EyePoint Pharmaceuticals Inc (EYPT) 2025 Q1 法說會逐字稿

Good morning. My name is Tawanda, and I'll be your conference operator today. At this time, I would like to welcome everyone to the EyePoint first-quarter 2025 financial results and recent corporate developments conference call. There will be a question-and-answer session to follow at the completion of the prepared remarks. Please be advised that this call is being recorded at the company's request.

早安.我叫 Tawanda，今天我將擔任您的會議接線生。現在，我歡迎大家參加 EyePoint 2025 年第一季財務業績和近期公司發展電話會議。準備好的發言結束後，將有一個問答環節。請注意，應公司要求，本次通話正在錄音。

I would now like to turn the call over to George Elston, Executive Vice President and Chief Financial Officer of EyePoint. Sir, you may begin.

現在我想將電話轉給 EyePoint 執行副總裁兼財務長 George Elston。先生，您可以開始了。

Thank you, and thank you all for joining us on today's conference call to discuss EyePoint's first-quarter 2025 financial results and recent corporate developments. With me today is Dr. Jay Duker, President and Chief Executive Officer of EyePoint. Jay will begin with a review of recent corporate updates and discuss the ongoing clinical trials for DURAVYU. I will close with commentary on the first quarter 2025 financial results, and we will then open the call for your questions.

謝謝大家，也謝謝大家參加今天的電話會議，討論 EyePoint 2025 年第一季度的財務業績和最近的公司發展。今天與我一起的還有 EyePoint 總裁兼執行長 Jay Duker 博士。Jay 將首先回顧該公司最近的最新動態，並討論 DURAVYU 正在進行的臨床試驗。最後，我將對 2025 年第一季的財務表現進行評論，然後我們將開始回答您的問題。

Earlier this morning, we issued a press release detailing our financial results and recent corporate developments. A copy of the release can be found in the Investor Relations tab on the company website, www.eyepointpharma.com.

今天早些時候，我們發布了一份新聞稿，詳細介紹了我們的財務表現和最近的公司發展。新聞稿的副本可在公司網站 www.eyepointpharma.com 的「投資者關係」標籤中找到。

Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995.

在我們開始正式評論之前，我要提醒您，我們今天發表的各種言論均構成《1995 年私人證券訴訟改革法案》安全港條款規定的前瞻性陳述。

These include statements about our future expectations, clinical developments and regulatory matters, and time lines, the potential success of our products and product candidates, financial projections, and our plans and prospects.

這些包括關於我們未來預期、臨床發展和監管事項、時間表、我們的產品和產品候選物的潛在成功、財務預測以及我們的計劃和前景的聲明。

Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent annual report on Form 10-K, which is on file with the SEC and in other filings that we have made or may make with the SEC in the future.

由於各種重要因素，實際結果可能與這些前瞻性陳述所示的結果有重大差異，包括我們向美國證券交易委員會提交的最新 10-K 表年度報告中「風險因素」部分中討論的因素，以及我們已經或將來可能向美國證券交易委員會提交的其他文件中討論的因素。

Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.

任何前瞻性陳述僅代表我們截至今天的觀點。雖然我們可能選擇在未來某個時間點更新這些前瞻性陳述，但我們明確表示不承擔任何義務，即使我們的觀點改變。因此，您不應依賴這些前瞻性陳述來代表我們今天之後任何日期的觀點。

I'll now turn the call over to Dr. Jay Duker, President and Chief Executive Officer of EyePoint.

現在我將電話轉給 EyePoint 總裁兼執行長 Jay Duker 博士。

Thank you, George. Good morning, everyone, and thank you for joining us. We are proud to report yet another quarter of exceptional execution as we advance our lead program, DURAVYU, through late-stage clinical development.

謝謝你，喬治。大家早安，感謝大家的收看。我們很自豪地報告，隨著我們的主導項目 DURAVYU 進入後期臨床開發階段，我們又取得了另一個季度的出色執行。

Notably, we continue to receive strong positive feedback from both physicians and patients for our ongoing global Phase III trials, LUGANO and LUCIA for DURAVYU in wet age-related macular degeneration or wet-AMD, underscoring the impressive enrollment rate we are seeing. In fact, as we reported in this morning's press release, we have randomized over 90% of patients into the LUGANO trial and over 50% into the LUCIA trial.

值得注意的是，我們正在進行的全球 III 期試驗 LUGANO 和 LUCIA，針對 DURAVYU 治療濕性老年性黃斑部病變或濕性 AMD，持續收到來自醫生和患者的強烈積極反饋，這凸顯了我們所看到的令人印象深刻的入組率。事實上，正如我們在今天早上的新聞稿中所報導的，我們已將超過 90% 的患者隨機分配到 LUGANO 試驗，並將超過 50% 的患者隨機分配到 LUCIA 試驗。

This gives us great confidence that we will meet our time line to complete enrollment in the second half of 2025 and deepens our conviction that DURAVYU is on track to be the first-to-market of the current investigational sustained release treatments for wet AMD.

這給了我們很大的信心，我們將在 2025 年下半年按時完成患者招募，並更加堅定了我們的信念：DURAVYU 有望成為目前研究性濕性 AMD 緩釋治療藥物中第一個上市的藥物。

We believe this clinical momentum highlights the significant opportunity for DURAVYU as a differentiated treatment option in treating retinal disease. Our team is committed to our goal of delivering life-changing treatments to patients with severe retinal diseases, beginning with wet AMD. I want to take a moment to review why we believe DURAVYU is a best-in-class program and represents a compelling and strategically de-risked opportunity in wet AMD. First, DURAVYU is not another anti-VEGF program.

我們相信，這一臨床動能凸顯了 DURAVYU 作為治療視網膜疾病的差異化治療選擇的重要機會。我們的團隊致力於為患有嚴重視網膜疾病的患者提供改變生活的治療，首先是濕性 AMD。我想花點時間回顧為什麼我們認為 DURAVYU 是一流的項目，並且代表了濕性 AMD 領域一個引人注目且具有戰略風險的機會。首先，DURAVYU 不是另一種抗 VEGF 方案。

DURAVYU is a clinically validated, differentiated and potentially best-in-class sustained-release TKI. DURAVYU's receptor level inhibition of VEGF, blocking all isoforms of VEGF offers a broader and possibly more durable disease control compared to current ligand-blocking therapeutics.

DURAVYU 是一種經過臨床驗證、具有差異化且可能成為同類最佳的緩釋 TKI。DURAVYU 透過抑制 VEGF 受體水平，阻斷 VEGF 的所有亞型，與目前的配體阻斷療法相比，可提供更廣泛、更持久的疾病控制。

By also blocking PDGF receptors, DURAVYU may help reduce fibrosis, a key driver of long-term visual loss, which could further differentiate this potential wet AMD therapy. Next, DURAVYU's efficacy is supported by our Phase I and Phase II datasets, which are the most robust investigational datasets in wet AMD amongst all sustained delivery programs.

DURAVYU 還可以阻斷 PDGF 受體，有助於減少纖維化，這是長期視力喪失的關鍵驅動因素，這可以進一步區分這種潛在的濕性 AMD 療法。其次，DURAVYU 的療效得到了我們 I 期和 II 期資料集的支持，這些資料集是所有持續給藥計畫中濕性 AMD 領域最強大的研究資料集。

In our Phase II DAVIO 2 trial in wet AMD and a tough-to-treat population, approximately two-third of patients remained rescue-free for six months, and nearly half remained rescue-free for one-year with stable vision and anatomy from a single DURAVYU treatment.

在我們對濕性 AMD 和難治性患者群進行的 II 期 DAVIO 2 試驗中，大約三分之二的患者在接受一次 DURAVYU 治療後，六個月內無需進行搶救，近一半的患者在一年內無需進行搶救，視力和解剖結構保持穩定。

DURAVYU has established a very favorable safety profile with no DURAVYU-related ocular or systemic SAEs observed in over 190 patients evaluated across clinical trials for multiple indications. Additionally, there are also four FDA-approved products using our Durasert technology administered to tens of thousands of patients in real-world settings with a strong safety record.

DURAVYU 已建立起非常良好的安全性，在針對多種適應症的臨床試驗中評估的 190 多名患者中未觀察到與 DURAVYU 相關的眼部或全身性 SAE。此外，還有四種 FDA 批准的產品採用我們的 Durasert 技術，並在現實環境中為數以萬計的患者使用，具有良好的安全記錄。

Our Phase III non-inferiority program was developed in direct alignment with the FDA, follows recognized industry best practices, and is strategically designed to enhance the probability of both regulatory and commercial success.

