EyePoint Inc (EYPT) 2026 Q1 法說會逐字稿

Good morning. My name is Brittany, and I'll be your conference operator today. At this time, I would like to welcome everyone to the EyePoint first-quarter 2026 financial results and recent corporate development conference call. (Operator Instructions) Please be advised that this call is being recorded at the company's request.

早安。我叫 Brittany，今天將擔任本次會議的接線員。此刻，我想歡迎各位參加 EyePoint 2026 會計年度第一季財務業績與近期公司發展電話會議。(接線員指示) 請注意，應公司要求，本通話將被錄音。

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

接下來我想把電話交給 EyePoint 執行副總裁兼財務長 George Elston。

Thank you, and thank you all for joining us on today's conference call to discuss EyePoint's first-quarter 2026 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 our ongoing clinical programs for DURAVYU in wet AMD and DME.

謝謝，也感謝各位參加今天的電話會議，一同討論 EyePoint 2026 會計年度第一季財務業績與近期公司發展。今天與我一同出席的還有 EyePoint 總裁兼執行長 Jay Duker 醫師。Jay 將先回顧近期公司最新進展，並說明我們針對濕性 AMD 與 DME 的 DURAVYU 持續進行中的臨床計畫。

I will close with commentary on the first-quarter 2026 financial results. We will then open the call for your questions, where we will be joined by Dr. Ramiro Ribeiro, our Chief Medical Officer; and Mike Campbell, our Chief Commercial Officer. Earlier this morning, we issued a press release detailing our financial results and recent corporate developments.

我將在最後就 2026 會計年度第一季財務業績進行說明。接著我們將開放提問，屆時也會有我們的醫務長 Ramiro Ribeiro 醫師，以及商務長 Mike Campbell 一同加入。今天稍早，我們已發布新聞稿，詳述我們的財務業績與近期公司發展。

A copy of the release can be found in the Investor Relations tab on the company website, www.yepoint.bio. 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.

新聞稿可在公司網站 www.yepoint.bio 的投資人關係（Investor Relations）頁籤中找到。在我們開始正式發言之前，我要提醒各位，我們今天所做的各項陳述中，部分屬於《1995 年私人證券訴訟改革法》（Private Securities Litigation Reform Act of 1995）安全港條款所界定的前瞻性陳述。

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. 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.

其中包括關於我們對未來的預期、臨床進展與法規事項及時間表、我們產品與產品候選藥物的潛在成功、財務預測，以及我們的計畫與前景等陳述。由於多項重要因素，實際結果可能與這些前瞻性陳述所示存在重大差異，包括我們最近一期 Form 10-K 年度報告的風險因素章節中所討論者；該報告已向美國證券交易委員會（SEC）提交存檔，且我們亦已或未來可能向 SEC 提交其他文件。

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日的觀點。雖然我們未來可能選擇在某個時間點更新這些前瞻性陳述，但即使我們的觀點有所改變，我們亦明確聲明不負有更新義務。因此，您不應依賴這些前瞻性陳述作為今日之後任何日期我們觀點的代表。

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

現在我把電話交給 EyePoint 總裁兼執行長 Jay Duker 醫師。

Thank you, George. Good morning, everyone, and thank you for joining us. The start of 2026 for EyePoint was marked by a strong quarter of consistent execution as we approach a pivotal inflection point for our lead program, DURAVYU. We have strong conviction that the upcoming LUGANO and LUCIA readouts will catalyze our future transition into a fully integrated biopharmaceutical company, furthering our mission of improving the lives of patients with serious retinal disease.

謝謝你，George。各位早安，感謝各位加入我們。對 EyePoint 而言，2026 年的開端以強勁的一季揭開序幕；在我們邁向主力計畫 DURAVYU 的關鍵轉折點之際，我們持續穩健執行。我們深信，即將公布的 LUGANO 與 LUCIA 讀出結果將成為催化劑，推動我們未來轉型為一家完整整合的生物製藥公司，並進一步實現我們改善嚴重視網膜疾病患者生活的使命。

We remain on track to deliver these Phase III top line data in wet age-related macular degeneration or wet AMD, beginning mid-year, positioning us to potentially be the first to market among all current investigational sustained release programs. In Diabetic Macular Edema, or DME, we are seeing strong momentum in our Phase III program with enrollment rapidly progressing to support our ambitious goal of full enrollment in both pivotal trials in the third-quarter of 2026.

我們仍按計畫於年中開始公布濕性年齡相關性黃斑部病變（wet age-related macular degeneration，或 wet AMD）的第三期主要（top line）數據，使我們有機會在所有目前研發中的長效釋放計畫中率先上市。在糖尿病黃斑水腫（Diabetic Macular Edema，或 DME）方面，我們的第三期計畫動能強勁，收案快速推進，以支持我們在 2026 年第三季於兩項關鍵性試驗完成全數收案的宏大目標。

As we advance towards these significant milestones, we are confident that our clinically-rigorous, derisked and patient-centric approach will continue to reinforce DURAVYU's best-in-class potential in the two largest retinal disease markets. The fundamental strength of the DURAVYU program lies in its robust and differentiated clinical data.

隨著我們朝這些重要里程碑邁進，我們有信心，我們臨床嚴謹、去風險化且以病患為中心的方法，將持續強化 DURAVYU 在兩個最大視網膜疾病市場中的同級最佳（best-in-class）潛力。DURAVYU 計畫的根本優勢在於其強健且具差異化的臨床數據。

In Phase II trials, a single dose of DURAVYU demonstrated durable efficacy with improved vision and tight anatomic control. In over 190 patients across four completed clinical trials, DURAVYU has demonstrated a consistently favorable safety profile with no safety signals. That profile continues to hold in our ongoing Phase III LUGANO and LUCIA trials for wet AMD as observed on a mass basis, where our low discontinuation rate of about 5% remains well below the 10% yearly average typical for wet AMD trials.

在第二期試驗中，DURAVYU 單次給藥即展現持久療效，並改善視力與維持良好的解剖學控制。在四項已完成的臨床試驗、超過 190 名患者中，DURAVYU 一貫展現良好的安全性概況，且未出現任何安全性訊號。在我們針對濕性 AMD 進行中的第三期 LUGANO 與 LUCIA 試驗中，依整體觀察（on a mass basis），該安全性概況仍持續成立；我們約 5% 的低中止率，仍明顯低於濕性 AMD 試驗常見的每年約 10% 平均值。

Importantly, none of these discontinuations were related to treatment. At this stage, all patients across the LUGANO and LUCIA trials have reached the week-32 visit, during which patients in the DURAVYU arms received their second DURAVU dose. Over 35% of those patients have since received their third planned dose of DURAVU at week 56.

