouts?

Pravin，我想請問你能否談談你們收到的回饋，以及視網膜專科醫師（retinal specialists）基於 SOL-1 的結果，可能會如何在臨床實務中整合 AXPAXLI？以及這在 SOL-R 讀出後可能會如何改變？

And that's the discussion going on right now. My colleagues expect to have this medicine in their hands, and the discussion that's going on right now is how will they be using it and how will they be introducing it to their patients, which is a great discussion to have.

而這正是目前正在進行的討論。我同事們預期很快就能把這款藥拿到手，而眼下的討論重點在於他們將如何使用它、以及如何把它介紹給病人；這是一個非常值得進行的討論。

I think ultimately, what I think, at least and this is just my hypothesis, is that this is the ideal drug to be every six-month fixed-dosing drug. And as I've said, to have a drug that lasts; that is a fixed-dosing, confident, every-six-month drug, one also has to be confident that that drug will last beyond six months, maybe 9 to 10 months in case the patient gets sick, the doctor is on vacation, that kind of thing. So this is the ideal drug for that.

我認為最終——至少以我的看法，這也只是我的假設——這會是最理想的每六個月固定給藥藥物。正如我所說，要有一款具備持久性、能夠讓人有信心採用每六個月固定給藥的藥物，也必須有信心它的效力能超過六個月，可能達到 9 到 10 個月，以防病人臨時生病、醫師休假之類的情況。因此，這就是最理想的藥物。

Now, how doctors will get to that fixed dosing is something that I think will be explored by the community. Some feel that they'll directly go to fixed dosing. I've had those discussions with my colleagues. Others feel that what they will initially do is to have a extended treatment plan that will continue to give them more and more confidence to go to that every six-month fixed dosing.

至於醫師會如何走到固定給藥這一步，我認為將由社群進一步探索。有些人覺得會直接採用固定給藥；我也和同事討論過。另一些人則認為，一開始會先採取延長治療計畫，藉此逐步建立更多信心，最後再過渡到每六個月固定給藥。

However they go there, I believe that that's where this drug will end up. And I think that will transform the way we treat patients with wet AMD. And in fact, I think that will align us with the rest of medicine.

不論他們如何走到那一步，我相信這就是這款藥最終會落腳的方式。我也認為這將改變我們治療濕性 AMD 病人的方式。事實上，我認為這也會讓我們與其他醫學領域的做法更一致。

I've always said that treat and extend, which is what we do now, is sort of opaque. If you ask your 10 KOLs what treat and extend means, you'll get 10 different answers. And there's really no study on treat and extend in a Phase 3 program.

我一直說，我們現在採用的「治療並延長」（treat and extend）其實有點不透明。你若去問 10 位 KOL「治療並延長」是什麼意思，你會得到 10 種不同答案。而且在第三期（Phase 3）計畫中，實際上並沒有針對「治療並延長」的研究。

Treat and extend is not on any label, and it certainly is not aligned with anything we do in medicine. You don't go to your cancer doctor and say, look, I'll wait until your bladder cancer comes back before I decide how often to see you.

「治療並延長」不在任何藥品標籤上，而且它當然也不符合我們在醫學上其他領域的做法。你不會去找腫瘤科醫師說：『等你的膀胱癌復發了，我再決定要多久回診一次。』

And you certainly don't go to your cardiologist who says, look, I'll wait for your first heart attack before I figure out how often to treat you. So this type of fixed dosing, I think, is aligned with medicine. I think there's good scientific data to support it. And I think that this drug is ideal for every six-month dosing.

你當然也不會去找心臟科醫師，而他說：『等你第一次心肌梗塞之後，我再來決定要多久治療你一次。』所以我認為這種固定給藥方式是符合醫學常規的。我認為也有良好的科學數據支持它。而我認為這款藥非常適合每六個月給藥一次。

The other important thing is that the adoptability, I think, will be very quick and it will be seamless. Nothing changes for the doctor. The workflow doesn't change. The experience doesn't change. It's a self-sealing 25-gauge needle.