我們的 III 期非劣效性計劃是與 FDA 直接合作制定的，遵循公認的行業最佳實踐，並且具有策略性設計，旨在提高監管和商業成功的可能性。

And finally, DURAVYU has the potential to address a large unmet need in an established and growing multi-billion-dollar market where patients are actively seeking safe, durable, longer-acting treatments. I want to also highlight our excitement around the potential for DURAVYU in diabetic macular edema or DME.

最後，DURAVYU 有潛力滿足成熟且不斷增長的數十億美元市場中的巨大未滿足需求，在這個市場中，患者正在積極尋求安全、持久、長效的治療方法。我還想強調一下我們對 DURAVYU 治療糖尿病性黃斑水腫或 DME 的潛力感到興奮。

While our company is currently focused on the execution of our wet AMD Phase III program, our recently reported positive 24-week Phase II results in DME further validates both the mechanism-of-action of vorolanib and the commercial potential of our Durasert E technology across multiple large retinal disease markets.

雖然我們公司目前專注於執行濕性 AMD 第三階段計劃，但我們最近報告的 DME 24 週第二階段積極結果進一步驗證了 vorolanib 的作用機制以及我們的 Durasert E 技術在多個大型視網膜疾病市場的商業潛力。

Turning to wet AMD, our goal in the Phase III trials is to demonstrate that DURAVYU can maintain stable vision and retinal anatomy for the majority of wet AMD patients with an every six-month dosing schedule. This would represent a significant improvement compared to the current anti-VEGF treatments in the US that are dosed on average every two months.

對於濕性 AMD，我們在 III 期試驗中的目標是證明 DURAVYU 可以透過每六個月一次的給藥計畫為大多數濕性 AMD 患者維持穩定的視力和視網膜解剖結構。與美國目前平均每兩個月進行一次的抗 VEGF 治療相比，這將是顯著的進步。

From a clinical perspective, this would provide patients and practitioners with the flexibility to reduce the number of visits without sacrificing visual outcomes and would ensure compliance over that six-month interval. Since initiating our Phase III trials, we've seen remarkable patient and physician interest, supporting the life-altering potential of DURAVYU.

從臨床角度來看，這將為患者和醫生提供靈活性，在不犧牲視力結果的情況下減少就診次數，並確保在六個月的時間間隔內遵守規定。自從啟動 III 期試驗以來，我們看到患者和醫生表現出極大的興趣，他們相信 DURAVYU 具有改變生活的潛力。

I'm pleased that both the LUGANO and LUCIA trials continue to meaningfully surpass our enrollment expectations with patient randomization in excess of 90% for the LUGANO trial and over 50% for the LUCIA trial. These enrollment rates significantly exceed those observed in comparable historic and other ongoing wet AMD trials, which we believe is driven by DURAVYU's robust clinical data package, including an outstanding safety profile and established efficacy demonstrated in the robust DAVIO 2 Phase II trial.

我很高興 LUGANO 和 LUCIA 試驗的入組率都繼續顯著超出我們的預期，其中 LUGANO 試驗的患者隨機化率超過 90%，LUCIA 試驗的患者隨機化率超過 50%。這些入組率大大超過了可比較的歷史和其他正在進行的濕性 AMD 試驗的入組率，我們認為這是由 DURAVYU 強大的臨床數據包推動的，包括出色的安全性和在強大的 DAVIO 2 II 期試驗中證明的既定療效。

This also highlights the significant need for more durable treatment options. The continued support and enthusiasm for DURAVYU from the retinal community not only reinforces our expected enrollment completion in both pivotal trials in the second half of this year, but also reaffirms our confidence in our derisked trial design.

這也凸顯了對更持久治療方案的迫切需求。視網膜界對 DURAVYU 的持續支持和熱情不僅增強了我們在今年下半年兩項關鍵試驗中完成招募的預期，也重申了我們對低風險試驗設計的信心。

Our global double-masked identical trials reflect a tried-and-true non-inferiority design used in the last four wet AMD drug approvals. There are several key reasons why we believe our well-powered, rigorously controlled program is structured to produce data that support approval and are meaningful for retinal specialists and patients.

我們的全球雙盲相同試驗反映了過去四次濕性 AMD 藥物批准中使用的經過驗證的非劣效性設計。我們相信，我們強大、控制嚴格的程序能夠產生支援批准並對視網膜專家和患者有意義的數據，這有幾個關鍵原因。

First, the LUGANO and LUCIA trials were specifically designed for regulatory and commercial success. Our trial design was informed by a robust Phase II trial and multiple FDA interactions with written agreement from the agency on our path to approval.

首先，LUGANO 和 LUCIA 試驗是專門為監管和商業成功而設計的。我們的試驗設計以嚴格的 II 期試驗和與 FDA 的多次互動以及該機構在我們獲得批准的過程中所達成的書面協議為基礎。

Second, our trials incorporate a fixed prespecified every six-month dosing for DURAVYU, a clean predictable design that mirrors intended real-world use and that provides a clear regulatory pathway. Learning from our Phase II supplemental injections are only permitted if a patient needs strict predefined criteria and are adjudicated in a masked manner to minimize variability and bias.

其次，我們的試驗採用了每六個月固定一次的預先指定的 DURAVYU 劑量，這是一種清晰可預測的設計，反映了預期的實際用途，並提供了清晰的監管途徑。只有當患者需要嚴格的預定標準並以掩蔽方式進行裁決以盡量減少變異性和偏見時，才允許從我們的 II 期補充注射中進行學習。

Our disciplined protocol is aimed at eliminating physician discretion in unnecessary supplemental treatments. Finally, the inclusion of both treatment-naive and previously treated patients enhances the broad applicability of our data and can support not just approval, but increased physician adoption and a potentially broader label.

我們嚴格的規程旨在消除醫生對不必要的補充治療的自由裁量權。最後，納入初治患者和先前接受過治療的患者增強了我們數據的廣泛適用性，不僅可以支持批准，還可以增加醫生的採用率和可能更廣泛的標籤。

As we continue to execute in the clinic, we are also laying the foundation for a potential commercial launch with our state-of-the-art GMP-compliant manufacturing facility in Northbridge, Massachusetts. Our facility is operational and will be capable of producing more than 1 million DURAVYU treatments annually to support expected global demand.

隨著我們繼續在臨床上執行，我們也正在利用位於馬薩諸塞州諾斯布里奇的最先進的符合 GMP 標準的製造工廠為潛在的商業發布奠定基礎。我們的工廠現已投入運營，每年將能夠生產超過 100 萬個 DURAVYU 治療產品，以滿足預期的全球需求。

Importantly, we are well-positioned with regard to potential tariff impacts as we also source our API from a US based manufacturer. Turning to our DME program, DURAVYU met the trial's primary and secondary endpoints for our Phase II VERONA trial, demonstrating compelling efficacy and durability results.

重要的是，由於我們的 API 也來自美國製造商，因此我們在應對潛在關稅影響方面處於有利地位。談到我們的 DME 計劃，DURAVYU 滿足了我們第二階段 VERONA 試驗的主要和次要終點，展示了令人信服的功效和持久性結果。

DURAVYU is the only sustained release TKI program with demonstrated activity and safety in DME. DME is the second-largest retinal disease indication, representing a $3 billion market opportunity by 2030. We believe DURAVYU is uniquely positioned to potentially extend the therapeutic dosing interval compared to currently available treatment options.

DURAVYU 是唯一在 DME 中被證實具有活性和安全性的緩釋 TKI 方案。DME 是第二大視網膜疾病適應症，到 2030 年市場規模將達到 30 億美元。我們相信，與目前可用的治療方案相比，DURAVYU 具有獨特的優勢，可延長治療給藥間隔。

To recap the VERONA results, both DURAVYU doses met the primary endpoint of longer time to first supplement versus the aflibercept control. DURAVYU 2.7 milligrams demonstrated an early, sustained and clinically meaningful improvement in best corrected visual acuity or BCVA with a gain of 7.1 letters compared to the baseline and a central subfield thickness or CST improvement of 76 microns on OCT measurement.

回顧 VERONA 的結果，兩種 DURAVYU 劑量均達到了主要終點，即與阿柏西普對照組相比，首次補充的時間更長。DURAVYU 2.7 毫克顯示出最佳矯正視力或 BCVA 的早期、持續和有臨床意義的改善，與基線相比增加了 7.1 個字母，並且 OCT 測量顯示中央子場厚度或 CST 改善了 76 微米。

This represented a 75% more drying effect versus the aflibercept control. Immediate bioavailability of the drug was demonstrated from the visual and anatomic gains observed as early as week four, and we're much more robust than those achieved in the aflibercept control eyes at this time point. A subset of unsupplemented patients further supported the robust results for the DURAVYU arms.