重要的是，這些中止個案皆與治療無關。截至目前，LUGANO 與 LUCIA 兩項試驗的所有患者都已完成第 32 週回診；在該次回診中，DURAVYU 組患者接受了第二次 DURAVU 劑量。其中超過 35% 的患者此後已在第 56 週接受第三次預定的 DURAVU 劑量。

As a reminder, we received two consecutive positive recommendations from the independent Data Safety Monitoring Committee with a third review scheduled for later this month. We are optimistic that the interim masked safety data will continue to remain consistent, further strengthening DURAVYU's clinical profile. In addition, we believe the multi-mechanism of action or MOA of DURAVYU's active ingredient, vorolanib, will prove to be a key clinical differentiator.

提醒各位，我們已連續兩次獲得獨立資料安全監測委員會（Data Safety Monitoring Committee）的正面建議，第三次審查預計於本月稍晚進行。我們樂觀預期，期中盲態（masked）安全性數據將持續保持一致，進一步強化 DURAVYU 的臨床概況。此外，我們相信 DURAVYU 活性成分 vorolanib 的多重作用機轉（multi-mechanism of action，或 MOA）將被證明是關鍵的臨床差異化因素。

Along with blocking all VEGF isoforms and PDGF at the receptor level, preclinical data supports vorolanib's ability to inhibit IL-6 signaling via the JAK1 receptor. With this unique ability to not only address both the vascular leakage and inflammation that contributes to retinal disease pathogenesis, but also potentially provide sustained release efficacy, DURAVYU is uniquely designed to deliver wide-reaching therapeutic potential.

除了在受體層級阻斷所有 VEGF 異構型（isoforms）與 PDGF 之外，臨床前數據亦支持 vorolanib 可透過 JAK1 受體抑制 IL-6 訊號傳導。憑藉這項獨特能力，DURAVYU 不僅能同時處理導致視網膜疾病致病機轉的血管滲漏與發炎，亦可能提供長效釋放的療效，因此其設計可望帶來廣泛的治療潛力。

Earlier this week, we presented peer-reviewed data at the Association for Research in Vision and Ophthalmology, or ARVO meeting that reinforces these findings and further substantiate DURAVYU's potential to improve long-term outcomes for patients. A primary kinase screen and subsequent measure of IC50 levels identified vorolanib as a potent inhibitor of JAK1, which plays a critical role in IL-6 mediated inflammation.

本週稍早，我們在視覺與眼科研究協會（Association for Research in Vision and Ophthalmology，或 ARVO）年會上發表了同儕審查（peer-reviewed）數據，強化上述發現，並進一步佐證 DURAVYU 改善患者長期結局的潛力。主要激酶篩選（primary kinase screen）及後續 IC50 水準測定顯示，vorolanib 是 JAK1 的強效抑制劑；JAK1 在 IL-6 介導的發炎反應中扮演關鍵角色。

In addition, vorolanib proved to be a potent inhibitor of IL-6 leakage in an in vitro cellular model. This data further highlights the multi-MOA potential of DURAVYU with the opportunity to bring a synergistic anti-inflammatory effect in addition to established VEGF and PDGF inhibition to the treatment of wet AMD and DME.

此外，在體外（in vitro）細胞模型中，vorolanib 亦被證實能強力抑制 IL-6 滲漏。這些數據進一步凸顯 DURAVYU 的多重 MOA 潛力：除既有的 VEGF 與 PDGF 抑制外，亦有機會為濕性 AMD 與 DME 的治療帶來協同的抗發炎效果。

As we near top line data for our Phase III wet AMD program, it's worth remembering the key elements underpinning its thoughtful design. Our approach is derisked, following an established non-inferiority regulatory pathway. Both pivotal trials are identical and compared DURAVYU to on-label 2-milligram aflibercept, which is intended to reflect real-world practice and generate clinically-relevant data to inform the retina community.

隨著我們接近濕性 AMD 第三期計畫的主要數據公布，值得回顧支撐其周延設計的關鍵要素。我們的策略已去風險化，遵循既定的非劣性（non-inferiority）法規路徑。兩項關鍵性試驗設計完全相同，並將 DURAVYU 與標示適應症（on-label）的 2 毫克 aflibercept 進行比較；此設計旨在反映真實世界臨床實務，並產生具臨床相關性的數據，以提供視網膜領域社群參考。

Additionally, both trials are evaluating 6-month redosing and statistical superiority in treatment burden reduction to support the potential for a compelling label that addresses the need for effective, durable disease control. Taken together, we believe our Phase III program is well positioned to deliver data that will build upon our positive clinical development track record and contribute to strong commercial positioning for DURAVYU, if approved.

此外，兩項試驗亦在評估每 6 個月再給藥（redosing），以及在降低治療負擔方面的統計學優越性（statistical superiority），以支持未來可能取得具吸引力的標籤（label），回應對有效且持久疾病控制的需求。綜合而言，我們相信我們的第三期計畫已具備良好條件，可望交出能延續我們正向臨床開發紀錄的數據，並在 DURAVYU 若獲核准時，促成強勁的商業定位。

We look forward to reporting top line data from our Phase III wet AMD trial, LUGANO, this summer with our second trial, LUCIA to follow shortly thereafter. We are applying the same derisked approach to our Phase III DME program, which leverages a non-inferiority design, an on-label 2-milligram aflibercept control, and redosing every six-months.

我們期待於今年夏天公布第三期濕性 AMD 試驗 LUGANO 的主要（top line）數據，第二項試驗 LUCIA 也將在其後不久公布。我們將同樣經過去風險化（derisked）的策略應用於第三期 DME 計畫，該計畫採用非劣性設計、使用標籤適應症內（on-label）的 2 毫克 aflibercept 作為對照，並每六個月重新給藥一次。

Similar to our wet AMD program, we designed our pivotal trials for DME based on impressive data from the Phase II VERONA study in which DURAVYU demonstrated rapid efficacy with four to five letters of vision improvement and approximately 50-micron improvement in anatomic control compared to aflibercept at week four.

與我們的濕性 AMD 計畫類似，我們根據第二期 VERONA 研究的亮眼數據設計了 DME 的關鍵性試驗；在該研究中，DURAVYU 於第 4 週相較於 aflibercept 展現快速療效，視力提升 4 到 5 個字母，且在解剖學控制方面改善約 50 微米。

Both of our DME trials, COMO and CAPRI are now underway with over 1/3 of patients enrolled across both trials following first patient dosing at the end of February of this year. Our strong pace of enrollment is driven by our ability to leverage our pre-existing clinical trial infrastructure and investigator network as well as the significantly smaller trial size compared to our wet AMD program.

