EyePoint Pharmaceuticals Inc (EYPT) 2023 Q4 法說會逐字稿

Good morning.

早安.

My name is Kevin, and I'll be your conference operator today.

我叫凱文，今天我將擔任你們的會議操作員。

At this time, I'd like to welcome everyone to the EyePoint Pharmaceuticals' fourth quarter and full-year 2023 financial results and recent corporate developments conference call.

此時此刻，我謹歡迎大家參加 EyePoint Pharmaceuticals 2023 年第四季和全年財務業績以及最近的企業發展電話會議。

(Operator Instructions) Please be advised this call is being recorded at the company's request.

（操作員說明）請注意，本次通話是應公司要求進行錄音的。

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

我現在想將電話轉給 EyePoint Pharmaceuticals 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 Pharmaceuticals' fourth quarter and full-year 2023 financial results and recent corporate developments.

感謝大家參加今天的電話會議，討論 EyePoint Pharmaceuticals 第四季和 2023 年全年財務業績以及最近的公司發展。

With me today is Dr. Jay Duker, President and Chief Executive Officer.

今天與我在一起的是總裁兼執行長 Jay Duker 博士。

And Jay will begin with a review of recent corporate updates and discuss the ongoing clinical trials for EYP-1901.

Jay 將首先回顧最近的公司更新，並討論正在進行的 EYP-1901 臨床試驗。

I will close with commentary on the fourth quarter and full-year 2023 financial results.

最後我將對第四季和 2023 年全年財務表現進行評論。

We will then open the call for your questions.

然後我們將打開電話詢問您的問題。

Earlier this morning, we issued a press release detailing our financial results and recent operational developments.

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營運發展。

A copy of the release can be found in the Investor Relations tab on the corporate website, www.eyepointpharma.com.

新聞稿的副本可以在公司網站 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.

在我們開始發表正式評論之前，我要提醒您，我們今天發表的各種言論均構成前瞻性聲明，旨在遵守 1995 年《私人證券訴訟改革法案》中的安全港條款。

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

其中包括有關我們未來期望、臨床開發和監管事項以及時間表、我們的產品和候選產品的潛在成功、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 may make with the SEC in the future.

由於各種重要因素的影響，實際結果可能與這些前瞻性陳述所表明的結果存在重大差異，包括我們向 SEC 備案的最新 10-K 表格年度報告的風險因素部分中討論的因素，以及我們將來可能向SEC 提交的其他文件中。

Any forward-looking statements represent our views as of today only.

任何前瞻性陳述僅代表我們今天的觀點。

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.

雖然我們可能選擇在未來某個時候更新這些前瞻性陳述，但我們明確表示不承擔任何這樣做的義務，即使我們的觀點改變。

Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.

因此，您不應依賴這些前瞻性陳述來代表我們截至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 Pharmaceuticals.

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

Thank you, George.

謝謝你，喬治。

Good morning, everyone, and thank you for joining us.

大家早安，感謝您加入我們。

2023 was truly an exceptional year for EyePoint Pharmaceuticals on all fronts.

2023 年對於 EyePoint Pharmaceuticals 的各個方面來說確實是不平凡的一年。

We completed our transformation into a clinical stage biopharmaceutical company with the out-license of the YUTIQ franchise last spring for $82.5 million plus future royalties.

去年春天，我們以 8,250 萬美元加上未來的特許權使用費獲得了 YUTIQ 特許經營權，完成了向臨床階段生物製藥公司的轉型。

We advanced our lead pipeline asset, EYP-1901, across three promising indications, wet age-related macular degeneration or wet AMD; non-proliferative diabetic retinopathy, or NPDR; and diabetic macular edema, or DME.

我們推進了我們的主要管道資產 EYP-1901，跨越三個有希望的適應症，濕性老年性黃斑部病變或濕性 AMD；非增殖性糖尿病視網膜病變（NPDR）；和糖尿病黃斑水腫（DME）。

We also significantly strengthened our balance sheet, ending 2023 with $331 million in cash and investments and no debt.

我們也大幅增強了資產負債表，截至 2023 年，我們的現金和投資為 3.31 億美元，沒有債務。

This is driven by the YUTIQ sale and a $230 million oversubscribed follow-on equity offering.

這是由 YUTIQ 出售和 2.3 億美元超額認購的後續股票發行所推動的。

I'd like to review our recent progress for our lead product candidate, EYP-1901, a potentially paradigm-altering treatment for patients suffering from VEGF-mediated retinal diseases.

我想回顧我們的主要候選產品 EYP-1901 的最新進展，這是一種潛在的改變治療 VEGF 介導的視網膜疾病患者治療模式的方法。

In December, we reported positive top-line efficacy and safety data from our Phase 2 DAVIO 2 clinical trial in wet AMD, achieving all primary and secondary end points.

12 月，我們報告了濕性 AMD 2 期 DAVIO 2 臨床試驗的積極頂線療效和安全性數據，實現了所有主要和次要終點。

We expect to initiate the first pivotal Phase 3 wet AMD trial, the LUGANO trial in the second half of this year, with the second pivotal trial called the [LUCIA] trial to follow.

我們預計將在今年下半年啟動第一個關鍵的 3 期濕性 AMD 試驗，即 LUGANO 試驗，隨後將啟動第二個關鍵試驗，稱為 [LUCIA] 試驗。

We also look forward to reporting top line data for the Phase II PAVIA clinical trial in the second quarter of this year and top-line data from the Phase II VERONA trial in the first quarter of 2025.

我們也期待在今年第二季報告 II 期 PAVIA 臨床試驗的頂線數據，以及在 2025 年第一季報告 II 期 VERONA 試驗的頂線數據。

As a reminder, EYP-1901 is an investigational sustained release product that it consists of vorolanib, a selective and patent-protected tyrosine kinase inhibitor, or TKI, formulated in Durasert E, the bio-erodible version of our proprietary Durasert technology.

需要提醒的是，EYP-1901 是一種研究性緩釋產品，由沃羅拉尼（vorolanib）組成，沃羅拉尼是一種選擇性且受專利保護的酪氨酸激酶抑製劑（TKI），採用Durasert E（我們專有的Durasert 技術的生物可蝕版本）配製而成。

Vorolanib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases by acting as a pan-VEGF receptor blocker blocking all VEGF isoforms.

Vorolanib 作為泛 VEGF 受體阻斷劑阻斷所有 VEGF 亞型，為治療 VEGF 介導的視網膜疾病帶來了一種新的機制方法。

In addition to the positive safety and efficacy data reported to date, vorolanib has also demonstrated neuroprotection in a validated retinal detachment animal model.

除了迄今為止所報導的積極的安全性和有效性數據外，沃羅拉尼還在經過驗證的視網膜剝離動物模型中證明了神經保護作用。

Vorolanib may also have an antifibrotic effect as it blocks the PDGF receptor.