與阿柏西普對照組相比，乾燥效果提高了 75%。早在第四週就觀察到的視覺和解剖學增益證明了該藥物的即時生物利用度，並且比此時阿柏西普對照眼中實現的生物利用度要強得多。一組未接受補充治療的患者進一步支持了 DURAVYU 組的強勁結果。

These highly positive Phase II data will be critical in our planned engagement with the FDA this summer to solidify plans for a pivotal program. In summary, our identical pivotal Phase III LUGANO and LUCIA trials in wet AMD are exceeding expectations and remain on track to complete enrollment in the second half of this year with top-line data for both trials in the second half of 2026.

這些高度積極的 II 期數據對於我們今年夏天與 FDA 的合作至關重要，以鞏固關鍵項目的計劃。總而言之，我們在濕性 AMD 中進行的相同的關鍵性 III 期 LUGANO 和 LUCIA 試驗超出了預期，並預計在今年下半年完成招募，並在 2026 年下半年獲得兩項試驗的頂線數據。

The positive safety and efficacy data from the Phase II VERONA trial in DME further strengthens DURAVYU's profile as a potentially paradigm shifting treatment option and positions DURAVYU to become a potential multi-billion-dollar blockbuster franchise in the two largest retinal diseases.

DME 的 II 期 VERONA 試驗所獲得的積極的安全性和有效性數據進一步增強了 DURAVYU 作為潛在範式轉變治療方案的地位，並使 DURAVYU 有可能成為治療兩種最大視網膜疾病的、價值數十億美元的潛在重磅藥物。

Finally, thank you to the entire EyePoint team for another strong quarter and for your unwavering commitment to our collective goal of improving patients lives through better vision. Outside of our organization, it's been humbling to see such high levels of engagement from the patients and clinical investigators eager to participate in our ongoing trials.

最後，感謝整個 EyePoint 團隊又一個強勁的季度，並感謝你們對我們透過更好的視力改善患者生活的共同目標的堅定承諾。在我們的組織之外，看到患者和臨床研究人員如此熱切地參與我們正在進行的試驗，我們感到很榮幸。

We deeply appreciate your confidence in us, and we're proud to advance our therapeutics for the benefit of the entire retina community. With our best-in-class, sustained ocular delivery technology, and promising clinical pipeline across multiple blockbuster indications, we look forward to continued progress towards our upcoming milestones as the leader in sustained ocular drug delivery.

我們深深感謝您對我們的信任，我們很自豪能夠推進我們的治療方法，造福整個視網膜社區。憑藉我們一流的持續眼部輸送技術以及涵蓋多種重磅適應症的有前景的臨床管線，我們期待作為持續眼部藥物輸送領域的領導者，繼續朝著即將到來的里程碑邁進。

I will now turn the call over to George to review the financials. George?

我現在將把電話轉給喬治來審查財務狀況。喬治？

Thank you, Jay. To begin, we continue disciplined financial management and good stewardship of our resources, ending the first quarter with $318.2 million in cash and investments. We affirmed previous guidance and expect this cash will support our operations into 2027, beyond key data readouts from our Phase III LUGANO and LUCIA pivotal trials next year.

謝謝你，傑伊。首先，我們繼續嚴格財務管理並妥善管理我們的資源，第一季結束時我們擁有 3.182 億美元的現金和投資。我們確認了先前的指導，並預計這筆現金將支持我們到 2027 年的運營，超出明年我們第三階段 LUGANO 和 LUCIA 關鍵試驗的關鍵數據讀數。

As the financial results for the three months ended March 31, 2025 were included in the press release issued this morning, my comments today will be focused on a high-level review for the quarter. For the quarter ended March 31, 2025, total net revenue was $24.5 million compared to $11.7 million for the quarter ended March 31, 2024.

由於今天上午發布的新聞稿中包含了截至 2025 年 3 月 31 日的三個月的財務業績，因此我今天的評論將集中在本季度的高層審查上。截至 2025 年 3 月 31 日的季度，總淨收入為 2,450 萬美元，而截至 2024 年 3 月 31 日的季度為 1,170 萬美元。

Net product revenue for the quarter ended March 31, 2025, was $0.7 million, consistent with the quarter ended March 31, 2024. We expect net product revenue to continue at immaterial levels as we will no longer be supplying YUTIQ to ANI Pharmaceuticals, our US partner after May 31, 2025.

截至 2025 年 3 月 31 日的季度淨產品收入為 70 萬美元，與截至 2024 年 3 月 31 日的季度一致。我們預計淨產品收入將繼續保持在非實質水平，因為我們將在 2025 年 5 月 31 日之後不再向我們的美國合作夥伴 ANI Pharmaceuticals 供應 YUTIQ。

Consistent with our strategy, our manufacturing focus forward is on our DURAVYU program to support clinical trials, a potential NDA filing and future commercial launch. Net revenue from royalties and collaborations for the quarter ended March 31, 2025, totaled $23.7 million compared to $11 million in the corresponding period in 2024.

與我們的策略一致，我們未來的製造重點是 DURAVYU 計劃，以支援臨床試驗、潛在的 NDA 申請和未來的商業發布。截至 2025 年 3 月 31 日的季度，特許權使用費和合作淨收入總計 2,370 萬美元，而 2024 年同期為 1,100 萬美元。

The increase was primarily driven by recognition of remaining deferred revenue from the out-license of YUTIQ US rights in 2023. Operating expenses for the quarter ended March 31, 2025, totaled $73.3 million compared to $45 million in the prior year period. This increase was primarily driven by the ongoing LUGANO and LUCIA Phase III trials for DURAVYU in wet AMD, as enrollment is tracking ahead of expectations.

成長的主要原因是確認了 2023 年 YUTIQ 美國權利對外授權的剩餘遞延收入。截至 2025 年 3 月 31 日的季度營運費用總計 7,330 萬美元，而去年同期為 4,500 萬美元。這一增長主要得益於 DURAVYU 治療濕性 AMD 的 LUGANO 和 LUCIA III 期試驗的進行，因為患者入組情況超出了預期。

Net non-operating income totaled $3.6 million and net loss was $45.2 million or $0.65 per share compared to a net loss of $29.3 million or $0.55 per share for the prior year period. As I noted earlier, cash, cash equivalents and investments in marketable securities on March 31, 2025, totaled $318.2 million compared to $371 million as of December 31, 2024.

淨非營業收入總計 360 萬美元，淨虧損為 4,520 萬美元或每股 0.65 美元，而去年同期的淨虧損為 2,930 萬美元或每股 0.55 美元。正如我之前提到的，2025 年 3 月 31 日的現金、現金等價物和有價證券投資總額為 3.182 億美元，而 2024 年 12 月 31 日為 3.71 億美元。

In conclusion, we are incredibly pleased with EyePoint's progress so far in 2025 and remain well-capitalized to deliver DURAVYU Phase III data in 2026.

總而言之，我們對 EyePoint 在 2025 年迄今的進展感到非常滿意，並且仍有足夠的資金在 2026 年提供 DURAVYU 第三階段數據。

I will now turn the call back over to Jay for closing remarks.

現在我將把電話轉回給傑伊，請他作最後發言。

Thank you, George. As outlined this morning, we ended the first quarter in an excellent position and remain committed to advancing DURAVYU, a best-in-class program across multiple indications in retinal disease. We believe EyePoint represents a significant investment opportunity that is meaningfully derisked both clinically and financially.

謝謝你，喬治。正如今天早上所概述的，我們以優異的成績結束了第一季度，並將繼續致力於推進 DURAVYU，這是一項針對視網膜疾病多種適應症的最佳項目。我們相信 EyePoint 代表著一個重要的投資機會，無論從臨床角度或財務角度而言，其風險都顯著降低。

Our strong balance sheet will enable us to execute on our upcoming clinical milestones, which include, enrollment completion in the Phase III LUGANO and LUCIA trials in wet AMD expected in the second half of 2025; top-line data for these trials anticipated in 2026; and an end of Phase II meeting with the FDA around a pivotal trial in DME this summer. To close, 2025 is off to a great start for EyePoint.

我們強勁的資產負債表將使我們能夠實現即將到來的臨床里程碑，其中包括預計在 2025 年下半年完成濕性 AMD 的 III 期 LUGANO 和 LUCIA 試驗的入組工作；預計在 2026 年獲得這些試驗的頂線數據；以及今年夏天結束與 FDA 就 DME 的關鍵試驗舉行的 II 期會議。總而言之，2025 年對 EyePoint 來說是一個好的開始。

The progress we've achieved to date underscores our dedication to advancing our pipeline and delivering innovative treatments to improve the lives of patients suffering from serious retinal diseases. We're very excited to continue our momentum and look forward to providing additional updates in the coming quarters.