我們兩項 DME 試驗 COMO 與 CAPRI 目前均已啟動；自今年 2 月底完成首位受試者給藥後，兩項試驗合計已完成超過三分之一的受試者入組。我們強勁的入組速度，來自於能夠運用既有的臨床試驗基礎設施與研究者網絡，以及相較於濕性 AMD 計畫顯著更小的試驗規模。

We expect top line data in the second half of 2027. Stepping back, both wet AMD and DME together represent the vast majority of the global branded retinal disease treatment market with a combined branded opportunity totaling nearly $15 billion in the US and growing. Through exceptional clinical leadership and commitment to serving the retinal community, we are positioning DURAVYU to become a durable franchise with blockbuster potential.

我們預期將於 2027 年下半年取得主要（top line）數據。從更宏觀的角度來看，濕性 AMD 與 DME 合計代表全球品牌視網膜疾病治療市場的絕大部分，在美國的品牌化機會合計接近 150 億美元，且仍在成長。透過卓越的臨床領導力與服務視網膜社群的承諾，我們正將 DURAVYU 定位為具持久性的產品系列（franchise），並具備重磅藥（blockbuster）潛力。

With a unique multi-MOA, robust clinical data package, proven delivery technology, the ability to be shipped and stored at ambient temperatures and administration via standard in-office intravitreal injection, DURAVYU represents a compelling and truly innovative product profile that has the potential to reshape the treatment paradigm for serious retinal diseases.

憑藉獨特的多重作用機制（multi-MOA）、扎實的臨床數據組合、經驗證的給藥技術、可於常溫運輸與儲存的能力，以及可透過標準院內玻璃體內注射（intravitreal injection）進行給藥，DURAVYU 呈現出具吸引力且真正創新的產品特性，有潛力重塑嚴重視網膜疾病的治療典範。

We continue to make significant strides in our commercial readiness while remaining disciplined in our investments as we prepare for regulatory submission. We have thoughtfully grown our organization with the addition of Michael Campbell as Chief Commercial Officer last quarter. In addition to expansion across key areas such as marketing and market access, regulatory, compliance and medical affairs to build on our organizational capabilities as we advance our launch planning and strategy for DURAVYU in wet AMD.

在為法規申報做準備之際，我們持續在商業化就緒方面取得重大進展，同時在投資上保持紀律。我們在上季審慎擴充組織，新增 Michael Campbell 擔任首席商務長（Chief Commercial Officer）。此外，我們也在行銷與市場准入、法規、合規與醫藥事務等關鍵領域擴編，以強化組織能力，並推進 DURAVYU 於濕性 AMD 的上市規劃與策略。

In addition to progress on our commercial readiness activities, we continue to prioritize CMC readiness. Our cGMP facility in Northbridge, Massachusetts has been online for over a year, supporting our plans for an anticipated CMC submission for our potential new drug application or NDA as well as for commercial supply, if approved.

除商業化就緒活動的進展外，我們也持續將 CMC 就緒列為優先事項。我們位於麻薩諸塞州 Northbridge 的 cGMP 廠房已上線運作超過一年，支援我們預期的 CMC 申報（用於潛在的新藥申請 NDA），並在獲批後支援商業供應。

We continue to prepare for pre-approval inspection, underscoring our growing independent commercial readiness that we believe will ensure our preparedness to deliver DURAVYU to patients upon potential approval. Before passing it over to George to review the financials, I'd like to thank the entire EyePoint team for your unwavering commitment to improving the quality of retinal care.

我們持續為核准前查廠（pre-approval inspection）做準備，凸顯我們日益成熟的獨立商業化就緒能力；我們相信這將確保在潛在獲批後，能夠將 DURAVYU 交付給患者。在把時間交給 George 回顧財務之前，我想感謝整個 EyePoint 團隊對提升視網膜照護品質的堅定承諾。

We are proud to support the retina community and grateful to the patients, study coordinators and clinical investigators who enable our research. We look forward to our upcoming Phase III wet AMD readouts together with continued progress in our DME program, which we believe sets the stage for meaningful value creation at EyePoint.

我們很榮幸能支持視網膜社群，並感謝讓我們研究得以進行的患者、研究協調員與臨床研究者。我們期待即將公布的第三期濕性 AMD 讀出（readouts），並持續推進 DME 計畫；我們相信這將為 EyePoint 創造具意義的價值奠定基礎。

I will now turn the call over to George.

我現在把電話交給 George。

Thank you, Jay. As the financial results for the three months ended March 31, 2026, were included in the press release issued this morning, my comments today will be focused on a high-level review for the quarter. Importantly, we continued our disciplined financial management and good stewardship of our resources, ending the first-quarter with $223 million in cash and investments.

謝謝你，Jay。由於截至 2026 年 3 月 31 日止三個月的財務結果已包含在今天早上發布的新聞稿中，我今天的評論將聚焦於本季的高層次回顧。重要的是，我們持續維持嚴謹的財務管理與良好的資源運用，第一季末現金與投資為 2.23 億美元。

For the quarter ended March 31, 2026, total net revenue was $0.7 million compared to $24.5 million for the quarter ended March 31, 2025. The decrease was primarily driven by the recognition of remaining deferred revenue related to the company's agreement in the second-quarter of 2023 for the license of YUTIQ product rights.

截至 2026 年 3 月 31 日止季度，總淨營收為 70 萬美元，較截至 2025 年 3 月 31 日止季度的 2,450 萬美元下降。下降主要是因公司於 2023 年第二季就授權 YUTIQ 產品權利所簽訂協議之相關剩餘遞延收入已予以認列。

Operating expenses for the quarter ended March 31, 2026, totaled $88 million compared to $73 million in the prior year period. This increase was primarily driven by the ongoing Phase III trials for DURAVYU in both wet AMD and DME and the scaleup of our Northbridge commercial manufacturing facility. Net non-operating income totaled $2 million and net loss was $85 million or $0.99 per share compared to a net loss of $45 million or $0.65 per share for the prior year period.

截至 2026 年 3 月 31 日止季度，營業費用合計 8,800 萬美元，較去年同期的 7,300 萬美元增加。增加主要來自 DURAVYU 在濕性 AMD 與 DME 的第三期試驗持續進行，以及我們 Northbridge 商業製造廠的擴產。非營業淨收益合計 200 萬美元，淨損為 8,500 萬美元或每股 0.99 美元；相較去年同期淨損 4,500 萬美元或每股 0.65 美元。

As I noted earlier, cash, cash equivalents and investments in marketable securities on March 31, 2026, totaled $223 million compared to $306 million as of December 31, 2025. We continue to expect that our current cash position will enable us to fund operations into the fourth-quarter of 2027 beyond key milestones for the Phase III wet AMD program expected later this year.