Vorolanib 也可能具有抗纖維化作用，因為它會阻斷 PDGF 受體。

EYP-1901 is delivered by an intravitreal injection in the physician's office similar to the current FDA-approved anti-VEGF biologic treatments.

EYP-1901 在醫生辦公室透過玻璃體內注射進行給藥，類似於目前 FDA 批准的抗 VEGF 生物治療。

Unlike currently approved biologics and other sustained-release anti-VEGFs and development, EYP-1901 is shipped and stored at ambient temperature.

與目前批准的生物製劑和其他緩釋抗 VEGF 藥物和開發不同，EYP-1901 在環境溫度下運輸和儲存。

Additionally, vorolanib through Durasert E is immediately bioavailable in the eye, featuring an initial burst of drug followed by our near constant zero-order kinetic release for up to nine months.

此外，vorolanib 透過 Duraset E 在眼中可立即產生生物利用度，其特點是藥物最初爆發，然後是近乎恆定的零級動力學釋放長達九個月。

Our goal is to provide a product that maintains stable vision and retinal anatomy for the majority of wet AMD patients within every six-month label.

我們的目標是提供一種產品，在每六個月的標籤內為大多數濕性 AMD 患者保持穩定的視力和視網膜解剖結構。

This could represent a significant improvement compared to the current anti-VEGF treatments that are dosed on average every two months in the United States, and this may allow patients and practitioners the flexibility to reduce the number of visits without sacrificing visual outcomes.

與目前美國平均每兩個月進行一次的抗 VEGF 治療相比，這可能代表顯著的進步，這可能使患者和醫生能夠靈活地減少就診次數，而不犧牲視力結果。

Turning to the Phase II DAVIO 2 non-inferiority clinical trial evaluating EYP-1901 in previously treated with AMD patients as a potential maintenance therapy, all primary and secondary endpoints were achieved in this trial, including a statistically noninferior change in best corrected visual acuity or BCVA, versus the aflibercept control for both EYP-1901 arms.

轉向II 期DAVIO 2 非劣效性臨床試驗，評估EYP-1901 在既往接受過AMD 治療的患者中作為潛在的維持治療，該試驗中實現了所有主要和次要終點，包括最佳矯正視力或視力的統計學非劣性變化。

Non-inferiority change in BCVA is the most commonly used endpoint in wet AMD pivotal trials and subsequent FDA approval.

BCVA 的非劣效性變化是濕性 AMD 關鍵試驗和隨後 FDA 批准中最常用的終點。

Importantly, EYP-1901 continued to demonstrate a favorable safety profile with no EYP-1901 related ocular or systemic serious adverse events or SAEs reported.

重要的是，EYP-1901 繼續表現出良好的安全性，沒有報告 EYP-1901 相關的眼部或全身嚴重不良事件或 SAE。

We also saw an over 80% reduction in treatment burden measured both prospectively and retrospectively with strong anatomical control in both EYP-1901 cohorts.

我們還發現，在兩個 EYP-1901 隊列中，透過強有力的解剖學控制，前瞻性和回顧性測量的治療負擔減少了 80% 以上。

At the Angiogenesis Meeting in February, investigators reported that a subgroup of DAVIO 2 patients remained anti-VEGF supplement free up to six months after delivery of EYP-1901.

在 2 月的血管生成會議上，研究人員報告稱，DAVIO 2 患者的一個亞組在接受 EYP-1901 後六個月內仍無需服用抗 VEGF 補充劑。

This subgroup demonstrated numerical superiority in change in BCVA along with strong anatomical control compared to the aflibercept control group.

與阿柏西普對照組相比，該亞組表現出 BCVA 變化的數值優勢以及強大的解剖學控制。

This result confirms that the positive top line data from the Phase 2 DAVIO 2 trial were driven by EYP-1901 and not by supplemental injections.

這項結果證實了 2 期 DAVIO 2 試驗的陽性頂線數據是由 EYP-1901 驅動的，而不是由補充注射驅動的。

We anticipate initiating the LUGANO Phase 3 trial in wet AMD in the second half of 2024 and the second pivotal trial, LUCIA, several months after.

我們預計將於 2024 年下半年啟動濕性 AMD 的 LUGANO 3 期試驗，並在幾個月後啟動第二個關鍵試驗 LUCIA。

The Phase 2 DAVIO 2 trial EYP-1901 was designed to mirror the anticipated design of the Phase 3 trials based on our Type C meeting with the FDA as well as other interactions.

2 期 DAVIO 2 試驗 EYP-1901 旨在反映基於我們與 FDA 的 C 型會議以及其他相互作用的 3 期試驗的預期設計。

The key differences between DAVIO 2 in the Phase 3 trials are that we anticipate the Phase 3 will feature redosing of EYP-1901 every six months, the primary efficacy endpoint will be non-inferior change in BCVA at approximately one year, and the two EYP-1901 arms will be one or two inserts versus the two and three inserts used in DAVIO 2.

DAVIO 2 在 3 期試驗中的主要區別在於，我們預計 3 期試驗將以每六個月重新服用 EYP-1901 為特色，主要療效終點將是大約一年時 BCVA 的非劣性變化，並且兩個 EYP -1901 臂將是一個或兩個插入件，而DAVIO 2 中使用的是兩個和三個插入件。

The decision to use one versus two inserts in the Phase 3 trials is driven by the positive DAVIO 2 data for both the 2-milligram and the 3-milligram doses.

在 3 期試驗中使用 1 與 2 插入物的決定是由 2 毫克和 3 毫克劑量的 DAVIO 2 陽性數據驅動的。

The LUGANO Phase 3 trial will be conducted largely in the US, and the LUCIA Phase 3 trial will include US and ex-US sites as we intend to seek EMA approval.

LUGANO 3 期試驗將主要在美國進行，LUCIA 3 期試驗將包括美國和美國以外的地點，因為我們打算尋求 EMA 批准。

We look forward to reviewing our plans at the end of Phase 2 meeting with the FDA in April, and we expect to provide updates after those meeting minutes are received.

我們期待在 4 月與 FDA 舉行的第二階段會議結束時審查我們的計劃，並希望在收到這些會議記錄後提供最新情況。

As I mentioned earlier, we are on track to report top line data from the Phase 2 PAVIA trial in 2Q of this year.

正如我之前提到的，我們預計在今年第二季報告 PAVIA 2 期試驗的主要數據。

PAVIA is a randomized controlled trial evaluated EYP-1901 as a potential nine-month treatment for moderately severe to severe NPDR.

PAVIA 是一項隨機對照試驗，評估 EYP-1901 作為中重度至重度 NPDR 的潛在 9 個月治療方法。

The trial enrolled 77 patients who are randomly assigned to one of two doses of EYP-1901 or to the control group that received a sham injection.

該試驗招募了 77 名患者，他們被隨機分配到兩劑 EYP-1901 中的一劑或接受假注射的對照組。

There remains a great unmet need for a safe, efficacious, and convenient treatment for NPDR that proactively reduces the risk of progressing to sight-threatening complications over the long term.