我們迄今所取得的進展凸顯了我們致力於推動產品線建設和提供創新治療方法以改善患有嚴重視網膜疾病的患者的生活。我們非常高興能夠繼續保持這種勢頭，並期待在未來幾季提供更多更新。

Thank you all very much for your attention this morning. I will now turn the call back over to the operator for your questions.

非常感謝大家今天早上的關注。現在我將把電話轉回給接線員以回答您的問題。

Thank you. (Operator Instructions)

謝謝。（操作員指示）

And before we start with the Q&A, I would like to reiterate a few points that we just made. At EyePoint, we're completely focused on the execution of our pivotal Phase III wet AMD trials, LUGANO and LUCIA, and the preparation for our NDA filing, which includes manufacturing of registration batches in our Northbridge, Massachusetts commercial facility.

在我們開始問答之前，我想重申一下我們剛才提出的幾點。在 EyePoint，我們完全專注於執行關鍵的 III 期濕性 AMD 試驗、LUGANO 和 LUCIA，以及準備提交 NDA，其中包括在我們位於馬薩諸塞州北橋的商業工廠生產註冊批次。

Based on our terrific Phase II DAVIO 2 data, the rapid enrollment in our Phase III trials and the continued clean safety profile for DURAVYU, we are confident in the value creation that successful LUGANO and LUCIA results will produce. With respect to strategy, we are focused on value creation for our current shareholders while advancing DURAVYU through Phase III trials. This means good stewardship of our cash while maximizing the value of DURAVYU.

基於我們出色的 II 期 DAVIO 2 數據、III 期試驗的快速招募以及 DURAVYU 持續清晰的安全性，我們對 LUGANO 和 LUCIA 的成功結果將產生的價值創造充滿信心。在策略方面，我們專注於為現有股東創造價值，同時推進 DURAVYU 的第三階段試驗。這意味著我們要妥善管理現金，同時最大限度地提高 DURAVYU 的價值。

We're now happy to take some questions.

我們現在很高興回答一些問題。

Jennifer Kim, Cantor.

珍妮佛金（Jennifer Kim），領唱。

Hi, good morning. Congrats on progress, and thanks for taking our question. Maybe to start off, I understand that you've reiterated guidance to complete Phase III enrollment in the second half of this year. But just looking at the pace of enrollment here, it seems like you guys are well on track to complete enrollment maybe earlier than investors appreciate. Am I thinking about this the right way or can you help us walk us through the math here?

嗨，早安。恭喜您取得進展，並感謝您回答我們的問題。首先，我了解到您重申了在今年下半年完成第三階段招生的指導意見。但僅從這裡的招生速度來看，似乎你們已經按計畫完成了招生，甚至可能比投資者預想的還要早。我這樣想對嗎？或者您能幫我們算一下這個數學題嗎？

Yeah, good morning, Jennifer, and thanks for the question. We are still guiding to full enrollment in both trials in the second half of this year. But yes, if you look at the public statements we've made around enrollment and kind of draw a line through the data points, we could certainly potentially have completion of enrollment in the first trial LUGANO in the second quarter of this year. That remains to be seen. You may know that the start of the LUCIA trial was approximately two months or so after LUGANO, and we would expect that the LUCIA results will come in approximately two months after LUGANO as well.

是的，早安，詹妮弗，謝謝你的提問。我們仍在指導今年下半年這兩項試驗實現全面招生。但是的，如果你看一下我們在招生方面所發表的公開聲明，並透過數據點畫一條線，我們肯定有可能在今年第二季完成第一次試驗盧加諾的招生。這還有待觀察。您可能知道，LUCIA 試驗是在 LUGANO 之後大約兩個月開始的，我們預計 LUCIA 的結果也會在 LUGANO 之後大約兩個月出來。

Okay, that's helpful. And if I could sneak in one more question, just this DME underappreciated opportunity. Can you just remind us what you're looking for in your upcoming meeting with the FDA and just some comments on I guess, timing and potential outcomes? Thanks.

好的，這很有幫助。如果我可以再偷偷問一個問題的話，那就是這個 DME 被低估的機會。您能否提醒我們一下，您在即將與 FDA 舉行的會議中期待什麼，以及對時間和潛在結果的一些評論？謝謝。

Sure. We have our Chief Medical Officer, Ramiro Ribeiro, on the line also. Ramiro, do you want to talk a little bit about the upcoming end of Phase II meeting with the FDA over DME?

當然。我們的首席醫療官拉米羅·裡貝羅 (Ramiro Ribeiro) 也在線。拉米羅，您想談談即將結束的與 FDA 就 DME 舉行的 II 期會議嗎？

Sure. Hey Jennifer. So we are going to be proposing a clinical plan in our Phase III study that brings efficiency to our program. So we are going to propose one single study comparing our drug to standard-of-care, and the primary endpoint is going to be as expected for DME trial BCVA. We're planning to have the meeting with the FDA soon, as Jay mentioned, and we have that by the summer.

當然。嘿，珍妮佛。因此，我們將在第三階段研究中提出一項臨床計劃，以提高我們專案的效率。因此，我們將提出一項單獨的研究，將我們的藥物與標準治療進行比較，主要終點將與 DME 試驗 BCVA 的預期一致。正如傑伊所提到的，我們計劃很快與 FDA 舉行會議，預計在夏天舉行。

Okay, thanks again, guys.

好的，再次感謝大家。

Tess Romero, JPMorgan.

摩根大通的泰絲·羅梅羅。

Hey Jay and team, thanks so much for taking our questions this morning. A big picture, so what do you attribute the rapid pace of enrollment here in your Phase III wet AMD trials? Anything anecdotally, you can tell us on what you are hearing from your clinical sites? And secondly, where are you most focused in terms of clinical trial execution in terms of mitigating any risks? Thanks so much.

嘿，傑伊和團隊，非常感謝你們今天早上回答我們的問題。整體來說，那麼您認為 III 期濕性 AMD 試驗中招募人數如此之快的原因是什麼？您能告訴我們您從臨床站點聽到的任何趣聞嗎？其次，在臨床試驗執行方面，您最關注哪些方面以減輕風險？非常感謝。

Terrific questions, Tess. Thank you very much for them. And again, I'm going to attribute most of our success in the rapid enrollment to Ramiro and his team. And I'm going to let him, again, answer that question on why it is that we're rapidly enrolling, as well as what he and his team are focusing on to make sure our results are sound.

很棒的問題，苔絲。非常感謝他們。我再次將我們快速招生的成功歸功於拉米羅和他的團隊。我將再次讓他回答這個問題，為什麼我們要快速招生，以及他和他的團隊將重點關注什麼以確保我們的結果合理。

Yes. Tess, thanks for the question. So I think the number one feedback we get from investigators is that our study is patient-centric, is easy to follow, and the robust data that we have from Phase II study as well as our Phase I program give them confidence when they are discussing to patient and potentially offering participation in the study.

是的。苔絲，謝謝你的提問。因此，我認為我們從研究人員那裡得到的第一個回饋是，我們的研究以患者為中心，易於遵循，我們從 II 期研究以及 I 期計劃中獲得的可靠數據讓他們在與患者討論並可能參與研究時充滿信心。

Of course, we do a lot of things to make the study easy for sites and patients, but the most important part is the robust data that we have that gives confidence to investigators and patients. I think we are doing an excellent job identifying any potential risk in our Phase III program on the conduct of this study. So we look at all areas to ensure the integrity of the data is pristine, so that it can be efficient on our NDA submission.

當然，我們做了很多事情來讓研究地點和患者輕鬆地進行研究，但最重要的是我們擁有的可靠數據，這給研究人員和患者帶來了信心。我認為我們在識別研究的第三階段計劃中的任何潛在風險方面做得非常出色。因此，我們會審查所有領域以確保資料的完整性，以便能夠有效地提交 NDA。

Thank you.

謝謝。

Tyler Van Buren, TD Cowen.

泰勒範布倫 (Tyler Van Buren)，TD Cowen。

Hey guys, good morning. The enrollment progress is very, very impressive. So with the increased time lines to enrollment completion in the LUGANO and LUCIA trials, does it make sense to potentially run a small Phase II study in RVO considering that is a significant additional opportunity in part of the market beyond wet AMD and DME? Is there any way that you could do this in a cost-efficient manner as we wait for the Phase III data?

大家好，早安。入學進度非常令人印象深刻。因此，隨著 LUGANO 和 LUCIA 試驗的入組完成時間線的增加，考慮到這是除濕性 AMD 和 DME 之外的部分市場的一個重要的額外機會，在 RVO 中進行一項小規模的 II 期研究是否有意義？在等待第三階段數據時，有沒有什麼方法可以以經濟高效的方式做到這一點？

Yeah, hi Tyler, thanks for the question. And it is really something that we've thought about really more in the long term of how we can create more value around DURAVYU and what are the other potential add on indications. RVO is certainly one of them.