如我先前所提，於 2026 年 3 月 31 日，現金、約當現金及有價證券投資合計 2.23 億美元，較 2025 年 12 月 31 日的 3.06 億美元下降。我們仍預期目前的現金水位可支應營運至 2027 年第四季，並可跨越預計於今年稍晚取得的濕性 AMD 第三期計畫關鍵里程碑。

In conclusion, we're pleased with EyePoint's progress so far in 2026 and remain well capitalized to deliver DURAVYU through key value-driving milestones in the two largest retinal disease markets.

總結而言，我們對 EyePoint 在 2026 年迄今的進展感到滿意，且資本充足，能在兩個最大的視網膜疾病市場中，推進 DURAVYU 並達成多項關鍵的價值驅動里程碑。

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

我現在把電話交回給 Jay 進行結語。

Thank you, George. As we continue to deliver on our key priorities for 2026, our team is focused on advancing preparations for the pivotal Phase III top line data readout in wet AMD expected mid-year and completing enrollment of our Phase III DME program in the third-quarter of this year. We believe TKIs represent the next frontier in retinal disease innovation, and we are proud to be advancing DURAVYU as a potential first and best-in-class option in the two largest retinal disease markets.

謝謝你，George。在我們持續落實 2026 年的關鍵優先事項之際，團隊正專注於推進濕性 AMD 第三期關鍵試驗主要（top line）數據讀出（預計年中）之準備工作，並於今年第三季完成第三期 DME 計畫的入組。我們相信 TKI 代表視網膜疾病創新的下一個前沿，我們也很自豪能推進 DURAVYU，作為在兩個最大視網膜疾病市場中潛在的首創且同類最佳（first and best-in-class）選擇。

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

感謝各位今天早上的聆聽。我現在把電話交回給接線員進行提問。

(Operator Instructions) Tess Romero, JPMorgan.

（接線員指示）Tess Romero，摩根大通（JPMorgan）。

So just one from us, on the DME side, actually. So for your COMO and CAPRI trials, you talked a bit about your swift pace of enrollment here. Can you speak to what you're hearing from the investigators in terms of the level of interest from both patients and physicians around a TKI sustained delivery treatment option like DURAVYU? What are the key differences and similarities that you hear in the DME space versus maybe what you heard in the wet AMD space?

我們這邊只有一個問題，關於 DME。針對你們的 COMO 與 CAPRI 試驗，你們提到目前入組速度很快。能否談談你們從研究者那邊聽到的回饋：就像 DURAVYU 這類 TKI 長效給藥（sustained delivery）治療選項，患者與醫師的興趣程度如何？你們在 DME 領域聽到的關鍵差異與相似之處，與濕性 AMD 領域相比是什麼？

Thanks for the question, Tess. Given that our CMO, Ramiro Ribeiro, is really at the forefront of this, I'll ask him to answer your question.

謝謝你的問題，Tess。鑑於我們的首席醫務長（CMO）Ramiro Ribeiro 確實站在這方面的最前線，我會請他來回答你的問題。

Tess, thanks for the question. So first, as you mentioned, we are seeing a great excitement around our DME program, COMO and CAPRI with a quite quick enrollment so far. We are now leveraging all the infrastructure that we use for our wet AMD with our clinical sites and our CRO and vendor as well. The feedback that we're getting from the investigators, very similar to our wet AMD, is that our study is a very patient-centric study, trying to address a very important unmet need, which is the treatment burden.

Tess，謝謝你的問題。首先，如你所提到的，我們看到市場對 DME 計畫 COMO 與 CAPRI 的高度興奮，目前入組速度相當快。我們現在正運用先前在濕性 AMD 所使用的所有基礎設施，包括臨床試驗中心，以及我們的 CRO 與供應商。我們從研究者收到的回饋，與濕性 AMD 非常相似：我們的研究非常以患者為中心，試圖解決一個非常重要、尚未被滿足的需求，也就是治療負擔。

So patients that are participating in this study are very excited for a therapy that can last for about six months. In particular, for the DME indication, we know that the need for this patient population might be even greater than wet AMD. This is a patient population that is relatively younger, and they are still in the workplace.

因此，參與這項研究的患者對於一種可維持約六個月的治療非常興奮。特別是在 DME 適應症方面，我們知道這一患者族群的需求可能甚至高於濕性 AMD。這是一個相對較年輕的患者族群，而且他們仍在職場工作。

So a therapy that can reduce the number of visits like DURAVYU is, of course, of very interest for this patient population. Again, I think the excitement both from the investigators, the patient in clinical sites is being reflected in the pace of our enrollment.

因此，像 DURAVYU 這樣能減少就診次數的治療，當然對這一患者族群非常有吸引力。同樣地，我認為研究者與臨床試驗中心患者的熱情，也反映在我們入組速度上。

And I'd like to add just one more thought to this. We invited 90 of our wet AMD investigators to be investigators in the DME trials and all 90 accepted. So we believe that continues to show investigators' enthusiasm for the potential of DURAVYU.

我還想再補充一點。我們邀請了 90 位濕性 AMD 的研究者擔任 DME 試驗的研究者，90 位全數接受。因此，我們相信這持續顯示研究者對 DURAVYU 潛力的熱忱。

Yigal Nochomovitz, Citigroup.

Yigal Nochomovitz，花旗集團。

I'm just wondering if you could comment on how the supplement trigger criteria are functioning in the Phase III trial relative to the Phase II trial, the DAVIO 2 trial? And if you could also comment on what you would expect to be a meaningful supplement rate in the Phase III trial that would be consistent with a strong commercial uptake.

我想請教一下，第三期試驗中的補救治療（supplement）觸發標準，相較於第二期試驗 DAVIO 2，是如何運作的？另外，您能否談談在第三期試驗中，什麼樣的補救治療比例會被視為具有強勁商業採用、且具意義的水準？

Yigal, nice to hear from you. Thanks for the question. With respect to supplements, I'm going to have Ramiro comment in a moment about how that is working in the trial. But I think there's really two issues around the supplementation that people should understand. The first is that in the clinical trials, supplements will be handled statistically with sensitivity analyses that we will be doing when we submit the NDA.

Yigal，很高興聽到你的聲音。謝謝你的問題。關於補救治療，我稍後會請 Ramiro 說明其在試驗中的運作方式。但我認為大家需要理解，補救治療其實有兩個面向。第一，在臨床試驗中，補救治療將在我們提交 NDA 時，透過我們將進行的敏感度分析，以統計方式處理。

So there is a rate of supplements, at least conceivably, above which the drug would not be considered to be working independently because of the high rate of supplements. In saying that, the FDA has never put a line in the sand as to what that level would be, because they want to see the totality of the data. They want to see the safety and the efficacy otherwise.