對於 NPDR 的安全、有效和方便的治療方法仍然存在巨大的未滿足的需求，這種治療方法可以主動降低長期進展為威脅視力的併發症的風險。

Approximately 90% of patients with NPDR received no course of treatment apart from observation by their eye doctors until their disease progresses to DME and, or proliferative diabetic retinopathy.

大約 90% 的 NPDR 患者除了眼科醫師的觀察外沒有接受任何治療，直到他們的疾病進展為 DME 和/或增殖性糖尿病視網膜病變。

This is because the approved treatments are short acting and therefore, require frequent injections.

這是因為核准的治療方法作用時間短，因此需要頻繁注射。

We believe EYP-1901 could potentially create a new market for NPDR patients by providing an every nine-month treatment option that matches the patient's visit cadence.

我們相信 EYP-1901 可以透過提供與患者就診節奏相符的每九個月一次的治療選擇，為 NPDR 患者創造一個新市場。

In the PAVIA trial, the primary endpoint is structural.

在 PAVIA 試驗中，主要終點是結構性的。

A photograph of the retina is taken on day one of the study and then compared to a photograph taken at month nine.

在研究的第一天拍攝視網膜照片，然後與第九個月拍攝的照片進行比較。

A reading center independently evaluates the photographs to assess the degree of retinopathy on the diabetic retinopathy severity scale, abbreviated the DRSS.

閱讀中心獨立評估這些照片，以評估糖尿病視網膜病變嚴重程度量表（縮寫為 DRSS）的視網膜病變程度。

The DRSS is a well-validated measure that correlates the functional with the anatomic outcomes.

DRSS 是一種經過充分驗證的測量方法，可將功能與解剖結果相關聯。

The accepted clinically relevant step change demonstrates a two-step reduction in the scale.

公認的臨床相關步驟變化顯示規模有兩步減少。

In the PAVIA trial, we are looking for at least one-third of the patients to show a greater than or equal to two-step reduction on the DRSS scale at nine months.

在 PAVIA 試驗中，我們正在尋找至少三分之一的患者在 9 個月時 DRSS 量表顯示出大於或等於兩步驟的減少。

It's important to note that this is a lower limit and not an expectation.

值得注意的是，這是一個下限，而不是一個期望。

We will also be looking at important secondary endpoints, including reduction in vision-threatening complications, prevention of DME and proliferative diabetic retinopathy, degree of retinal ischemia and safety.

我們還將關注重要的次要終點，包括減少威脅視力的併發症、預防 DME 和增殖性糖尿病視網膜病變、視網膜缺血程度和安全性。

Consistent with our results to date for this program, we expect to see a continued favorable safety profile, a critical factor in any retinal drug.

與我們迄今為止該計劃的結果一致，我們預計將看到持續良好的安全性，這是任何視網膜藥物的關鍵因素。

Turning to our third indication.

轉向我們的第三個跡象。

In January, we initiated the Phase 2 VERONA trial evaluating EYP-1901 in a second diabetic eye disease indication, DME, a sight-threatening complication of diabetes that can lead to severe visual loss.

一月份，我們啟動了 2 期 VERONA 試驗，評估 EYP-1901 在第二種糖尿病眼疾適應症 DME 中的作用，DME 是一種威脅視力的糖尿病併發症，可導致嚴重視力喪失。

Similar to wet AMD, this is a VEGF-mediated disease where there is a significant need for differentiated and longer-acting treatments.

與濕性 AMD 類似，這是一種 VEGF 介導的疾病，非常需要差異化和長效的治療。

VERONA is a randomized controlled single mass Phase 2 trial of EYP-1901 in DME patients previously treated with standard of care anti-VEGF therapy.

VERONA 是 EYP-1901 的隨機對照單質量 2 期試驗，受試者為先前接受過標準抗 VEGF 治療的 DME 患者。

The three-arm trial is expected to enroll approximately 25 patients randomized to one of two doses of EYP-1901 or an aflibercept control.

這項三組試驗預計將招募約 25 名患者，隨機接受兩劑 EYP-1901 或阿柏西普對照劑中的一劑。

The primary efficacy endpoint of the VERONA trial is time to first anti-VEGF supplement up to 24 weeks based on established criteria.

VERONA 試驗的主要療效終點是根據既定標準，首次服用抗 VEGF 補充劑長達 24 週的時間。

Secondary endpoints include safety, change in BCVA, change in central subfield thickness as measured on OCT, and change in DRSS over time.

次要終點包括安全性、BCVA 變化、OCT 測量的中心子場厚度變化以及 DRSS 隨時間的變化。

We remain on track to report top-line data from the VERONA trial in the first quarter of 2025.

我們仍有望在 2025 年第一季報告 VERONA 試驗的主要數據。

We remain highly encouraged by the growing body of positive clinical data for EYP-1901, and we are optimistic that EYP-1901 is the potential to change the current treatment paradigm for VEGF-mediated retinal diseases.

我們對 EYP-1901 不斷增長的陽性臨床數據感到高度鼓舞，並且我們樂觀地認為 EYP-1901 有潛力改變目前 VEGF 介導的視網膜疾病的治療模式。

Turning to our pipeline programs.

轉向我們的管道計劃。

We announced a new preclinical program, EYP-2301, which delivers a promising TIE-2 agonist, razuprotafib, formerly known as AKB-9778, formulated in Durasert E. Razuprotafib is an inhibitor of vascular endothelial protein tyrosine phosphatase, or VE-PTP.

我們宣布了一項新的臨床前計劃EYP-2301，該計劃提供一種有前途的TIE-2 激動劑razuprotafib（以前稱為AKB-9778），採用Durasert E 配製。磷酸酶（VE-PTP）的抑制劑。

We believe that delivering EYP-2301 intravitreally has the potential to offer new site-saving treatment for patients with severe retinal disease, either alone or in combination with anti-VEGFs.

我們相信，玻璃體內注射 EYP-2301 有可能為患有嚴重視網膜疾病的患者提供新的位點保留治療，無論是單獨使用還是與抗 VEGF 藥物聯合使用。

We continue to evaluate additional molecules for sustained delivery in Durasert E, including complement inhibition and rare diseases and hope to update you on these programs later this year.

我們將繼續評估 Duraset E 中持續遞送的其他分子，包括補體抑制和罕見疾病，並希望在今年稍後向您通報這些項目的最新情況。

Last, I'm delighted to welcome Ramiro Ribeiro, MD, PhD, to EyePoint as our new Chief Medical Officer.

最後，我很高興歡迎 Ramiro Ribeiro 醫學博士加入 EyePoint，擔任我們新任首席醫療官。

Dr. Ribeiro was a trained retinal specialist who joins us from Apellis Pharmaceuticals, where he served as Vice President, Head of Clinical Development and we're confident that his proven leadership and strong scientific and clinical background will be a tremendous asset to the EyePoint team.