另一個重要點是，我認為它的採用會非常快，而且會很順暢。對醫師而言沒有任何改變：工作流程不變、使用體驗不變。它是一支自我密封的 25 號針。

There's not a single new piece of equipment to buy. There's no added overhead. So I think the adoptability of this will be absolutely seamless. And I know that in talking to my colleagues, they are very enthusiastic to use this drug as soon as it's marketed.

完全不需要購買任何新的設備，也沒有額外的管理費用。因此我認為它的導入會非常無縫。我也知道，從我和同事的交流來看，他們都非常熱切希望在這款藥上市後盡快使用。

Yi Chen, H.C. Wainwright.

Yi Chen，H.C. Wainwright。

Pravin, could you comment on whether there are any patients who have dropped out of the SOL-1 trial and whether any patients from SOL-1 who are eligible to enroll into the SOL-X trial have chosen to do so? If not, what are their reasons for not enrolling into the SOL-X trial?

Pravin，你能否評論一下 SOL-1 試驗是否有任何病人退出？以及 SOL-1 中符合資格可納入 SOL-X 試驗的病人，是否有人選擇加入？如果沒有，他們不加入 SOL-X 試驗的原因是什麼？

We haven't given the actual numbers, but suffice it to say that the retention rate is absolutely remarkable. And I'll go so far as to say that the retention rate is probably better than any other retina Phase 3 study that we know of. This speaks to the enthusiasm not only of the patients, but also the doctors.

我們尚未公布實際數字，但可以說留存率非常驚人。我甚至可以說，這個留存率可能優於我們所知的任何其他視網膜第三期研究。這反映的不僅是病人的熱情，也包括醫師的熱情。

And historically, this is borne out, right? I go back to LUCENTIS and EYLEA, for instance. LUCENTIS had a seven-year head start. EYLEA came in seven years later and extended the durability by maybe a week or two and absolutely dominated the market. And you see the same kind of thing with VABYSMO now.

而且從歷史來看，這點也得到印證，對吧？例如回到 LUCENTIS 和 EYLEA。LUCENTIS 早了七年上市；EYLEA 在七年後進入市場，把持久性可能延長了一到兩週，卻徹底主導了市場。你現在也在 VABYSMO 身上看到類似的情況。

This is a real need in our community. Doctors know this. Patients know this. And seeing the data that they've seen with SOL-1 makes it very, very easy for patients and for doctors to stick with this program.

這是我們社群真正的需求。醫師知道，病人也知道。而看到他們在 SOL-1 所見到的數據後，病人與醫師都會非常、非常容易願意持續參與這個計畫。

So there's been an overwhelming amount of enthusiasm. We haven't given you the actual numbers, but again, the retention rate of this program, I'll go so far as to say, is higher than any other Phase 3 program that I know. And the enthusiasm is through the roof at this point.

所以大家的熱情非常高。我們沒有提供實際數字，但再次強調，這個計畫的留存率——我甚至可以說——高於我所知道的任何其他第三期計畫。而目前的熱度已經非常高。

(Operator Instructions) Lachlan Hanbury-Brown, William Blair.

（接線員指示）Lachlan Hanbury-Brown，William Blair。

Hi, Truman Dunkley on for Lachlan. I just wanted to ask. For the HELIOS-3 study, can you remind us if there's a certain proportion of patients that you will need to enroll with non-CIM DME to ensure that you have enough data to get DME in the label?

你好，我是代替 Lachlan 的 Truman Dunkley。我想請問：在 HELIOS-3 研究中，你能否提醒我們，是否需要納入一定比例的非 CIM DME 病人，以確保有足夠數據讓 DME 能寫入標籤？

No, there is no -- again, thank you for the question. Good morning. There is really no such requirement that we have guided you to. What I will say is we are very confident that we will not need to do another diabetic retinopathy study to cover all of diabetic retinal disease.