因此，至少在概念上，補救治療的比例可能存在某個上限；一旦高於該水準，因補救治療比例過高，藥物就不會被認為能獨立發揮作用。但即便如此，FDA 從未明確劃定一條界線說那個水準是多少，因為他們希望看到整體資料。他們也希望看到安全性與其他方面的有效性。

So, from a supplementation perspective, there is an important hurdle, which, of course, we need to get over, which is the non-inferior margin, which is the primary endpoint. If we are approved, then I think the commercial acceptance shifts to a very different place. In the real world, a supplement is not a failure. Doctors, I believe, if we are approved, will enjoy taking advantage of using 2 MOAs to help a (technical difficulty) across a lot of chronic diseases, where if 2 MOAs in treatment are available, using them synergistically is a potential advantage to patients.

因此，從補救治療的角度來看，有一個重要門檻——當然我們必須跨過——也就是主要終點的非劣性界值。如果我們獲得核准，我認為商業端的接受度就會轉向一個非常不同的層面。在真實世界中，補救治療並不代表失敗。我相信如果我們獲准，醫師會樂於運用兩種作用機轉（2 MOAs）來協助（技術問題）在許多慢性疾病中；當治療上有兩種作用機轉可用時，協同使用可能對患者是一項潛在優勢。

Now obviously, we haven't shown that yet in our trials, but we hope that, that would be the case for the benefit of patients. But my point about supplements in the real world, I'll give you again an example. If I've got a patient that I have to inject every two months with a biologic anti-VEGF and let's hypothesize that DURAVYU is FDA approved, it's safe, it's tolerable. It has a label for every 6 months and the patient gets shifted to DURAVYU, for the next year with two injections.

當然，我們在試驗中尚未證明這一點，但我們希望為了患者利益，情況會是如此。不過我想再談談真實世界中的補救治療，我再舉個例子。如果我有一位患者必須每兩個月注射一次生物製劑抗 VEGF，並假設 DURAVYU 已獲 FDA 核准，且安全、耐受性良好。它的標示為每六個月一次，患者改用 DURAVYU 後，接下來一年只需兩次注射。

But in addition, they received two injections of a biologic. Well, it's a great win for everyone. The patient can go from every two months to every three months from six injections to four injections and that presumably the advantages of DURAVYU will be aligned with the patient and the doctor's interest. So there is the regulatory hurdle that needs to be reached over supplements. And if that's reached, I believe that supplementation in the real world will have great latitude for acceptance.

但此外，他們又接受了兩次生物製劑注射。那麼，這對所有人都是很大的勝利。患者可以從每兩個月一次變成每三個月一次，從六次注射降到四次注射，而 DURAVYU 的優勢也可望與患者與醫師的利益一致。因此，補救治療在法規上有一個必須跨越的門檻。一旦跨過，我相信在真實世界中，補救治療將有很大的接受彈性。

Okay. And then if I could just ask one other follow-up on DME. Of course, you mentioned IL-6 as a potentially interesting biomarker. Are any of those IL-6 biomarker endpoints formally embedded in the Phase III DME program as sort of secondary endpoints that could help differentiate the product?

好的。那我再追問一個關於 DME 的問題。當然，你提到 IL-6 可能是一個有趣的生物標記。在第三期 DME 計畫中，是否有任何 IL-6 生物標記的終點被正式納入，例如作為可協助產品差異化的次要終點？

I would say yes, but indirectly. Given that there is no way to measure in a patient in a clinical trial, the direct effects on IL-6 or JAK1, we would be measuring the indirect effects. The indirect effects, of course, number one is visual acuity. What we hope to be doing in the long term is provide better visual acuity for patients. But in DME, we may be able to provide it in the short term.

我會說是，但屬於間接方式。由於在臨床試驗中沒有方法在患者身上量測 IL-6 或 JAK1 的直接影響，我們會量測其間接影響。間接影響當然第一個是視力（視覺敏銳度）。我們長期希望能為患者提供更好的視力。但在 DME 中，我們可能在短期內就能提供改善。

Again, looking at the VERONA data at week four, the patients who received DURAVYU had better vision and drier retinas as early as week four compared to a single dose of aflibercept. We have set up the COMO and CAPRI trials to try to show that. And there is a secondary endpoint of visual acuity and OCT at week four, given our drug is given at day 1 in the DME trials so that -- we hope to show that even if we're non-inferior and equivalent to Eylea, but we can provide the benefit earlier with fewer injections, then we will be able to have a great advantage to patients and therefore, a commercial success.

同樣地，回看 VERONA 在第 4 週的數據，接受 DURAVYU 的患者早在第 4 週就呈現較佳視力與較乾的視網膜，相較於單次劑量的 aflibercept。我們設計了 COMO 與 CAPRI 試驗來嘗試證明這一點。並且設有第 4 週的視力與 OCT 次要終點；鑑於我們的藥物在 DME 試驗中於第 1 天給藥，因此——我們希望證明即使我們僅達到非劣性、與 Eylea 等效，但若能以更少注射更早帶來效益，我們就能為患者帶來很大優勢，進而取得商業成功。

There are other secondary endpoints that we can look at that are not direct measurements of IL-6 or JAK inhibition. For example, leakage on fluorescein angiography. And you may recall that in the VERONA trial, we had a significant reduction in leakage as measured by an independent reading center, and it was dose-dependent, with the higher dose of 2.7 milligrams showing much greater leakage reduction compared to the lower dose and compared to the aflibercept control.

我們也可以觀察其他次要終點，但它們並非 IL-6 或 JAK 抑制的直接量測。例如，螢光素血管攝影上的滲漏。你可能記得在 VERONA 試驗中，我們由獨立判讀中心量測到滲漏顯著降低，而且呈劑量依賴性；2.7 毫克的高劑量相較於低劑量以及相較於 aflibercept 對照組，顯示更大幅度的滲漏降低。

And that is the kind of secondary endpoint that if we can show reduction in leakage greater than aflibercept, I think the evidence would lead to that is due to IL-6 inhibition.

而這類次要終點，如果我們能證明滲漏降低幅度優於 aflibercept，我認為證據將指向其原因是 IL-6 抑制。

Faisal Khurshid, Jefferies.

Faisal Khurshid，Jefferies。

I just wanted to ask on the ongoing wet AMD studies, are you guys able to see blinded rescue rates? And are those tracking in line with your expectations?

我想問一下關於正在進行的濕性 AMD 研究，你們是否能看到盲態下的補救（rescue）比例？而且這些數據是否符合你們的預期走勢？

Thanks for the question, Faisal. Again, I'll let Ramiro talk about the supplementations and what we're seeing and what we're not seeing.

謝謝你的問題，Faisal。同樣地，我會讓 Ramiro 談談補救治療，以及我們看得到與看不到的部分。

Faisal, thanks for the question. We -- there's a very small team at EyePoint that reviews the supplementation injections essentially to make sure that the clinical sites are following the protocol. But we don't review aggregated supplemental injection rate, and that's something that we don't disclose publicly.