Ribeiro 博士是一位訓練有素的視網膜專家，在加入我們之前曾在Apellis Pharmaceuticals 擔任副總裁兼臨床開發主管，我們相信他久經考驗的領導能力以及強大的科學和臨床背景將成為EyePoint 團隊的巨大財富。

I'd like to thank Dr. Dario Paggiarino, who served as our Chief Medical Officer for the past seven years.

我要感謝過去七年擔任我們首席醫療官的 Dario Paggiarino 博士。

To close, I want to thank the entire EyePoint team for an incredible 2023 and a strong start in 2024.

最後，我要感謝整個 EyePoint 團隊，感謝他們帶來了令人難以置信的 2023 年和 2024 年的強勁開局。

The impressive execution and dedication demonstrated by our team to reach these milestones reflects the entire organization's commitment to patients.

我們的團隊為實現這些里程碑所表現出的令人印象深刻的執行力和奉獻精神反映了整個組織對病人的承諾。

In addition, I'd like to thank the patients and clinical investigators for their participation in the ongoing trials.

此外，我還要感謝患者和臨床研究人員參與正在進行的試驗。

Without you all, the progress we've made advancing EYP-1901 would not be possible.

沒有你們大家，我們就不可能在 EYP-1901 方面取得進展。

With our compelling clinical pipeline representing potential multibillion-dollar product opportunities, our best-in-class sustained ocular delivery Durasert E technology, along with a strong balance sheet, we're well positioned to grow as a leader in ocular drug delivery and to bring impactful therapies to patients suffering from serious retinal diseases.

憑藉我們引人注目的臨床管道代表了潛在的數十億美元的產品機會、我們一流的持續眼部給藥Durasert E 技術以及強大的資產負債表，我們處於有利地位，能夠成長為眼部藥物輸送領域的領導者，並帶來對患有嚴重視網膜疾病的患者進行有效的治療。

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

我現在將把電話轉給喬治來審查財務狀況。

George?

喬治？

Thank you, Jay.

謝謝你，傑伊。

Before we review the financial results, 2023 was an exceptional year for our financial performance.

在我們回顧財務表現之前，2023 年對於我們的財務表現來說是非同尋常的一年。

As Jay noted, we ended '23 with a strong balance sheet driven by the out-license of YUTIQ, the retirement of outstanding bank debt and an oversubscribed $230 million follow-on financing in December, resulting in $331 million of cash and investments at December 31.

正如Jay 指出的那樣，我們在23 年結束時擁有強勁的資產負債表，這得益於YUTIQ 的外發許可、未償銀行債務的清償以及12 月份超額認購的2.3 億美元後續融資，從而在12月份帶來了3.31 億美元的現金和投資31.

As the financial results for the three months and full year ended December 31, 2023, were included in the press release issued this morning, my comments today will be focused on a high-level review for the quarter.

由於截至 2023 年 12 月 31 日的三個月和全年財務業績已包含在今天上午發布的新聞稿中，因此我今天的評論將集中於該季度的高層審查。

For the quarter ended December 31, 2023, total net revenue was $14 million compared to $10.5 million for the quarter ended December 31, 2022.

截至 2023 年 12 月 31 日的季度，總淨收入為 1,400 萬美元，而截至 2022 年 12 月 31 日的季度為 1,050 萬美元。

Net product revenue for the quarter ended December 31, 2023, was $0.7 million compared to net product revenue for the quarter ended December 31, 2022, of $9.9 million.

截至 2023 年 12 月 31 日的季度產品淨收入為 70 萬美元，而截至 2022 年 12 月 31 日的季度產品淨收入為 990 萬美元。

This decrease in net product revenue resulted from our strategic exit from the commercial business in the first half of 2023 and highlighted by the out-license of YUTIQ in May.

產品淨收入的下降是由於我們在 2023 年上半年策略性地退出商業業務，尤其是 5 月份 YUTIQ 的向外許可。

Net revenue from royalties and collaboration for the quarter ended December 31, 2023, totaled $13.3 million compared to $0.6 million in the corresponding period in 2022.

截至 2023 年 12 月 31 日的季度，來自版稅和合作的淨收入總計 1,330 萬美元，而 2022 年同期為 60 萬美元。

The increase was primarily due to partial recognition of deferred revenue from the license of the YUTIQ franchise which began in the second quarter of 2023 and will be recognized over a two-year period in connection with the delivery of YUTIQ supply units.

這一增長主要是由於部分確認了 YUTIQ 特許經營許可的遞延收入，該特許經營權於 2023 年第二季度開始，並將在與 YUTIQ 供應單元交付相關的兩年期內確認。

Operating expenses for the quarter ended December 31, 2023, totaled $30.4 million compared to $54.3 million in the prior year period.

截至 2023 年 12 月 31 日的季度營運費用總計 3,040 萬美元，而去年同期為 5,430 萬美元。

This decrease was primarily driven by the strategic exit from the commercial business in the first half of 2023 and a onetime intangible asset impairment charge in the fourth quarter of 2022.

這一下降主要是由於 2023 年上半年策略性退出商業業務以及 2022 年第四季一次性無形資產減損支出所致。

Non-operating income totaled $2.3 million and net loss was $14.1 million or $0.33 per share loss, compared to a net loss of $43.5 million or $1.16 per share loss for the prior year period.

非營業收入總計 230 萬美元，淨虧損為 1,410 萬美元，即每股虧損 0.33 美元，而上年同期淨虧損為 4,350 萬美元，即每股虧損 1.16 美元。

Turning to the full year ended December 31, 2023.

轉向截至 2023 年 12 月 31 日的全年。

Total net revenue was $46 million compared to $41.4 million for the year ended December 31, 2022.

總淨收入為 4,600 萬美元，而截至 2022 年 12 月 31 日的年度淨收入為 4,140 萬美元。

Net product revenue for the full year ended December 31, '23 was $14.2 million compared to net product revenues for the full year ended December 31, 2022, of $39.9 million.

截至2023年12月31日的全年產品淨收入為1,420萬美元，而截至2022年12月31日的全年產品淨收入為3,990萬美元。

Net revenue from royalties and collaborations for the full year ended December 31, 2023, totaled $31.8 million compared to $1.5 million in the corresponding period in 2022.

截至 2023 年 12 月 31 日止的全年，來自版稅和合作的淨收入總計 3,180 萬美元，而 2022 年同期為 150 萬美元。

Operating expenses for the full year ended December 31, 2023, totaled $121.1 million versus $141 million in the prior year period.

截至 2023 年 12 月 31 日的全年營運費用總計 1.211 億美元，而去年同期為 1.41 億美元。

Net non-operating expense totaled $4.4 million, and net loss was $70.8 million or $1.82 per share, compared to a net loss of $102.3 million or $2.74 per share for the prior year period.

淨非營運費用總計 440 萬美元，淨虧損為 7,080 萬美元，即每股 1.82 美元，而去年同期淨虧損為 1.023 億美元，即每股 2.74 美元。

Cash and investments in marketable securities on December 31, 2023, totaled $331.1 million compared to $144.6 million as of December 31, 2022.