是的，嗨，泰勒，謝謝你的提問。我們確實進行了更深入的長期思考，即如何圍繞 DURAVYU 創造更多價值，以及其他潛在的附加適應症。RVO 肯定是其中之一。

But as I stated in my comments, we are really focused on wet AMD right now and on our cash runway after data. And so the value that we would get at this point from an RVO trial probably is not something that would or suggest to us that it's a pathway we would take right now.

但正如我在評論中所說，我們現在真正關注的是濕性 AMD 以及數據公佈後的現金流。因此，我們現在從 RVO 試驗中獲得的價值可能並不是表明我們現在會採取這種途徑的東西。

With the anticipation of in the hope of good data great data from our Phase III program, I'm sure you'll see expansion into other areas for which DURAVYU might be beneficial such as RVO. And I think there are some areas which you could certainly think about other expansion of the market too.

我們希望從我們的第三階段計劃中獲得優質數據，我相信您會看到 DURAVYU 擴展到可能有益的其他領域，例如 RVO。我認為您也可以考慮在某些領域擴大市場。

For example, we think with a growing number of high myopes in the world that myopic choroidal neovascularization would be another area that DURAVYU would do very well in. So yes, this is part of the longer-term program, but I don't think we're going to see it in the short-term.

例如，我們認為，隨著世界上高度近視患者數量的不斷增加，近視脈絡膜新生血管將是 DURAVYU 表現非常出色的另一個領域。是的，這是長期計劃的一部分，但我認為我們不會在短期內看到它。

Yatin Suneja, Guggenheim.

古根漢美術館的亞廷·蘇內賈（Yatin Suneja）。

Thank you for taking my question. Maybe just a quick one form me, are you able to comment on the screen failure rate for both studies? Also, the type of patient or the mix of patient naive versus VEGF-exposed patients that you are able to enroll? And anything you are able to comment on the safety side, at least on the blinded basis, given that one study is almost complete from an enrollment perspective? Thank you.

感謝您回答我的問題。我只是想快速問一下，您能否評論一下這兩項研究的篩選失敗率？此外，您可以招募哪些類型的患者，或是未接受過 VEGF 治療的患者和接受過 VEGF 治療的患者的組合？鑑於從招募角度來看一項研究已接近完成，您能否對安全性方面（至少在盲法基礎上）發表任何評論？謝謝。

Thank you, Yatin, and nice to hear from you again. With respect to screen failure rates, what I can say is historically, screen failure rates in wet AMD are approximately 50%. And we're doing a little bit better than that in both trials. And there's always some learning. The screen failure rates at the beginning of the trial tend to be a little higher.

謝謝你，Yatin，很高興再次收到你的來信。關於螢幕故障率，我可以說的是，從歷史上看，濕性 AMD 的螢幕故障率約為 50%。我們在兩次試驗中都取得了更好的成績。並且總是有一些學習。試用初期的螢幕故障率往往會稍高一些。

And as the doctors understand exactly what type of patient meets the criteria, the screen failure rates do go down, and we're seeing that in both trials. With respect to the mix of naive versus previously treated, we're going for approximately 75% naive, 25% previously treated. And given the reality that previously treated patients are already in the doctor's practices and can be identified ahead of time, we anticipated at the beginning of both trials, most of the enrolled patients would be previously treated and that's in fact what we saw.

當醫生確切了解哪種類型的患者符合標準時，篩檢失敗率就會下降，我們在兩次試驗中都看到了這一點。對於未治療患者和接受過治療的患者的比例，我們預計大約 75％ 為未治療患者，25％ 為接受過治療患者。鑑於先前接受過治療的患者已經在醫生的診所接受治療並且可以提前確定，我們在兩項試驗開始時就預計，大多數入組患者之前都會接受過治療，事實上我們也看到了這種情況。

And early on in both trials, we capped the number of patients who were previously treated, we capped the enrollments. So that from now, in both trials we're just recruiting naive patients and this is again to be expected. What we've been very surprised about is, we expected that the rapid enrollment seen early on with the allowance of previously treated patients would slow down once we capped them and we didn't see that.

在這兩項試驗的早期，我們都限制了先前接受治療的患者數量，也限制了入組人數。因此從現在開始，在這兩項試驗中我們都只是招募初次接受治療的患者，這也是意料之中的事。讓我們感到非常驚訝的是，我們原本預計，在允許接受過治療的患者入組的情況下，早期出現的快速入組速度會在我們限制入組人數後減慢，但我們並沒有看到這種情況。

What's been remarkable is that in both trials, the enrollment rates have been very high and very steady. As for release of masks -- masked data, we really aren't thinking about doing that right now. I think we might do that in the future. Certainly, things like masked data around demographics of the patients would not be something that would compromise the registrational trials by introducing any operational bias or the ability to have a well-controlled trial.

值得注意的是，在這兩次試驗中，入學率都非常高且非常穩定。至於發布屏蔽數據，我們現在確實沒有考慮這樣做。我想我們將來可能會這樣做。當然，諸如掩蓋患者人口統計數據之類的事情不會因引入任何操作偏見或影響進行良好控制的試驗的能力而損害註冊試驗。

But we're certainly not going to disclose things piecemeal and we're certainly not going to disclose any masked Phase III results just because of the risk of compromising the data and introducing operational bias. So with respect to safety, what I can say generally is that based on our public statements prior, the safety of DURAVYU has been very, very good.

但我們絕對不會零零碎碎地披露信息，也絕對不會僅僅因為存在洩露數據和引入操作偏差的風險而披露任何掩蓋的第三階段結果。因此，關於安全性，我可以概括地說，根據我們先前的公開聲明，DURAVYU 的安全性非常非常好。

Excellent, thank you.

非常好，謝謝。

Kambiz Yazdi, Jefferies.

坎比茲·亞茲迪（Kambiz Yazdi），傑富瑞（Jefferies）。

Okay, thank you so much for the questions. A couple from me. How should we model R&D going forward? And then separately, I was curious if you'd be so kind of to provide your perspective on how biosimilars are shaping the wet AMD market. Would you consider biosimilar aflibercept loading in a post marketing study for DURAVYU? It's obviously not at all a focus for you right now but I'm curious on your perspective if there could be any value in exploring that. Thank you.

好的，非常感謝您的提問。這是我的一些。我們該如何規劃未來的研發？另外，我很好奇您是否願意提供您對生物相似藥如何影響濕性 AMD 市場的看法。您會考慮在 DURAVYU 上市後研究中加入生物相似藥阿柏西普嗎？顯然這根本不是您現在關注的重點，但我很好奇您的觀點，探索這一點是否有任何價值。謝謝。

Thanks, Kambiz Appreciate the questions. Let me take the second one first, and then I'll ask George to comment on R&D costs going forward. First of all, we're agnostic to the biosimilar market, whether a doctor -- if and when we get approval with an every six-month dosing interval, what the doctor chooses to load with before the use of DURAVYU, we're really agnostic to that. We have no reason to believe that a biosimilar, aflibercept, would behave any differently than on-label aflibercept.

謝謝，Kambiz 感謝您的提問。我先回答第二個問題，然後我會請喬治對未來的研發成本發表評論。首先，我們對生物相似藥市場持不可知論，無論是醫生——如果我們獲得每六個月給藥間隔的批准，醫生在使用 DURAVYU 之前選擇使用什麼藥物，我們對此確實持不可知論。我們沒有理由相信生物相似藥阿柏西普的作用會與標籤上的阿柏西普有任何不同。

The rest of it, with respect to any other loading of any anti-VEGF, whether it's off-label Avastin, Lucentis, VABYSMO, the three monthly doses, you wouldn't expect a patient to respond any differently to any of them over those first three months.

其餘部分，對於任何其他抗 VEGF 藥物，無論是未列入說明書的 Avastin、Lucentis 還是 VABYSMO，三個月的劑量，您都不會期望患者在前三個月對它們中的任何一種藥物產生任何不同的反應。

So, if you look at all of the curves of all the approved drugs and look at the first three months, they're really quite similar in their visual acuity improvement and the OCT improvement. So as a general rule, we wouldn't think the choice of a ligand-blocker for the load would make any difference. George, do you want to go ahead and talk about anticipated R&D costs?