不，沒有——再次感謝你的提問。早安。我們並沒有向各位說明或設定這樣的要求。我想說的是，我們非常有信心不需要再做另一個糖尿病視網膜病變研究，就能涵蓋所有糖尿病視網膜疾病。

And I say that because, remember, what we're doing is enrolling patients with a moderate to severe non-proliferative diabetic retinopathy with non-central-involving diabetic macular edema with an ordinal endpoint, which captures every facet of change with non-proliferative diabetic retinopathy.

我之所以這麼說，是因為請記得，我們正在納入的是中度到重度的非增殖性糖尿病視網膜病變、合併非中央侵犯型糖尿病黃斑水腫的病人，並採用序位（ordinal）終點，能捕捉非增殖性糖尿病視網膜病變各個面向的變化。

Now, the FDA historically has given approval based on the disease as opposed to the clinical trial. We absolutely believe that we will have a label that will cover all of diabetic macular edema. And you've seen evidence for this over and over again.

此外，FDA 在歷史上通常是依疾病本身而非臨床試驗設計來核准適應症。我們完全相信，標籤將能涵蓋所有糖尿病黃斑水腫。你也一再看到這方面的證據。

If you go way back to ANCHOR and MARINA, for instance, there was a restriction in visual acuity in enrollment. And you see that for LUCENTIS. There is no restriction whatsoever. You look at PANORAMA, there is no restriction for a stage of non-proliferative diabetic retinopathy in the label.

例如回到更早的 ANCHOR 和 MARINA，入組時對視力有設限；但你看 LUCENTIS 的標籤，完全沒有這種限制。再看 PANORAMA，標籤上對非增殖性糖尿病視網膜病變的分期也沒有任何限制。

And most recently, my last company, in Iveric Bio, I recall that we didn't treat a single patient with centra-involving geographic atrophy. Yet if you look at the label for IZERVAY, it allows for all of geographic atrophy, foveal-involving and non-foveal-involving.

而最近，在我上一家公司 Iveric Bio，我記得我們沒有治療任何一位中央侵犯型地理性萎縮的病人；但如果你看 IZERVAY 的標籤，它允許用於所有地理性萎縮，包括侵犯中央凹與未侵犯中央凹。

And in the same way, we believe that with the label, eventually for AXPAXLI will cover all of diabetic macular edema, central involving and non-central involving. And also, recall that everybody with diabetic macular edema, everybody also has non-proliferative diabetic retinopathy.

同樣地，我們相信 AXPAXLI 最終的標籤將涵蓋所有糖尿病黃斑水腫，包括中央侵犯型與非中央侵犯型。另外也請記得，所有糖尿病黃斑水腫病人同時也都有非增殖性糖尿病視網膜病變。

So all of diabetes will be covered, we believe, by the label. Again I will add that, obviously, we haven't had labeling discussions with the FDA. It is far too early for that, but we firmly believe that this will be the only trial that will be necessary in the HELIOS programs for a broad label encompassing all of diabetic retinopathy.

因此我們相信，標籤將涵蓋所有糖尿病相關疾病。我也要補充，顯然我們尚未與 FDA 進行標籤討論，現在談這個還太早；但我們堅信，在 HELIOS 計畫中，這將是唯一必要的試驗，以取得涵蓋所有糖尿病視網膜病變的廣泛標籤。

Thank you. At this time, there are no further questions in queue, so this concludes our question-and-answer session. I will now turn the call back to Dr. Pravin Dugel for closing remarks.

謝謝。目前隊列中沒有其他問題，因此我們的問答環節到此結束。我現在把電話交回給 Pravin Dugel 醫師作結語。

Thank you. Once again, thank you all for joining us today, and thank you for your continued support. We hope you will join us on June 17 in New York City for our upcoming Investor Day. In the meantime, if you have any questions, please reach out to Bill Slattery, our Vice President of Investor Relations. Have a great day, everyone, and thank you.

謝謝。再次感謝各位今天加入我們，也謝謝各位持續的支持。我們希望各位能在 6 月 17 日於紐約市參加我們即將舉辦的投資人日。在此期間，如有任何問題，請聯繫我們投資人關係副總裁 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。感謝各位撥冗參與。各位現在可以掛線。