截至 2023 年 12 月 31 日，現金及有價證券投資總額為 3.311 億美元，截至 2022 年 12 月 31 日為 1.446 億美元。

We expect the cash and investments on December 31, 2023, will fund us through top-line data for the planned Phase 3 clinical trials of EYP-1901 for wet AMD in 2026.

我們預計 2023 年 12 月 31 日的現金和投資將透過頂線數據為我們計劃於 2026 年進行的 EYP-1901 治療濕性 AMD 的 3 期臨床試驗提供資金。

This also includes completion of the ongoing Phase 2 clinical trials for EYP-1901 in wet AMD, NPDR, and DME.

這也包括完成正在進行的 EYP-1901 治療濕性 AMD、NPDR 和 DME 的 2 期臨床試驗。

In conclusion, we are pleased with EyePoint's progress in 2023 and are well capitalized to advance our product pipeline to key value inflection points.

總而言之，我們對 EyePoint 在 2023 年的進展感到滿意，並且有充足的資本將我們的產品線推進到關鍵價值轉折點。

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

現在，我將把電話轉回給傑伊，讓其結束語。

Thank you, George.

謝謝你，喬治。

As we discussed, EyePoint is a story of execution and positive data.

正如我們所討論的，EyePoint 是一個執行力和正向數據的故事。

We've accomplished our clinical milestones efficiently and on track with our guidance, and we plan to continue this track record in 2024 and beyond.

我們已經有效率地實現了我們的臨床里程碑，並在我們的指導下步入正軌，我們計劃在 2024 年及以後繼續保持這一記錄。

Key upcoming catalysts include top line data from our Phase 2 PAVIA clinical trial in the second quarter of 2024, an end of Phase 2 meeting with the US FDA in April, an initiation of the first non-inferiority pivotal Phase 3 LUGANO trial of EYP-1901 in wet AMD in the United States in the second half of this year, enrollment completion of the Phase 2 VERONA clinical trial of EYP-1901 and DME with top-line data expected in the first quarter of 2025, and earlier-stage pipeline program advancement towards clinical development.

即將到來的關鍵催化劑包括 2024 年第二季 PAVIA 2 期臨床試驗的頂線數據、4 月與美國 FDA 舉行的 2 期會議結束、EYP 的第一個非劣效性關鍵 3 期 LUGANO 試驗的啟動1901今年下半年在美國用於濕性AMD，EYP-1901和DME的2期VERONA臨床試驗完成入組，預計2025年第一季獲得頂線數據，以及早期管道計劃臨床開發取得進展。

This remains an incredibly exciting time for EyePoint as we are well positioned to execute on our upcoming milestones and continue to transform the treatment landscape with innovative long-term solutions to improve both the vision and the lives of patients with serious retinal diseases.

對於EyePoint 來說，這仍然是一個令人難以置信的激動人心的時刻，因為我們有能力執行即將到來的里程碑，並繼續透過創新的長期解決方案改變治療格局，以改善患有嚴重視網膜疾病的患者的視力和生活。

Thank you very much for listening this morning.

非常感謝您今天早上的收聽。

I will now turn it over to the operator for questions.

我現在將其交給接線員詢問。

(Operator Instructions) Tessa Romero, JP Morgan.

（操作員指令）Tessa Romero，摩根大通。

Hello, good morning.

你好早安。

Thanks for taking our question.

感謝您提出我們的問題。

As you think about the potential opportunity for EYP-1901, are you able to provide a little bit of further context around how you think about further segmenting the NPDR population?

當您思考 EYP-1901 的潛在機會時，您是否能夠提供一些關於您如何考慮進一步細分 NPDR 人群的進一步背景資訊？

And out of the 6 million NPDR patients here in the US, which patients do you see as the more low-hanging fruit for potential therapy?

在美國 600 萬名 NPDR 患者中，您認為哪些患者更容易獲得潛在治療？

Thank you.

謝謝。

Thank you, Tess.

謝謝你，苔絲。

Before I get to the answer, I'd just like to take this opportunity to introduce our new CMO, Dr. Ramiro Ribeiro, who's here with George and I this morning.

在給出答案之前，我想藉此機會介紹一下我們的新任首席行銷長拉米羅·裡貝羅 (Ramiro Ribeiro) 博士，他今天早上與喬治和我一起來到這裡。

Thanks, Jay.

謝謝，傑伊。

First, I want to say that I'm very privileged to join the EyePoint team.

首先，我想說，我非常榮幸能夠加入 EyePoint 團隊。

I'm a retina specialist by training.

我是一名受過訓練的視網膜專家。

After working private practice, I moved to the US as part of my PhD program where I really fell in love with research.

在完成私人診所工作後，我搬到了美國，作為我的博士課程的一部分，在那裡我真正愛上了研究。

After some time in academic setting, I transition to biotech, mainly small biotech, but always in ophthalmology.

在學術環境中待了一段時間後，我轉向生物技術，主要是小型生物技術，但總是在眼科。

I spent time at Ophthotech during the Fovista trial for wet AMD at Acucela doing a stagger disease.

在 Acucela 進行濕性 AMD 的 Fovista 試驗期間，我在 Ophthotech 度過了一段時間，研究了一種交錯疾病。

And recently, I was the Head of Clinical Development at Apellis, where I led the clinical team from the inception of the Phase 3 protocol, execution of the global trials, regulatory submission, and last year, the approval of SYFOVRE, the first therapy for GA.

最近，我擔任 Apellis 的臨床開發主管，領導臨床團隊從 3 期方案的啟動、全球試驗的執行、監管提交，到去年批准第一個治療藥物 SYFOVRE GA。

I joined EyePoint for three reasons.

我加入 EyePoint 的原因有三。

First, because I believe in the technology that will bring options for patients with data conditions.

首先，因為我相信這項技術將為有數據狀況的患者帶來選擇。

Second, the strong and very cohesive results from DAVIO 2.

其次，DAVIO 2 的強大且非常有凝聚力的結果。

And lastly, the retina community is very small and EyePoint has a reputation of being a strong scientific company.

最後，視網膜領域規模非常小，而 EyePoint 被譽為實力雄厚的科學公司。

And now, we put patients in the first place.

現在，我們把患者放在第一位。

Jay?

傑伊？

Thanks, Ramiro.

謝謝，拉米羅。

And Tess, back to your question, I think the obvious answer is that eyes that have the most severe NPDR are the logical first group that clinicians might treat because those are eyes that have high risk to go on to sight-threatening complications like DME, NPDR.

Tess，回到你的問題，我認為顯而易見的答案是，具有最嚴重NPDR 的眼睛是臨床醫生可能治療的第一組合乎邏輯的眼睛，因為這些眼睛有很高的風險繼續出現威脅視力的並發症，如DME， NPDR。

By preventing or at least delaying significantly the advancement of to those sight-threatening complications, using EYP-1901 potentially once every nine months approximately, we think we can really improve patients' lives by preventing visual loss and preventing the eventual need for multiple injections over years.

