Ocular Therapeutix Inc (OCUL) 2024 Q3 法說會逐字稿

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（技術難度）

Variability, enhancing patient selection. And we believe strengthening the potential for successful clinical trial outcomes from the onset. We also designed so one and solar to complement each other and boost recruitment for both studies.

可變性，增強患者的選擇。我們相信從一開始就增強臨床試驗成功的可能性。我們也設計了這樣一個系統和太陽能係統來相互補充，並促進兩項研究的招募。

Initially, all subjects enrolling in solar were required to be loading or randomization failures. And so one, this approach ensured that solar which is widely seen as the more attractive trial for physicians to enrol their patients in did not cannibalize enrolment in soul one.

最初，所有參與太陽能研究的受試者都必須是負荷或隨機化失敗的。因此，這種方法確保了太陽能試驗不會蠶食靈魂一號試驗的招募，太陽能試驗被廣泛視為醫生招募患者的更具吸引力的試驗。

As I shared at the outset of my comments today, we're announcing that so one has reached a key enrolment milestone and our trial sites are now enrolling subjects directly into solar.

正如我今天在評論開始時所說的那樣，我們宣布我們已經達到了一個關鍵的招募里程碑，我們的試驗點現在正在直接招募太陽能研究對象。

We expect this important update will lead to further acceleration in solar enrolment which is already well underway as soul one very quickly approaches complete randomization subjects who are not ultimately randomized and seamlessly transition into solar.

我們預計這項重要更新將進一步加速太陽能登記的工作，這項工作已經在順利進行中，因為靈魂一號很快就會接近完全隨機化的受試者，而這些受試者最終不會被隨機化並無縫過渡到太陽能。

This coordinated approach allowed us to avoid the typical slowdown seen toward the end of trial enrolment, creating a streamlined and efficient pathway that capitalizes on recruitment momentum at our clinical sites.

這種協調的方法使我們能夠避免在試驗招募結束時出現的典型放緩現象，從而創建一條精簡而高效的途徑，充分利用我們臨床站點的招募勢頭。

We believe that this will provide us with a tremendous advantage as we continue to strengthen our deep history and strong relationships with our clinical trial sites. Heading into 2025.

我們相信，這將為我們提供巨大的優勢，因為我們將繼續加強與臨床試驗地點的深厚歷史和牢固關係。邁向 2025 年。

The bottom line is that we've seen outstanding demand for participation in our expat clinical studies underscoring the strong enthusiasm and interest within the retina community for a durable treatment option.

最重要的是，我們看到了對我們外籍人士臨床研究的積極參與，凸顯了視網膜界對持久治療方案的強烈熱情和興趣。

This level of demand is particularly encouraging as it signals the excitement for expat among both patients and physicians based on our historical clinical data generated for expats combined with actions we have taken to derisk our soul studies.

這種需求水平尤其令人鼓舞，因為它表明患者和醫生都對外籍人士感到興奮，這是基於我們為外籍人士生成的歷史臨床數據，結合我們為降低靈魂研究風險而採取的行動。

We remain confident in the potential success of both soul one and solar to date. [AAX] is the only TKI we are aware of to show proof of concept for monotherapy activity in treatment. Naive wet AMD patients to take that a step further. If you look at our prior us wet AMD study treatment with a [paxi] alone resulted in an impressive 100% per protocol rescue free rate at six months.

迄今為止，我們仍然對 Soul One 和 Solar 的潛在成功充滿信心。 [AAX] 是我們所知的唯一一種能夠證明單一療法療效的 TKI。初治濕性 AMD 患者可以更進一步。如果您看一下我們先前對美國濕性 AMD 的研究，單獨使用 [paxi] 治療在六個月內取得了令人印象深刻的 100% 的按方案免費救援率。

And that wasn't a trial where no steps were taken to de risk the patient population or trial design.

這並不是沒有採取任何措施降低病患群體或試驗設計風險的試驗。

Finally, we believe X [paxi] is the only TKI to show clear signals of efficacy in subjects with Non proliferative diabetic retinopathy or NPDR. In our Helios trial, the administration of a single [X paxi] hydrogel, literally zero subjects were observed to have developed any vision threatening complications at 48 weeks compared to 38% of subjects in the Sham Control arm which is in line with natural history data.

最後，我們相信 X [paxi] 是唯一對非增生性糖尿病視網膜病變或 NPDR 患者顯示出明確療效的 TKI。在我們的 Helios 試驗中，使用單一 [X paxi] 水凝膠後，在 48 週時幾乎沒有觀察到任何受試者出現任何威脅視力的併發症，而假手術對照組中出現該併發症的受試者為 38%，這與自然史數據一致。

In other words, not a single patient after just one injection of AAX developed a potentially blinding complication at 48 weeks.