因此，如果您查看所有核准藥物的所有曲線並查看前三個月，它們在視力改善和 OCT 改善方面確實非常相似。因此，作為一般規則，我們認為選擇負載的配體阻斷劑不會產生任何影響。喬治，你想繼續談預期的研發成本嗎？

Sure. And Kambiz, thanks for the question. As I noted on the call, our R&D burn is up year-over-year, but that's really driven by the exceptional recruitment we've seen. And our -- part two of that is our cash guidance is unchanged. So, if you think about R&D in 2025, your prior year or your current model is probably correct for the full year, but we just spent more in Q1 because the trials are going so well.

當然。Kambiz，謝謝你的提問。正如我在電話中提到的，我們的研發投入逐年增加，但這實際上是由於我們看到的出色招募所致。我們的第二部分是我們的現金指導保持不變。因此，如果您考慮 2025 年的研發，那麼您前一年或當前模型可能適用於全年，但我們在第一季花費了更多，因為試驗進展順利。

So I think full year is probably the same, just moved some of that burn you may have in Q2 and Q3 up a little bit.

所以我認為全年可能是一樣的，只是將第二季和第三季可能出現的損失稍微上調了一些。

Great. Thank you so much.

偉大的。太感謝了。

Graig Suvannavejh, Mizuho.

瑞穗的 Graig Suvannavejh。

Hi, this is Sam on for Greg. Thanks for taking the questions. Maybe a couple from me. Has the recent shortages at co-pay assistant programs that we've been hearing from retinal disease companies impacting the enrollment in your studies in any way? And also, as it relates to enrollment, can you point to anything specific in terms of trial design or differentiating factors that one would choose enrolling in your studies versus that of your competitors? Thank you.

大家好，我是 Sam，代表 Greg。感謝您回答這些問題。也許我有幾個。我們從視網膜疾病公司聽說，最近共同支付助理計畫出現短缺，這是否會對您的研究入學率產生影響？此外，就招生而言，您能否在試驗設計或差異化因素方面指出一些具體因素，讓人們選擇參加您的研究而不是競爭對手的研究？謝謝。

Thanks for the question, Sam. And they are good timing of the questions and really topical. So that co-pay assistance program that Sam mentioned is called the Good Days program, and it was funded to allow for copays for patients who were not totally covered for their branded either wet AMD drug or a GA drug.

謝謝你的提問，山姆。他們提問的時機把握得很好，而且非常切題。因此，Sam 提到的共同支付援助計劃被稱為「美好日子」計劃，該計劃的資金用於為那些沒有完全覆蓋其品牌濕性 AMD 藥物或 GA 藥物的患者提供共同支付。

For reasons that I'm not sure have been totally made public, but the companies that have funded Good Days in the past chose not to fund it so far in 2025. What this means is that patients who have the onset of wet AMD and do not have secondary coverage or coverage for the co-pays and want to be treated with a branded drug could have significant out-of-pocket costs.

由於一些我不確定是否完全公開的原因，但過去資助過 Good Days 的公司選擇在 2025 年之前不為其提供資金。這意味著，患有濕性 AMD 且沒有二級保險或共同支付保險的患者如果想要接受品牌藥物治療，可能會產生大量的自付費用。

We expect that this is helping our enrollment because, obviously, we would offer no charge the drugs in our study. So that the lack of the Good Days program, I'm sure is lifting all boats here, and I would expect that all of the wet AMD trials would benefit from that. As for specifics around why doctors are choosing our trial, we believe first to a large degree, again, I'd like to defer to Ramiro about anything specific that his interactions with our investigators and the investigational sites are telling him about this.

我們預計這將有助於我們的招募，因為顯然我們會免費提供研究中的藥物。因此，我確信，缺少 Good Days 計劃會讓所有人都受益，並且我希望所有濕式 AMD 試驗都會從中受益。至於醫生選擇我們試驗的具體原因，我們認為，首先，在很大程度上，我想再次向拉米羅詢問他與我們的研究人員和研究地點的互動中了解到的任何具體信息。

Yeah, thanks for the question, Sam. As I mentioned, the number one feedback we get from site is the fact that we have run a robust large Phase II study and that provides them confidence on the efficacy data, but most important, on the safety data, that gives them comfort on offering this study to a patient, knowing that we have dosed over 190 patients with DURAVYU.

是的，謝謝你的提問，山姆。正如我所提到的，我們從現場獲得的第一個回饋是，我們已經進行了一項強大的大型 II 期研究，這讓他們對療效數據充滿信心，但最重要的是，對安全性數據充滿信心，這讓他們放心地將這項研究提供給患者，因為他們知道我們已經為超過 190 名患者使用了 DURAVYU。

And then after that, things like being a study that is very patient-centric, so every patient is treated in this study either with aflibercept or with our investigational drug, how easy it is to conduct the study. It's not to burden to patients and physicians, and great support that EyePoint is providing to sites via our clinical operations team as well as our medical affairs team.

然後，由於這是一項以患者為中心的研究，因此研究中的每位患者都會接受阿柏西普或我們的研究藥物的治療，因此進行研究非常容易。這不會給患者和醫生帶來負擔，而且 EyePoint 透過我們的臨床營運團隊和醫療事務團隊為各站點提供了大力支持。

Nick Quartapella, Baird.

尼克·誇塔佩拉，貝爾德。

Hey everyone, This is Nick on for Colleen. Thanks for taking your question, and congrats on progress again. I just want to get a little more color on how the FDA views the impact of rescues on the primary endpoint for wet AMD. So I was wondering if there's a number on how many rescues are allowed, and is there a certain window where rescues are not allowed, for example, within a number of weeks before -- within the primary endpoint?

大家好，我是尼克，代表科琳。感謝您的提問，並再次祝賀您取得進展。我只是想進一步了解 FDA 如何看待救援對濕性 AMD 主要終點的影響。所以我想知道是否允許進行多少次救援，以及是否存在不允許進行救援的特定時間段，例如在主要終點之前的幾週內？

Thanks for the questions, Nick. First of all, our interactions with the FDA around rescues have been consistent. They have not had any of the interactions either at our Type-C meeting in 2022 or the end-of-Phase II meeting in 2024 suggested that there was a number of rescues by which a patient would be eliminated from the trial per se. What does that mean? Well, this is an intent-to-treat study that the top-line data will be from all patients.

謝謝你的提問，尼克。首先，我們與 FDA 在救援方面的互動一直是一致的。無論是在我們 2022 年的 C 類會議還是 2024 年的 II 期末會議上，他們都沒有進行任何互動，表明存在一些可以將患者從試驗中淘汰的救援措施。這意味著什麼？嗯，這是一項意向性治療研究，其頂線數據來自所有患者。

And then sensitivity analysis will be applied to the patients who got supplemented or rescued. And remember, in our trial, the control of aflibercept arm can also be rescued. So, there will be also a calculation of the rescues compared in each arm. With respect to timing of rescues, that was not something that was ever brought up at either of our meetings and there's nothing in writing that we've received from the FDA about waiting the timing of a rescue or that a patient who got rescued at a certain point of the study would be eliminated from the study. That's not something that the FDA has brought up with us.

然後對補充或挽救的患者進行敏感性分析。請記住，在我們的試驗中，阿柏西普組的控制也可以被挽救。因此，也將對每個組別的救援情況進行計算比較。關於救援時間，我們兩次會議都沒有提出過這個問題，而且 FDA 也沒有給我們任何書面文件，說明等待救援時間或在研究的某個時間點獲救的患者將被淘汰出研究。這不是 FDA 向我們提出的問題。

Great. Thank you.

偉大的。謝謝。

Deb Chatterjee, Jones.

黛布·查特吉，瓊斯。

Hi, thanks for taking my question. So I have another follow-up on the biosimilars. So based on your KOL interactions, especially, let's say, at ARVO to what extent do you see Amgen's PAVBLU impacting the wet AMD commercial landscape? And maybe could you comment on the potential for price erosion and any implications for DURAVYU?

你好，謝謝你回答我的問題。因此，我對生物相似藥還有另一個後續關注。那麼，根據您與 KOL 的互動，尤其是在 ARVO，您認為安進的 PAVBLU 對濕性 AMD 商業格局的影響程度如何？您能否評論一下價格下跌的可能性以及對 DURAVYU 的影響？

Well thanks for the question and there's something obviously that we've been thinking about and projecting. It it's hard for me to answer the question about how the biosimilars will impact the market in general.

嗯，謝謝你的提問，顯然我們一直在思考和預測一些事情。我很難回答生物相似藥將如何影響整個市場的問題。

It's hard for me to answer the question about how the biosimilars will impact the market in general. Once again, with respect to DURAVYU, we don't believe they'll have any impact on DURAVYU's acceptance because we're a different MOA, different target, and we last six months or longer with a single injection, something that none of the biosimilars can do. Right now, the last data I saw was, the biosimilar market was still quite small in the United States.