透過預防或至少顯著延遲那些威脅視力的併發症的進展，大約每九個月使用一次 EYP-1901，我們認為我們可以透過預防視力喪失並防止最終需要多次注射來真正改善患者的生活。 。

Tyler Van Buren, Cowen.

泰勒·範布倫，考恩。

Great.

偉大的。

Thanks.

謝謝。

Good morning.

早安.

Great.

偉大的。

Congratulations on all the progress during the quarter.

恭喜本季取得的所有進展。

For the planned end of Phase 2 meeting with the FDA next month regarding your Phase 3 plans, can you elaborate on the key discussion topics?

對於計劃於下個月與 FDA 就第三階段計劃舉行的第二階段會議，您能否詳細說明關鍵討論主題？

And to what extent you discussed your development strategy prior to initiating DAVIO 2 as we think about the interactions you've already had with the FDA?

當我們考慮您已經與 FDA 進行的互動時，您在啟動 DAVIO 2 之前在多大程度上討論了您的開發策略？

Yeah.

是的。

Thanks, Tyler.

謝謝，泰勒。

So the second part of your question, I think I'll answer first, which is the sharing and discussion of our development plans with the FDA.

所以你問題的第二部分，我想我會先回答，這是我們與 FDA 分享和討論我們的開發計畫。

As we've said in the past, there was considerable discussion within the company and with the agency several years ago to go straight from our Phase 1 DAVIO trial into pivotal trials in wet AMD.

正如我們過去所說，幾年前，公司內部以及與該機構進行了大量討論，以直接從我們的第一階段 DAVIO 試驗進入濕 AMD 的關鍵試驗。

As a result of that discussion, we had a Type C meeting with the FDA and further discussion after the Type C meeting.

討論的結果，我們與 FDA 舉行了 C 型會議，並在 C 型會議後進行了進一步討論。

At which point, the agency in the company had reached a general, let's call it an agreement over the protocol for potential Phase 3.

此時，公司內部機構就潛在的第三階段協議達成了共識，我們稱之為協議。

We then made the strategic decision to do a more, I'd say, traditional Phase 2 program prior to the Phase 3.

然後我們做出了戰略決策，在第三階段之前進行一個更傳統的第二階段計劃。

Of course, that was the DAVIO 2 program.

當然，那是 DAVIO 2 程式。

And we took the agency's advice instructions, learnings from the end of Phase 2 meeting and subsequent communications and developed the protocol for DAVIO 2 out of those discussions.

我們採納了該機構的建議指示、第二階段會議結束時的經驗教訓以及隨後的溝通，並根據這些討論制定了 DAVIO 2 協議。

And therefore, we're optimistic in, I'd say, going into the end of Phase 2 meeting confident about most of the large touch points around our pivotal trial design.

因此，我想說，我們對進入第二階段會議結束時感到樂觀，並對我們關鍵試驗設計的大多數大型接觸點充滿信心。

So you -- in the first part of the question, you asked about key topics.

所以你——在問題的第一部分，你問了一些關鍵主題。

I'm not sure that I can point to anything in particular is a key topic.

我不確定我是否可以指出任何特別的關鍵主題。

We're going to, again, see general agreement on a non-inferiority trial with a minus 4.5% non-inferiority margin.

我們將再次看到非劣效性試驗的普遍共識，非劣效性幅度為 -4.5%。

All of this is kind of standard and was restated clearly in the draft guidelines.

所有這些都是一種標準，並在指南草案中得到了明確的重申。

So I'm not sure those kind of issues really bubble up to the use of the term key.

所以我不確定這些問題是否真的會因為使用術語“密鑰”而產生。

We have some other questions around some inclusion, exclusion criteria, which we may, hopefully, be made clear in the meeting.

我們還有一些關於某些納入、排除標準的其他問題，希望我們可以在會議中明確這些問題。

And also some issues around the safety cohort that we need to show the FDA.

我們還需要向 FDA 展示一些有關安全隊列的問題。

But again, I'm optimistic that these will all be straightforward and relatively simple for the agency and us to come to an agreement on.

但我再次樂觀地認為，對於該機構和我們來說，這些都將是簡單且相對簡單的達成協議。

Yatin Suneja, Guggenheim.

亞汀‧蘇內賈 (Yatin Suneja)，古根漢。

Hey, guys.

大家好。

Thank you for taking my question.

謝謝你回答我的問題。

Quick one for me, which is more of a clarification on NPDR.

對我來說，這更像是對 NPDR 的澄清。

Jay, you've talked about that if you see about 30%, 35% response rate there, you move forward.

Jay，你說過，如果你看到 30%、35% 的回覆率，你就可以繼續前進。

But if you look at the data from VEGFs, they are in the 45% to 50% range.

但如果你看 VEGF 的數據，你會發現它們在 45% 到 50% 的範圍內。

So just curious like what you heard from the community, like why you move forward at that level.

所以只是好奇你從社區聽到的消息，比如你為什麼在那個級別前進。

And then also in this particular study, are you also looking at the BCVA?

然後，在這項特定的研究中，您是否也關注 BCVA？

I apologize if you already commented on that, but curious to understand how the BCVA dynamic should be measured and what the expectation there are.

如果您已經對此發表評論，我深表歉意，但我很想了解 BCVA 動態應該如何衡量以及期望是什麼。

Sure, Yatin.

當然，雅廷。

Thanks for the questions.

感謝您的提問。

So that kind of floor, I would say, for step improvement in the DRSS for NPDR trial is really based on what many of the KOLs and doctors in the community have told us that if our drug is safe and effective and can be dosed perhaps every nine months, they would use it in a considerable number of their NPDR patients if there was even a 1 out of 3 rate of improvement.

因此，我想說，對於 NPDR 試驗的 DRSS 的逐步改進，這種底線實際上是基於社區中許多 KOL 和醫生告訴我們的，如果我們的藥物安全有效，並且可以每天服用一次，九個月後，即使有三分之一的改善率，他們也會在相當多的NPDR 患者中使用它。

The rate of improvement that the current approved therapy show 50%, 60%, 70%, I have to say it's great, but it's almost irrelevant because they have to be given so frequently that practitioners and patients really are to a large degree, participate.

目前批准的療法顯示出50%、60%、70%的改善率，我不得不說這很棒，但這幾乎無關緊要，因為它們必須如此頻繁地給予，以至於從業者和患者確實在很大程度上參與。

The other thing about NPDR, while there isn't an immediate feedback with a biomarker to the clinician as to whether your drug is working or not, the clinicians are able over time to re-evaluate the degree of diabetic retinopathy in the eye and make their assessment in the office of whether that patient is benefiting from the therapy or isn't.