換句話說，僅注射一次 AAX 後，沒有一位患者在 48 週內出現潛在的致盲併發症。

Moreover, every subject in the [AAX] arm with Non centre involved diabetic macular edema experienced disease improvement, it cannot be overstated.

此外，[AAX] 組中每位患有非中心糖尿病性黃斑水腫的受試者的病情都得到了改善，這一點怎麼強調也不為過。

These types of results do not occur by accident.

這些類型的結果並非偶然發生的。

We believe the results from soul one and so are may set a new standard emphasizing the strength of our data and underscoring our advantages in the competitive landscape as such is it is imperative that we be prepared for a strong commercial launch should be approved if clinical demand is a proxy for commercial interest and we believe it is then we should plan for strong commercial interest in expat potentially ushering in a new era of wet AMD treatment.

我們相信，Soul One 等公司的結果可能會樹立一個新的標準，強調我們數據的優勢並強調我們在競爭環境中的優勢，因此，我們必須為強大的商業發布做好準備，如果臨床需求是商業利益的代表，那麼我們相信，我們應該為外籍人士的強烈商業興趣做好計劃，這可能開創濕性 AMD 治療的新時代。

We benefit greatly from having a remarkable commercial team that is currently achieving excellent results with Dexten Za the first and only drug alluding intracanalicular insert extensa utilizes the same technology that is used in ex [paxi] and its performance strengthens our market presence and provides a strategic edge that we're committed to maintaining.

我們受益匪淺，因為我們擁有一支出色的商業團隊，該團隊目前正在通過 Dexten Za 取得優異成績，Dexten Za 是第一個也是唯一一個暗示小管內插入物的藥物，它採用了與 ex [paxi] 相同的技術，其性能增強了我們的市場地位並提供了我們致力於保持的戰略優勢。

We have taken several steps over the past few months to build on our existing commercial infrastructure to support the eventual manufacture and distribution of AAX to retina specialists.

過去幾個月，我們已採取多項措施，在現有商業基礎設施的基礎上，支援最終製造和向視網膜專家分發 AAX。

And we plan to further expand these efforts in 2025 as we continue to execute our commitment to the investment community is to maintain financial discipline based on our current operating plans. We believe our cash and cash equivalents of approximately $427 million on hand at the end of the third quarter, provides runway into 2028 and fully funds stole one and so are the top line results.

我們計劃在 2025 年進一步擴大這些努力，同時我們將繼續履行對投資界的承諾，即根據我們目前的營運計劃保持財務紀律。我們相信，截至第三季末，我們手頭上的現金和現金等價物約為 4.27 億美元，為 2028 年提供了充足的資金，營收業績也是如此。

As we conclude the prepared remarks in today's call, I'd like to leave you with these key messages.

在我們結束今天的電話會議的準備好的演講時，我想給你們留下這些關鍵訊息。

Our mission at ocular is clear.

我們在 Ocular 的使命非常明確。

We are dedicated to becoming a leader in the treatment of retinal disease and improving vision in the real world.

我們致力於成為治療視網膜疾病和改善現實世界視力的領導者。

We are making outstanding progress on the two complementary studies in our registrational program for [exaxe and wetam MD].

我們在註冊計劃的兩項互補研究中取得了突出進展[exaxe 和 wetam MD]。

So one and solar so one has reached a key enrolment milestone, and we expect to complete. So one randomization by your end with topline data to follow in the fourth quarter of 2025 solar enrolment continues to gain momentum and physicians can now enrol their patients directly into this clinical trial in type C written responses received this year.

So one 和 solar so one 已經達到了一個關鍵的招生里程碑，我們期待完成。因此，您最終將進行一次隨機化，並在 2025 年第四季度追蹤頂線數據，太陽能登記繼續獲得發展勢頭，醫生現在可以根據今年收到的 C 型書面回覆將他們的患者直接登記到這項臨床試驗中。

The FDA has agreed that the design of these two studies should be sufficient to meet our regulatory requirements. And we believe positive data from these studies will enable us to achieve a differentiated product label, provide commercial, commercially relevant data and meet the real world need for a sustainable treatment option that improves long term outcomes for patients with wet AMD 2024 has been a year of significant change and tremendous execution at ocular.