我很難回答生物相似藥將如何影響整個市場的問題。再次強調，關於 DURAVYU，我們認為它們不會對 DURAVYU 的接受度產生任何影響，因為我們採用不同的藥物作用機制 (MOA)，不同的目標，並且一次注射就能維持六個月或更長時間，這是任何生物仿製藥都無法做到的。目前，我看到的最新數據是，美國的生物相似藥市場仍然很小。

I think it's running about 5% of the usage, and much of it again is driven by economics, economics either to the payer or to the physician practice. So I think in order to try to project out how biosimilars are going to be adopted, I think you have to take a look at the economics of them, and that's just a general statement that really again has nothing in particular to do with our drug. Pricing is something that we're thinking about and that we're working through.

我認為它的使用率約為 5%，其中很大一部分又是由經濟因素驅動的，無論是對於付款人還是對醫生而言都是經濟因素。因此，我認為，為了嘗試預測生物相似藥將如何被採用，我認為你必須看看它們的經濟性，這只是一個一般性的說法，實際上與我們的藥物沒有什麼特別的關係。我們正在考慮並努力解決定價問題。

And again, George, if you want to make a comment at a high level how we're viewing pricing and whether we think biosimilars will impact that at all, happy to have you comment.

喬治，如果你想從高層次評論我們如何看待定價，以及我們是否認為生物相似藥會對此產生影響，我很高興聽到你的評論。

Yeah, and thank you for those questions. I think going back to what Jay said during the call is, DURAVYU is not another anti-VEGF. And as you -- as our team thinks about approaching it in the marketplace, we're bringing something very different. We're not another ligand-blocker.

是的，謝謝你提出這些問題。我認為回到傑伊在通話中所說的話，DURAVYU 不是另一種抗 VEGF 藥物。當我們的團隊考慮將其推向市場時，我們會帶來一些非常不同的東西。我們不是另一種配體阻斷劑。

We're bringing sustained delivery, new MOA, and that's going to be very important part of our negotiation, not just with FDA, but ultimately with payers. And so just broadly speaking, as we -- and if you look at the trial design for DURAVYU, one, DURAVYU replaces three anti-VEGFs. And so as you think about your pricing models, that's a good place to start.

我們帶來了持續交付和新的 MOA，這將是我們談判中非常重要的一部分，不僅與 FDA，而且最終與付款人。因此，從廣義上講，如果您看一下 DURAVYU 的試驗設計，您會發現，DURAVYU 取代了三種抗 VEGF。因此，當您考慮定價模型時，這是一個很好的起點。

Okay great. That's very helpful thank you.

好的，太好了。這非常有幫助，謝謝。

Greg Harrison, Scotiabank.

加拿大豐業銀行的格雷格·哈里森。

Good morning everyone. Thank you for taking our question. This is Joe on for Greg. I'm just thinking to the future a little bit here, assuming LUGANO and LUCIA will read out at different rates, is there potential for a rolling NDA submission, and how might that impact your top-line data release strategy in the second half of '26? Thank you.

大家早安。感謝您回答我們的問題。這是喬，代替格雷格。我只是在這裡稍微思考了一下未來，假設 LUGANO 和 LUCIA 將以不同的速率宣讀，是否有可能滾動提交 NDA，以及這將如何影響您在 26 年下半年的頂級數據發布策略？謝謝。

Thanks for the questions, Joe. The NDA submission is really the rate-limiting step is last visit, last patient in of the second trial, in our case, the LUCIA trial. From a rolling perspective, there is an internal rolling that we're doing already, which is preparing the various documents in the various sections that we already have and we will fully expect to just as the data comes in from the two trials drop the data into the documents so that we can shorten the time between last patient in top-line results and actual NDA submission.

謝謝你的提問，喬。 NDA 提交實際上是一個限速步驟，即第二次試驗（在我們這個例子中是 LUCIA 試驗）的最後一次訪視，也就是最後一位患者。從滾動的角度來看，我們已經在進行內部滾動，即準備我們已經擁有的各個部分中的各種文檔，並且我們完全希望在從兩個試驗中獲得數據時將數據放入文檔中，以便我們能夠縮短最後一位患者的頂線結果和實際提交 NDA 之間的時間。

Ramiro, again, is really deep into this, and I will ask him to make any other comments about steps that we're taking to minimize that time between last patient, last visit and submission.

再次，拉米羅對此進行了深入研究，我將請他對我們正在採取的措施發表任何其他評論，以盡量減少最後一位患者、最後一次就診和提交報告之間的時間。

Thanks, Jay. So as Jay mentioned, the limitation factor for the full submission is going to be the last patient on the second study. However, since LUGANO is enrolling quite faster, we might have a good opportunity to accelerate things, especially interpretation of the results on the first study. And because the two studies are so similar that would certainly bring efficiency when we are doing things for the second study, meaning that there's a lot of analysis, interpretation, writing that needs to happen and if we do that for the first study, again, because the second study is identical, we'll certainly bring efficiency when we do that again for the second study.

謝謝，傑伊。正如傑伊所提到的，完整提交的限制因素將是第二項研究的最後一名患者。然而，由於盧加諾的招生速度相當快，我們可能有很好的機會來加速這一進程，特別是對第一項研究結果的解釋。而且因為這兩項研究非常相似，所以當我們進行第二項研究時，肯定會提高效率，這意味著需要進行大量的分析、解釋和寫作，如果我們對第一項研究也這樣做，那麼由於第二項研究是相同的，當我們再次對第二項研究這樣做時，肯定會提高效率。

That's great. Thank you so much.

那太棒了。太感謝了。

Yale Jen, Laidlaw & Company.

耶魯仁萊德勞公司。

Thanks for taking the questions. Just actually a follow up on the previous one, to get some colors, which is when you do the data release next years, would that two data, would that be sort of two -- roughly two months apart for each of those or you have other plans?

感謝您回答這些問題。實際上只是對上一個問題的跟進，以獲得一些顏色，也就是當您明年發布數據時，那兩個數據，那會是兩個 - 大約相隔兩個月，還是您有其他計劃？

Good morning, Yale, thanks for the question. Well, approximately two months, I think is likely. We'll know obviously when that last patient is enrolled in the first trial, and then the last patient is enrolled in the second trial, the mathematics will be pretty easy at that point.

早安，耶魯，謝謝你的提問。嗯，我認為大概兩個月吧。我們顯然會知道，當最後一名患者參加第一次試驗時，然後最後一名患者參加第二次試驗時，那時的數學計算就會非常簡單。

Our plan, because we do expect them to be separated by several months is that we will release the data as the data becomes available in each trial. But again, we anticipate it will be approximately two months apart based on the study start and based on the similar enrollment patterns, that we're seeing in both trials.

我們的計劃是，因為我們確實預計它們會相隔幾個月，所以我們會在每次試驗中獲得數據時發布數據。但是，根據研究開始的時間以及我們在兩次試驗中看到的相似的招生模式，我們預計這將相隔約兩個月。

Okay, great, thanks and congrats on the rapid enrollment.

好的，太好了，謝謝，恭喜你快速入學。

Yi Chen, H.C. Wainwright.

陳毅，H.C.溫賴特。

Good morning. This is Eduardo on for Yi. Thanks for taking the question. I had a question regarding the baseline patient characteristics in the LUGANO and LUCIA trials. It seems like prior trials you had BCVA letters between 35 and 85 and now it's between 35 and 78. I'm just curious if you see what's the rationale behind using that cutoff at 78 instead of 75 letter -- 85 letters.

早安.愛德華多替補易建聯上場。感謝您回答這個問題。我對 LUGANO 和 LUCIA 試驗中的基線患者特徵有疑問。看起來之前的試驗中您的 BCVA 字母在 35 到 85 之間，而現在則在 35 到 78 之間。我只是好奇，您是否明白使用 78 個字母而不是 75 個字母 - 85 個字母作為截止值的理由是什麼。

Sure, Eduardo, good question. And the answer to that is in the pivotal trials, I think the FDA has made it clear both historically and in the draft guidelines that you must enroll patients who have active wet AMD into your trials.

當然，愛德華多，問得好。答案就在關鍵試驗中，我認為 FDA 已經從歷史上和指南草案中明確表示，必須招募患有活動性濕性 AMD 的患者參與試驗。

And what does that mean? Well, they meet they have to have imaging that shows that they have AMD and that they have an active choroidal neovascular membrane, and they have to have decreased vision, and they have to have some fluid on OCT that is indicative of wet AMD fluid. So in order to have decreased vision, there is a cutoff, and historically, I think if you go back to the other wet AMD trials, 78 letters is very typical for the best vision that is typically allowed into the study. So the quick answer to the question is, you have to enroll patients with active wet AMD.