關於 NPDR 的另一件事是，雖然臨床醫生無法立即透過生物標記回饋您的藥物是否有效，但隨著時間的推移，臨床醫生能夠重新評估眼睛糖尿病視網膜病變的程度，並做出決定。在辦公室評估患者是否從治療中受益。

So if you have a safe, effective bioerodable therapy, and it isn't working, then the clinicians could simply not repeat it.

因此，如果您有一種安全、有效的生物可蝕療法，但它不起作用，那麼臨床醫生就不能重複它。

So we do think that we're going to be able to work with the community to find the best patients for the treatment and help them decide whether continued treatment is in the patient's best interest.

因此，我們確實認為我們將能夠與社區合作，找到最適合治療的患者，並幫助他們決定繼續治療是否符合患者的最大利益。

As for BCVA, it's not a primary endpoint.

至於 BCVA，它不是主要終點。

Most of these NPDR patients have relatively good best corrected visual acuity.

這些NPDR患者大多數具有較好的最佳矯正視力。

And NPDR in and of itself, unless there's quite a bit of macular ischemia involved in it, typically retain good vision.

NPDR 本身，除非涉及相當多的黃斑缺血，通常會保留良好的視力。

So it's something that we were obviously be measuring, but we don't expect significant changes in BCVA in either the treatment or the control arms.

因此，這顯然是我們正在測量的東西，但我們預計治療組或對照組的 BCVA 不會發生顯著變化。

Jennifer Kim, Cantor Fitzgerald.

珍妮佛金，康托費茲傑拉。

Yeah, thanks for taking my question.

是的，謝謝你回答我的問題。

And Dr. Ribeiro, glad to see another retina guy on the team.

Ribeiro 博士很高興看到團隊中又一位視網膜專家。

Maybe to touch up on the -- follow-up the last question.

也許是為了補充最後一個問題的後續。

Since NPDR is around the corner, what do you think is the most important read through from the NPDR study to the DME study given the differences in the end points and the payload of the inserts and the different duration of therapy?

由於 NPDR 即將到來，考慮到終點和插入物有效負荷的差異以及不同的治療持續時間，您認為從 NPDR 研究到 DME 研究最重要的解讀是什麼？

And I guess, ultimately, what kind of profile or other market dynamics are you assuming when you talk about modeling a potential like $1 billion plus opportunity in DR and DME?

我想，最終，當您談論對 DR 和 DME 等 10 億美元以上的潛力進行建模時，您會假設什麼樣的概況或其他市場動態？

Thanks.

謝謝。

Thanks, Jennifer.

謝謝，珍妮佛。

So I think the number-one read through is up until the PAVIA trial, we hadn't dosed EYP-1901 in a diabetic population.

因此，我認為最重要的是直到 PAVIA 試驗為止，我們尚未在糖尿病族群中服用 EYP-1901。

And so obviously, we're looking for some basic acknowledgments that in this population that has a VEGF-mediated disease that our inserts work and are safe.

顯然，我們正在尋找一些基本的認識，以證明我們的插入物在患有 VEGF 介導疾病的人群中有效且安全。

And I can just remind everybody that we did release interim safety data as of last November in the PAVIA trial, and we had no VERONA EYP-1901 related ocular systemic complications.

我可以提醒大家，截至去年 11 月，我們確實在 PAVIA 試驗中發布了中期安全數據，並且我們沒有出現 VERONA EYP-1901 相關的眼部系統併發症。

So the read-through primarily will be, can we show a benefit in this particular disease.

因此，通讀的主要內容是，我們能否展示對這種特定疾病的益處。

DME is an extension of NPDR, just like PDR is an extension, as eyes get more ischemic and presumably VEGF levels and other cytokine levels go up higher, that's when you start to see this type of leakage in new blood vessels.

DME 是NPDR 的延伸，就像PDR 是NPDR 的延伸一樣，當眼睛變得更加缺血時，VEGF 水平和其他細胞因子水平可能會升高，這時您就會開始在新血管中看到這種類型的滲漏。

And therefore, I think if we can show in the NPDR population that we are making a biological improvement, I think they'll be definitely read through the DME.

因此，我認為如果我們能夠在 NPDR 人群中表明我們正在進行生物學改進，我認為他們肯定會透過 DME 來解讀。

As to the differences in the studies in the insert payloads, shouldn't matter.

至於插入有效負載研究的差異，則應該不重要。

Insert payloads, again, they release almost identically.

再次插入有效負載，它們的釋放幾乎相同。

They give levels that are consistent with the payload as opposed to the difference in the actual inserts.

它們給出的等級與有效負載一致，而不是實際插入的差異。

So I don't think those particular aspects of the differences between the VERONA trial, the PAVIA trial will be of any significance at all.

因此，我認為 VERONA 試驗和 PAVIA 試驗之間差異的那些特定方面根本沒有任何意義。

Graig Suvannavejh, Mizuho Securities.

Graig Suvannavejh，瑞穗證券。

Good morning.

早安.

Thank you for taking my question.

謝謝你回答我的問題。

I was curious in light of the data that you presented in wet AMD in the time since, have you been able to do any perhaps new market research with either clinicians or payers on their reactions?

我很好奇，鑑於您在濕性 AMD 方面提供的數據，您是否能夠針對臨床醫生或付款人的反應進行任何可能是新的市場研究？

And if you have, what were the findings?

如果有的話，結果是什麼？

And if you haven't done any, maybe you could just provide us a general big picture comment around what the feedback from the retinal specialist community has been.

如果您還沒有做任何事情，也許您可以向我們提供有關視網膜專家社群的回饋的一般性整體評論。

Thank you.

謝謝。

Thanks, Graig.

謝謝，格雷格。

That's a great question.

這是一個很好的問題。

And while I would say the formal aspects of both market research for both payers and practitioners is ongoing.

雖然我想說，針對付款人和從業者的市場研究的正式方面正在進行中。

And since it is ongoing, I really can't comment on how the new data has changed in a quantitative formal way, what the practitioners and the payers are thinking about EYP-1901.

由於它正在進行中，我真的無法評論新數據如何以定量形式的方式發生變化，從業者和付款人對 EYP-1901 的看法。

I can say, again, in a rather qualitative way, the initial interactions we have with the payers are quite positive.

我可以再次以相當定性的方式說，我們與付款人的最初互動是非常積極的。

And the practitioner is the same.

而修行者也是一樣。

Again, the data from DAVIO 2 was excellent.

DAVIO 2 的數據再次非常出色。

We had essentially no change in visual acuity over the six months after our inserts went in compared to the idea of control, and we did it with a really intact safety record and anatomic data that really went along with the visual acuity data.

與控制的想法相比，在插入後的六個月內，我們的視力基本上沒有變化，我們使用了真正完整的安全記錄和與視力數據真正相符的解剖數據。

So as the retina community is exposed to not only the initial data set, but the subsequent subset analysis.

因此，視網膜社群不僅接觸到初始資料集，也接觸到後續的子集分析。

I think the enthusiasm amongst the potential for this is definitely growing.