Faisal，謝謝你的問題。我們——EyePoint 有一個非常小的團隊會審查補救注射，基本上是為了確保各臨床試驗中心遵循試驗方案。但我們不會審查彙總後的補救注射比例，而這也是我們不會對外公開揭露的事項。

And if I may add, we -- again, as Ramiro indicated, have no insight into the number of supplements, supplementation rate, et cetera, at this point. It's all masked. But we do anticipate that the supplementation rates in the Phase III trials will be less than what we saw in the Phase II for several reasons, again, due to the tightening of the supplement criteria, getting rid of the physician discretion in supplements, the reinjection at month six and the inclusion of the majority of naive patients, all of those together should result in fewer supplements in Phase III.

另外我補充一下，我們——如 Ramiro 所指出——目前對補救次數、補救比例等沒有任何洞見。一切都在盲態中。但我們確實預期第三期試驗的補救比例會低於第二期，原因有幾點：包括收緊補救標準、取消醫師在補救上的裁量權、第 6 個月再注射，以及納入多數未治療（naive）患者；這些因素加總起來，應會使第三期的補救更少。

Yatin Suneja, Guggenheim.

Yatin Suneja，Guggenheim。

I'm sorry. This is Eddie on for Yatin. Thinking about the fixed-dose regimen that you guys are going after, are patients who are already dry with stable vision still receiving that third dose at week 56? And if so, is there any incremental safety signal from redosing well-controlled patients? And further, has the FDA weighed in on how this complicates the retreatment redosing schedule?

抱歉。我是 Eddie，代替 Yatin。關於你們正在推進的固定劑量給藥方案，對於那些已經乾燥且視力穩定的患者，在第 56 週仍然會接受第三次給藥嗎？如果是的話，對於重新給藥於控制良好的患者，是否有任何額外的安全性訊號？另外，FDA 是否就這會如何使再治療的重新給藥時程更複雜而提供意見？

Thanks, Eddie. Very good question. And yes, this is a fixed dose regimen. It has nothing to do with whether the patient at the time of their repeat dose of DURAVYU is dry or wet or what the visual acuities are. So just like any drug, for example, take 2-milligram Eylea, when it was first studied every two months, that was fixed dose where they received that injection, whether they were active or not.

謝謝你，Eddie。非常好的問題。是的，這是一個固定劑量給藥方案。它與患者在 DURAVYU 重複給藥時是乾或濕、或視力如何，完全無關。所以就像任何藥物一樣，例如 2 毫克 Eylea，當初研究每兩個月給藥時，那就是固定劑量，不論是否仍有活動性，都會接受注射。

So that's going to be true in our trial. From the perspective of safety, we've done extensive preclinical safety in animals. And in rabbits, we never found a maximally tolerated dose of vorolanib, and we've injected scale dose of about 10 times higher than anything we could achieve in humans. We've also not found the maximally tolerated number of inserts in rabbits.

因此在我們的試驗中也會如此。從安全性的角度來看，我們已在動物中做了大量的臨床前安全性研究。在兔子中，我們從未找到 vorolanib 的最大耐受劑量，而且我們注射的按比例換算劑量約為人類可達到的任何劑量的 10 倍。我們也未在兔子中找到可耐受的最大植入次數。

And so from a safety perspective, we were not concerned about reinjection. Again, we are reviewing the masked safety. And I will once again turn to Ramiro if he wants to comment on the upcoming DMC meeting that is going to be occurring shortly.

因此從安全性的角度，我們不擔心再次注射。再次強調，我們正在審閱盲態的安全性資料。我也再次請 Ramiro，如果他願意的話，談談即將在近期召開的 DMC 會議。

Yes. No, thanks, and thanks, Eddie, for the question. We -- as Jay mentioned, safety is something that is, of course, paramount for EyePoint, and we conduct ongoing safety review of the data. If you do the math, we have now have patients that reached that week 56 visit that you mentioned, which is the third dose of EYP-1901, and we haven't seen anything different than what we saw before.

是的。不，謝謝，也謝謝你，Eddie，提出這個問題。我們——如 Jay 所提到的，安全性當然是 EyePoint 最重視的，我們也持續進行資料的安全性審查。如果你做一下計算，我們現在已有患者到達你提到的第 56 週回診，也就是 EYP-1901 的第三次給藥，而我們沒有看到任何與先前不同的情況。

We do have an upcoming DMC meeting in the month of May, where the members will review our masked data, and we look forward to provide updates after that meeting.

我們在 5 月將有一場即將召開的 DMC 會議，屆時委員將審閱我們的盲態資料，我們也期待在會後提供最新進展。

Debanjana Chatterjee, Jones.

Debanjana Chatterjee，Jones。

So what have you seen in the masked safety data set so far? And has anything shifted your expectations going into the DSMB review that is scheduled for late May?

那麼到目前為止，你們在盲態安全性資料集中看到了什麼？而在預計 5 月下旬進行的 DSMB 審查之前，有什麼改變了你們的預期嗎？

Thanks for the question, Debanjana. And we're not commenting on any individual SAEs or AEs. But in total, I would say and repeat what Ramiro has said, what we've seen so far is consistent with what we have seen in the prior four trials. No new safety concerns and no incidents that we haven't seen or expected from before. Again, Ramiro, I don't know if you want to add any more color to what I said.

謝謝你的問題，Debanjana。我們不會評論任何個別的嚴重不良事件（SAE）或不良事件（AE）。但整體而言，我會說並重申 Ramiro 所說的：我們目前看到的結果與先前四項試驗所見一致。沒有新的安全性疑慮，也沒有任何我們以前未見過或未預期的事件。再次請教 Ramiro，我不確定你是否想對我所說的再補充一些細節。

Yes. No, I think just again, to reiterate, safety at EyePoint is paramount. We -- internally, we review the data on an ongoing basis on a masked fashion. And as Jay mentioned, we have no safety signal. We haven't attacked anything that is new. The safety profile continues to be very similar to what we saw in our previous completed studies.

是的。不，我想再次重申，EyePoint 對安全性的重視是首要的。我們——在內部以盲態方式持續審閱資料。如 Jay 所提到的，我們沒有看到安全性訊號。我們沒有遇到任何新的情況。安全性概況仍然與我們先前已完成研究中看到的非常相似。

Just a very quick follow-up. Can we expect any formal public update following the DSMB meeting?

再非常快速追問一下。在 DSMB 會議之後，我們是否可以期待有任何正式的公開更新？

Yes. I think it's likely that we will give an update, yes.

是的。我認為我們很可能會提供更新，是的。

Lisa Walter, RBC Capital Markets.