那這意味著什麼？嗯，他們必須透過影像學檢查來證明自己患有 AMD，並且有活躍的脈絡膜新生血管膜，而且他們的視力必須下降，並且 OCT 上必須有一些液體表明存在濕性 AMD 液體。因此，為了達到視力下降的程度，就有一個截止值，從歷史上看，我認為，如果你回顧其他濕性 AMD 試驗，78 個字母是研究通常允許的最佳視力的典型值。因此，這個問題的快速答案是，您必須招募患有活動性濕性 AMD 的患者。

Got it. That's really helpful. And maybe you mentioned this, but you reported a subgroup within the DME trial, had the 10.3 letter improvement. I'm curious what are the attributes of that patient population and what fraction of the DME population show those attributes?

知道了。這真的很有幫助。也許您提到了這一點，但您報告了 DME 試驗中的一個子組，其成績提高了 10.3 個字母。我很好奇該患者群體的特徵是什麼，以及 DME 群體中有多少比例表現出這些特徵？

Well, so that's a really good question about what attributes show it. First of all, it was the subgroup of patients in the DME trial in the high-dose, the 2.7 milligram dose, which is the dose we're using in wet AMD and the presumed go-to-market dose, in that dose of the eyes that did not get rescued, they improved 10 letters.

嗯，這是一個很好的問題，關於什麼屬性可以顯示這一點。首先，這是 DME 試驗中高劑量 2.7 毫克劑量的患者亞組，這是我們在濕性 AMD 中使用的劑量和假定的上市劑量，在該劑量下，未得到挽救的眼睛的視力提高了 10 個字母。

So the implication being is when our drug works in DME, and it seemed to work in the vast majority of those patients out of the 11, it seemed to work quite well in the majority. It works really, really well. Those patients who were not rescued had an immediate improvement in vision seen at four weeks, they had immediate reduction in their OCT seen at four weeks and it was sustained in those eyes throughout the study.

因此，這意味著當我們的藥物對 DME 起作用時，它似乎對 11 名患者中的絕大多數都起作用，而且似乎對大多數患者都起到了相當好的作用。它確實非常有效。那些未接受搶救的患者在四周後視力立即得到改善，OCT 檢查結果也立即下降，並且在整個研究過程中，這些患者的視力得到維持。

In other words, at the tail end, near 24 weeks, the visual acuities weren't dropping and the eyes weren't getting more wet. And in fact, in that subgroup, they had about 120 microns improvement in their OCTs. So for that subgroup, it worked really well.

換句話說，在最後階段，接近 24 週時，視力不會下降，眼睛不會變得更濕潤。事實上，在該子組中，他們的 OCT 改善了約 120 微米。因此對於該子群體來說，它確實很有效。

Even though if you look at the patients who did get rescued, there was perhaps only one patient out of that group that you would say that really had active disease during the trial despite the use of our drug. So the other eyes that got rescued got rescued because they didn't have over 10% improvement in their OCTs, but they were still doing pretty well even at the time of rescue.

即使你看看那些確實獲救的病人，你也會發現其中可能只有一名病人儘管使用了我們的藥物，但在試驗期間仍然確實患有活動性疾病。因此，其他得到挽救的眼睛之所以得到挽救，是因為它們的 OCT 改善程度沒有超過 10%，但即使在挽救時，它們仍然表現得相當好。

So be that as it may, it would be great to be able to identify those patients, which I think is what your question was getting at, and because the end of the trial was relatively low, I don't think we have enough data right now to state which of the patients who can go six months with great improvement and will not need a rescue.

無論如何，如果能夠識別出這些患者就太好了，我認為這就是你的問題所要問的，而且由於試驗結束時患者人數相對較少，我認為我們現在沒有足夠的數據來說明哪些患者可以在六個月內有很大的改善並且不需要救援。

Hopefully -- we hope obviously in the pivotal trials, we'll be able to elucidate that, so that the retina community can identify the patients who are going to do best with the drug.

希望——我們顯然希望在關鍵試驗中，我們能夠闡明這一點，以便視網膜界能夠確定最適合該藥物的患者。

Got it. That's really helpful. Thanks so much.

知道了。這真的很有幫助。非常感謝。

Yigal Nochomovitz, Citigroup.

花旗集團的 Yigal Nochomovitz。

Yeah, hi, thank you. Can you just walk-through the thinking as far as your views on potentially being first to file an NDA for the long-acting TKIs, given the strength of the enrollment curves that you're seeing across your Phase III programs? Thank you.

是的，你好，謝謝你。鑑於您在 III 期專案中看到的註冊曲線強勁，您能否簡單介紹一下您對率先提交長效 TKI NDA 的看法？謝謝。

Thanks for the question, Yigal, I think the first two file, we've talked a little bit about this, what is it dependent on? It's dependent on last patient in your second pivotal trial. And we have great confidence given the enrollment rates that we're seeing in our trials and the timing of the various trials of the other long-acting agents that are out there, we are quite confident that we will get last patient in our second trial before any of the competitors do.

感謝 Yigal 提出的問題，我認為前兩個文件，我們已經討論過一點了，它依賴於什麼？這取決於第二次關鍵試驗的最後一名患者。並且，鑑於我們在試驗中看到的入組率以及其他長效藥物的各種試驗的時間安排，我們非常有信心，我們將在任何競爭對手之前在第二次試驗中獲得最後一位患者。

Given the length of the trial, 56 weeks, which is similar to what our competitors are doing, and the fact that our eyes get randomized on day one. There's no run-in before randomization. All of this gives us great confidence at this point that we will be first to file and if approved, therefore, we will have the first-to-market advantage.

考慮到試驗時間長達 56 週，這與我們的競爭對手的做法相似，而且我們的眼睛在第一天就被隨機化。隨機化前無需磨合。所有這些都讓我們非常有信心，我們將是第一個提交申請的人，如果獲得批准，我們將擁有先發優勢。

Okay, thank you, and could you just review your positioning with respect to supply chain and IP? You may have talked about it at the beginning, but I may have missed it.

好的，謝謝，您能否回顧一下您在供應鏈和 IP 方面的定位？您可能一開始就談到了這一點，但我可能錯過了。

So vis-a-vis supply chain for the commercial product, once again, as we did talk about in the opening remarks, our API is manufactured in the United States, and our inserts are manufactured by us here in Massachusetts. The Phase III wet AMD inserts were manufactured in our facility in Watertown.

因此，就商業產品的供應鏈而言，正如我們在開場白中提到的那樣，我們的 API 是在美國製造的，我們的插件是由我們在馬薩諸塞州製造的。第三階段濕式 AMD 插入件是在我們位於沃特敦的工廠生產的。

We have built a state-of-the-art manufacturing facility in Northbridge, Massachusetts, which is about an hour West of Watertown. And in that facility, we are in the midst of making registration batches and preparing for FDA premarket visits.

我們在馬薩諸塞州諾斯布里奇建造了一座最先進的製造工廠，距離沃特敦以西約一小時車程。在該工廠，我們正在進行註冊批次並為 FDA 上市前訪問做準備。

And we're confident that that facility will be able to supply the entire global need for DURAVYU, should we get approval. So from a supply chain perspective, we're really in control of the supply to a very large degree. And remember, also with the vorolanib is a small molecule, it's not a biologic, it's not gene therapy, and as such, the manufacturing is relatively less expensive, and because our inserts only contain each 1 milligram, 1.3 milligram of vorolanib, a batch or run of vorolanib can take us a very long way.

我們相信，一旦獲得批准，該工廠將能夠滿足全球對 DURAVYU 的所有需求。因此，從供應鏈的角度來看，我們實際上在很大程度上控制著供應。請記住，沃羅拉尼布是一種小分子，它不是生物製劑，也不是基因療法，因此，製造成本相對較低，而且由於我們的插入件僅含有 1 毫克、1.3 毫克沃羅拉尼布，一批或一輪沃羅拉尼布可以讓我們走很長的路。

So we are quite confident that our supply chain will be intact, and that the tariff issues that some companies are facing, we think we are in good shape there.

因此，我們非常有信心，我們的供應鏈將是完整的，而且對於一些公司面臨的關稅問題，我們認為我們的情況很好。

Alright. Thank you very much.

好吧。非常感謝。

Thank you. Ladies and gentlemen, I'm showing no further questions in the queue at this time. This does conclude your program. Thank you for participating in today's conference. You may now disconnect. Everyone, have a great day.

謝謝。女士們、先生們，目前隊列中沒有其他問題。這確實結束了你的計劃。感謝大家參加今天的會議。您現在可以斷開連線。祝大家有個愉快的一天。