我認為人們對此的熱情肯定在增長。

And in a recent conference, I think when pulled of the new agents that are available, their pulled retina specialists put EYP-1901 as the most exciting.

在最近的一次會議上，我認為當拉出可用的新藥物時，他們的拉視網膜專家認為 EYP-1901 是最令人興奮的。

So I think our message in our great data is getting out there, and I think it will continue to be well received in both those communities.

因此，我認為我們透過大量數據傳達的訊息正在傳播出去，我認為它將繼續受到這兩個社區的好評。

Colleen Kusy, Baird.

科琳·庫西，貝爾德。

Great.

偉大的。

Good morning.

早安.

Thanks for taking our questions.

感謝您回答我們的問題。

On the wet AMD Phase 3 design, maybe this is something that you'll get more feedback on in your FDA meeting, but can you talk about your understanding of the role of the low-dose arm in the pivotal study design?

關於濕 AMD 3 期設計，也許您會在 FDA 會議上得到更多回饋，但您能談談您對低劑量組在關鍵研究設計中的作用的理解嗎？

Do you need to be better than the low dose?

您需要比低劑量更好嗎？

Or is that just for masking purposes?

或者這只是為了掩蓋目的？

And if you do have to be better, is that statistically significantly better or just a favorable trend?

如果你確實必須做得更好，那麼從統計數據來看，這是明顯更好還是只是一個有利的趨勢？

Thanks, Colleen.

謝謝，科琳。

So in our interactions with the FDA, the second arm of our drug was viewed as a way to improve the masking in the study.

因此，在我們與 FDA 的互動中，我們藥物的第二組被視為改善研究中掩蔽的一種方法。

There was never any indication or suggestion that the lower dose had to perform necessarily any different than the higher dose.

從來沒有任何跡像或建議表明較低劑量的表現必然與較高劑量有任何不同。

However, as we've talked about, the second reason we want to use two doses is that there was no dose response in DAVIO 2. 2 milligrams and 3 milligrams worked essentially equivalently.

然而，正如我們所討論的，我們想要使用兩種劑量的第二個原因是 DAVIO 2 中沒有劑量反應。

And therefore, we want the opportunity to test the dose that's around 2 milligrams in another dose that's possibly lower, that would dose be delivered by a single insert.

因此，我們希望有機會在另一個可能更低的劑量中測試大約 2 毫克的劑量，即透過單一插入物輸送的劑量。

And we hope to and expect to power the trial enough that the lower dose could show noninferiority against the aflibercept control group.

我們希望並期望為試驗提供足夠的動力，使較低劑量能夠顯示出相對於阿柏西普對照組的非劣效性。

Yale Jen, Laidlaw & Company.

耶魯‧詹 (Yale Jen)，萊德勞公司。

Good morning.

早安.

Thanks for taking the questions.

感謝您提出問題。

Just for the DME, I know it's probably a little bit later to happen.

就 DME 而言，我知道這可能會晚一點發生。

And in terms of 1901, what its real complaint?

就1901而言，它真正的抱怨是什麼？

Any differently in terms of the potential paradigm differences between the DME and with the wet AMD?

DME 和濕 AMD 之間的潛在範式差異有什麼不同嗎？

Thanks, Yale.

謝謝，耶魯。

That's a really good question, and it speaks to the differentiation in the 2 diseases of how they respond to anti-VEGFs.

這是一個非常好的問題，它說明了這兩種疾病對抗 VEGF 藥物反應的差異。

DME patients do respond to anti-VEGFs.

DME 患者確實對抗 VEGF 藥物有反應。

But the anatomic response is often delayed and takes multiple injections to actually see that response.

但解剖反應通常會延遲，並且需要多次注射才能真正看到反應。

Therefore, a sustained release inserts like EYP-1901 might not show a response faster than an anti-VEGF.

因此，像 EYP-1901 這樣的緩釋插入物可能不會比抗 VEGF 藥物表現出更快的反應。

But we would expect and hope that if the population of diabetics respond the same way that the wet AMD population responds, that we can show a similar benefit to other anti-VEGF agents with a significantly reduced treatment burden, that would be the goal.

但我們期望並希望，如果糖尿病患者群體的反應與濕性 AMD 族群的反應相同，那麼我們可以顯示出與其他抗 VEGF 藥物類似的益處，同時顯著減輕治療負擔，這將是我們的目標。

Yi Chen, H.C. Wainwright.

陳毅, H.C.溫賴特。

Thank you for taking my question.

謝謝你回答我的問題。

Can you provide us with your view on gene therapy being developed for wet AMD?

您能否向我們提供您對正在開發的濕性 AMD 基因療法的看法？

Whether they could be a big competitor for six months and nine months sustained therapy for wet AMD and whether their application could be limited to most severe patients?

它們是否可以成為濕性 AMD 六個月和九個月持續治療的主要競爭對手？

Thank you.

謝謝。

Thanks, Yi.

謝謝，易。

So gene therapy is certainly an exciting advance in the retina field.

因此，基因療法無疑是視網膜領域令人興奮的進步。

And as a replacement for a faulty gene, it's obviously been approved in that indication and really has been an incredible benefit to patients.

作為缺陷基因的替代品，它顯然已在該適應症中獲得批准，並且確實為患者帶來了令人難以置信的好處。

Using it as a drug delivery also shows promise, especially for chronic diseases.

將其用作藥物輸送也顯示出前景，特別是對於慢性疾病。

The issues around wet AMD really has to do with, first of all, the -- what appears to be a relatively narrow therapeutic window between efficacy and safety, that the gene therapies need to really thread.

圍繞濕性 AMD 的問題確實與，首先，基因療法需要真正解決療效和安全性之間相對狹窄的治療窗口有關。

And secondly, the question about alternatives.

其次，關於替代方案的問題。

Gene therapy is presumably going to be more expensive than current therapies or other therapies in development.

基因療法可能會比目前的療法或正在開發的其​​他療法更昂貴。

And therefore, how this one either an individual retina specialist or payers or society in general, justify the use of a more expensive-type treatment, if it's not clearly superior to what's out there already.

因此，如果這種治療方法沒有明顯優於現有的治療方法，那麼無論是個人視網膜專家還是付款人或整個社會，如何證明使用更昂貴的治療方法是合理的。

So at a high level, I think all retina specialists are excited about the promise of gene therapy.

因此，從高水準來看，我認為所有視網膜專家都對基因治療的前景感到興奮。

But in wet AMD particular, there's a really tight needle that needs to be threaded.

但特別是在濕 AMD 中，需要穿一根非常緊的針。

Thank you.

謝謝。

And I'm showing no further questions at this time.

目前我不會再提出任何問題。

Ladies and gentlemen, thank you for participating in today's conference.

女士們、先生們，感謝你們參加今天的會議。

This does conclude your program.

這確實結束了您的程式。

You may now disconnect.

您現在可以斷開連線。

Everyone, have a great day.

大家，祝你有美好的一天。

Thank you, everyone.

謝謝大家。