Lisa Walter，RBC Capital Markets。

Congrats on the progress. We have seen a long-acting TKI competitor had a successful readout of their pivotal study earlier this year. And we've heard their plan is to file with the FDA and seek approval on this trial alone. In a scenario where essentially both, yours and the other long-acting TKI, are being launched within similar time frames, does perhaps having two products with the same mechanism of action actually help break into a market which already has an established therapeutic base with the anti-VEGF? How should we think about this?

恭喜進展順利。我們看到一個長效 TKI 競品今年稍早在其關鍵性研究中取得成功讀出。也聽說他們的計畫是向 FDA 申報，並僅憑這項試驗尋求核准。在一種情境下，基本上你們與另一個長效 TKI 都在相近的時間框架內上市，是否兩個具有相同作用機轉的產品反而有助於切入一個已由抗 VEGF 建立治療基礎的市場？我們應該如何看待這件事？

Yes, Lisa, thanks for the question. It's a great question. And I think you've really hit on a very important point. This is not a zero-sum game. The TKIs are going into a multibillion-dollar market. And there is certainly room for two competitors to both be very successful in this very large market. There is evidence from -- as I think you're alluding to, from other launches with new mechanism of action into an established space that having more than one entry really helps both because doctors are hearing it and learning about it from multiple places.

是的，Lisa，謝謝你的問題。這是個很好的問題。我認為你確實點出了非常重要的一點。這不是零和賽局。TKI 正在進入一個數十億美元規模的市場。而且在這個非常大的市場中，確實有空間讓兩個競爭者都非常成功。正如我想你所暗示的，從其他在既有領域中以新作用機轉上市的案例可見，若有不只一個進入者，往往能同時幫助雙方，因為醫師會從多個來源聽到並學習相關資訊。

So we welcome another competitor. And part of that is we believe we've got a better drug and a better delivery system. And hopefully, if both are FDA approved, well we will have the opportunity from a commercial basis to really show that.

因此我們歡迎另一位競爭者。其中一部分原因是我們相信我們有更好的藥物與更好的給藥系統。並且希望如果兩者都獲得 FDA 核准，從商業角度而言，我們將有機會真正展現這一點。

Nick Quartapella, Baird.

Nick Quartapella，Baird。

It's Nick on for Colleen. So just at ARVO and other recent scientific conferences, just wanted to ask what -- just what the takeaways were on DURAVYU, sentiment among physicians and if you got any learnings about how physicians intend on using DURAVYU upon a potential approval?

我是 Nick，代替 Colleen。所以在 ARVO 以及其他近期科學會議上，我想請教一下——關於 DURAVYU 的主要收穫是什麼、醫師之間的觀感如何，以及你們是否有學到任何關於在潛在核准後醫師打算如何使用 DURAVYU 的資訊？

So one point I'd like to make, and thanks for the question, Nick. One point I'd like to make about ARVO is we had a poster there, which showed another preclinical model of leakage induced by VEGF and IL-6. And in that model, vorolanib, the active ingredient in EYP-1901 was able to suppress the inflammation induced by IL-6 and VEGF equal to an anti-VEGF and an anti-IL-6.

我想先提一點，謝謝你的問題，Nick。關於 ARVO 我想說的是，我們在那裡有一張海報，展示了另一個由 VEGF 與 IL-6 誘發滲漏的臨床前模型。在該模型中，vorolanib（EYP-1901 的活性成分）能夠抑制由 IL-6 與 VEGF 誘發的發炎，其效果相當於一個抗 VEGF 與一個抗 IL-6。

So again, one more model that suggests that vorolanib does have potent anti-IL-6 activity through the JAK1 receptor. There was a lot of interest in that poster. A lot of KOLs saw it, and there were quite a number of comments. Ramiro met with multiple KOLs at ARVO, and I will let him weigh in on what the sentiment seems to be around EYP-1901.

因此，這又是一個模型顯示 vorolanib 透過 JAK1 受體具有強效的抗 IL-6 活性。那張海報引起了很大的興趣。許多 KOL 都看了，也有相當多的評論。Ramiro 在 ARVO 與多位 KOL 會面，我讓他來談談大家對 EYP-1901 的觀感似乎如何。

Yes. No, thanks, Nick, for the question. And we had a very productive ARVO this year with several posters being presented, including the one that Jay just mentioned. We also had a few advisory boards and some interactions with our Phase III wet AMD and DME investigators. I think first on the sentiment of the clinical trials, I think everybody, of course, is very excited for the upcoming data for LUGANO and LUCIA.

是的。不，謝謝你，Nick，提出這個問題。我們今年的 ARVO 非常有收穫，展示了數張海報，包括 Jay 剛提到的那一張。我們也舉辦了幾場諮詢委員會，並與我們第三期濕性 AMD 與 DME 的研究者有一些互動。我想先談臨床試驗的觀感：我認為大家當然都非常期待 LUGANO 與 LUCIA 即將公布的數據。

Mentions are, this is going to be the highlight of the retina space for the year of 2026. For DME, the investigators, again, reflect that this is a really well-studied plan, very patient-centric, and they were all excited about bringing the therapy for patients with DME. In terms of future use of DURAVYU, as Jay mentioned previously in the call, they expressed the important unmet need that we're trying to address with DURAVYU.

提到的是，這將會是 2026 年視網膜領域的年度焦點。就 DME 而言，研究者再次反映，這是一個研究非常充分的方案、非常以病患為中心，他們都很期待把這項療法帶給 DME 病患。至於 DURAVYU 的未來使用，如 Jay 先前在電話會議中提到，他們指出我們正試圖透過 DURAVYU 解決的重要未被滿足需求。

And they see this if we can replicate the results that we saw in the Phase II study as something that is going to be very meaningful for patients, especially for those patients that require frequent treatment.

他們認為，如果我們能夠複製第二期研究中看到的結果，這將對病患非常有意義，特別是對那些需要頻繁治療的病患。

Yale Jen, Laidlaw.

Yale Jen，Laidlaw。

And I just follow up a little bit on the commercial question earlier, which is that besides the TKIs, in terms of the long-acting biologics, VABYSMO and the high-dose Eylea, which one you think you scale really, if approved, will be competing more or less? And any comment on that?

我想就先前的商業化問題再追問一下：除了 TKI 之外，就長效生物製劑而言，VABYSMO 與高劑量 Eylea，你認為若獲核准，哪一個會更具規模、競爭程度會更高或更低？對此有任何評論嗎？

Thanks for the question, Yale. It's an important question because these are excellent medications that are multibillion-dollar drugs that are really helping many, many patients. I think the first point to be clear on is we're not another anti-VEGF biologic. We work at the receptor level. We have multi-MOA block VEGF, PDGF, and we do believe the inflammation related to IL-6 elevation, which is not something that they do.

謝謝你的問題，Yale。這是個重要的問題，因為這些都是非常優秀的藥物，屬於數十億美元級別的藥品，確實正在幫助非常非常多的病患。我認為首先要釐清的一點是：我們不是另一個抗 VEGF 生物製劑。我們是在受體層級發揮作用。我們具備多重作用機制（MOA），可阻斷 VEGF、PDGF，而且我們也相信與 IL-6 升高相關的發炎反應——這是它們做不到的。

In addition, it looks like from our Phase II data that at least 2/3 of the wet AMD population could be treated with our drug alone every six months should physicians choose to do that. That's not something that we're seeing in the real world with those new medications. While there are extended durations, what the real-world data is suggesting that most patients are getting about a week or two extension from either of those drugs compared to what they were on before.

此外，從我們的第二期數據來看，至少有 2/3 的濕性 AMD 族群，若醫師選擇如此治療，可僅用我們的藥物每六個月治療一次。這不是我們在現實世界中從那些新藥看到的情況。雖然治療間隔有所延長，但真實世界數據顯示，多數病患相較於先前用藥，使用這兩種藥物大約只延長一到兩週。

Now that's great, but we still believe that it leaves a lot of room in the market for a six-month or longer medication. I -- it's hard to predict which of those drugs will be -- I don't want to say the winner because I think both drugs are doing well when we launch potentially. But we -- again, our belief is that we can provide benefits greater than what either of those drugs can do for patients.

這當然很好，但我們仍然認為，市場上對於每六個月或更久一次的藥物仍有很大空間。我——很難預測哪一個藥會——我不想說誰是贏家，因為我認為在我們可能上市時，兩個藥都表現得不錯。但我們——再次強調，我們相信我們能為病患帶來超過這兩種藥物所能提供的效益。

And we believe in the long term, we will achieve better visual acuity. Mike Campbell, our Chief Commercial Officer, I believe, is on the line. And I don't know if he's going to maybe have any other comments now. I think it's a little early to talk about commercial strategy. But maybe, Mike, you can talk a little bit about how you view the competition.

而且我們相信，長期而言，我們將能達到更好的視力（視覺敏銳度）。我想我們的首席商務長 Mike Campbell 也在線上。我不確定他現在是否會有其他補充。我認為現在談商業策略還稍早。不過也許，Mike，你可以談談你如何看待競爭態勢。

Yes. Thank you for the question. The one point I would add is that while we have these very good anti-VEGFs, longer-acting anti-VEGFs in the market, not only is the real-world data showing the extension that Jay mentioned around 8 days. We also look at what the retina specialists are saying in the community and where the needs are.

是的。謝謝你的提問。我想補充的一點是：雖然市場上已有這些非常好的抗 VEGF、長效抗 VEGF 藥物，但不僅真實世界數據顯示如 Jay 所提到的延長幅度約 8 天，我們也會看視網膜專科醫師在社群中的回饋，以及需求所在。

And so if you look at the American Society of Retina Specialists, ASRS, every year, they put out a PAT survey. And very consistently, the number one need in wet AMD treatments that is reported from ASRS is still durability even with VABYSMO and Eylea HD in the market. So to Jay's point, there is a very clear opportunity should DURAVYU be successful and be approved, there's a very clear opportunity or room in this market for more durable agents.

因此，如果你看美國視網膜專科醫師學會（ASRS），他們每年都會發布 PAT 調查。而且非常一致地，ASRS 回報的濕性 AMD 治療第一大需求，即使在 VABYSMO 與 Eylea HD 已上市的情況下，仍然是「持久性」（durability）。所以呼應 Jay 的觀點，若 DURAVYU 成功並獲核准，市場上對更具持久性的藥物有非常明確的機會與空間。

Samuel Rollenhagen, TD Cowen.

Samuel Rollenhagen，TD Cowen。

This is Sam on for Tara. Can you hear me?

我是代 Tara 發言的 Sam。你聽得到我嗎？

Yes.

聽得到。

Congrats on another great enrollment update. So I just wanted to ask on safety for the LUGANO data. And if you could help us set some expectations there for what you're hoping to see. I guess, besides avoiding some of the more serious back of the eye events, are there any other AEs where you think DURAVYU could be differentiated versus competitors?

恭喜又一次很棒的入組更新。我想問一下關於 LUGANO 數據的安全性。如果你能幫我們設定一些預期，看看你們希望看到什麼。我想，除了避免一些較嚴重的眼後段事件之外，還有沒有其他不良事件（AE）方面，你們認為 DURAVYU 相較競品可能具差異化？

And then also, it'd just be great if you could clarify how you're anticipating to disclose those safety data in the top line release? Will you be reporting all events or just those above a specific threshold?

另外，也希望你能釐清一下，你們預計在頂線（top line）發布中如何揭露這些安全性數據？你們會報告所有事件，還是只報告高於某個特定門檻的事件？

Thanks for the question, Sam. And so again, the -- one of the hallmarks of the current anti-VEGF approved drugs with perhaps one exception, is they're quite safe. And while patients and physicians will probably be willing to accept perhaps a few more AEs from a long-acting drug, there can't be a big difference. There's really a high bar that's out there for safety.

謝謝你的問題，Sam。因此再次強調，目前已核准的抗 VEGF 藥物（或許有一個例外）的其中一個特徵是：它們相當安全。而且雖然病患與醫師可能願意為長效藥物接受多一些不良事件，但差異不能太大。安全性門檻真的非常高。

And the good news is that all our safety from our four reported trials shows no real increase in any SAE or AE that would preclude our drug from being widely accepted, in our opinion. So from a safety perspective, again, a lot of the safety issues that can occur are injection related. And if you're reducing the number of injections that a patient gets, then you're likely in the long term to have fewer adverse events.

好消息是，我們在四項已報告試驗中的所有安全性結果顯示，並沒有任何嚴重不良事件（SAE）或不良事件（AE）的實質增加，足以在我們看來阻礙藥物被廣泛接受。因此就安全性而言，很多可能發生的安全性問題與注射相關。如果你降低病患接受注射的次數，那麼長期來看，很可能會有更少的不良事件。

We hope to be able to show that in our pivotal trials. And from a reporting perspective, I don't know how granular the safety reporting will be initially, but we do expect to have complete AE tables when we present the data from LUGANO and LUCIA.

我們希望能在關鍵性試驗中證明這一點。至於揭露方式，我不確定一開始安全性報告會細到什麼程度，但我們確實預期在呈現 LUGANO 與 LUCIA 數據時，會提供完整的 AE 表格。

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

目前我看到隊列中沒有其他問題。各位女士、先生，感謝您參與今天的會議。本次會議到此結束，您現在可以斷線。祝各位今天愉快。