FDA 已同意這兩項研究的設計應該足以滿足我們的監管要求。我們相信，這些研究的積極數據將使我們能夠獲得差異化的產品標籤，提供商業化的、商業相關的數據，並滿足現實世界對可持續治療選擇的需求，從而改善濕性 AMD 患者的長期治療結果。

But this is all in anticipation of what's ahead as we prepare for what we expect will be a milestone year in 2025.

但這一切都是為未來所做的預期，因為我們正在為預計的里程碑之年 2025 年做準備。

We thank you for your ongoing encouragement and support for ocular therapeutics operator.

感謝您一直以來對眼科治療操作員的鼓勵與支持。

I would now like to open the call for questions.

現在我想開始提問。

At this time. We'll be conducting a question-and-answer session. (Operator instructions).

此時。我們將進行問答環節。（操作員指令）。

Our first question comes from Tazeen Ahmad with Bank of America. Please proceed with your question.

我們的第一個問題來自美國銀行的 Tazeen Ahmad。請繼續回答您的問題。

Hi guys. Good morning. Thanks for taking my question and congratulations on the continued momentum with the studies. Maybe a couple of points of clarification [Praveen]. Can you talk to us about how many of the sites for? So one and so are, are currently overlapping and are you still planning on activating additional sites for so large? You know, the pace of enrolment has continued to be above expectations. Just curious if you still think you need additional sites to get to the finish line. Thanks.

嗨，大家好。早安.感謝您回答我的問題，並祝賀研究繼續取得進展。也許需要澄清幾點[普拉文]。您能告訴我們有多少個站點嗎？那麼，目前是重疊的，您仍計劃啟動如此大規模的其他網站嗎？您知道，入學速度一直超乎預期。只是好奇您是否仍然認為需要額外的站點才能到達終點線。謝謝。

Thank you for your question. And, and, and good morning. The answer is yes, there are quite a few sites that are overlapping and that is by design. As you know, these two studies are designed very thoughtfully to complement each other in terms of their recruitment. One of the really outstanding features here is that there is no slowdown.

感謝您的提問。還有，還有，早安。答案是肯定的，有相當多的站點是重疊的，這是設計使然。如您所知，這兩項研究的設計非常周到，在招募方面可以相互補充。這裡真正突出的特點之一是沒有減速。

Typically, what happens at about this time is the sponsor says, look, we are enrolling and please slow down. We we're completing enrolment and please slow down the sites. Think of that as we got to stop now and perhaps think of another trial that's not happening with us at all. We are full speed ahead. We don't slow down whatsoever and there's a seamless transition between soul one and solar.

通常，在這個時候，贊助商會說，看，我們正在招生，請放慢速度。我們正在完成註冊，請降低網站速度。想想我們現在必須停下來，也許想想另一場根本不會發生在我們身上的審判。我們正全速前進。我們不會放慢任何速度，靈魂一和太陽之間有著無縫的過渡。

So yes, there are overlapping sites, and this is absolutely by design. So there's a seamless transition and yes, we are continuing to activate other sites. Solar is a larger study, and we will continue to go ahead and press forward with that and execute as quickly as we possibly can. Thank you.

所以是的，存在重疊的站點，這絕對是設計使然。因此這是一個無縫過渡，是的，我們會繼續激活其他網站。太陽能是一項更大的研究，我們將繼續推進這項工作並儘快執行。謝謝。

Biren Amin, Piper Sandler.

比倫阿明、派珀桑德勒。

Yeah. Hi guys. Thanks for taking my question and congrats on all the progress Pravin, you mentioned that you expect to have a differentiated product label with exactly.

是的。嗨，大家好。感謝您回答我的問題，並祝賀 Pravin 取得的所有進步，您提到您希望擁有一個完全差異化的產品標籤。

Could you maybe define that for us? Is that based on treatment frequency or are you focused on other metrics? Thank you.

您能為我們定義一下嗎？這是基於治療頻率還是您關注其他指標？謝謝。

Biren and good morning. And thank you for your question. It's a very important question. And look again, I go back to the design of so one and solar.

Biren，早安。感謝您的提問。這是一個非常重要的問題。再看一下，我回到瞭如此一個太陽能的設計。

And what I would say is that as a clinician, I can tell you it answers all the questions that clinicians have, which is, you know, is how relevant is this clinically in terms of the way I would treat a patient?

我想說的是，身為臨床醫生，我可以告訴你，它回答了臨床醫生的所有問題，也就是說，就我治療病人的方式而言，這與臨床有多大關係？

It certainly answers the question of durability, which is from Seoul one. It answers the question of repeatability, which is so large. It answers, your questions in regard to how it compares to the fibro 2 mg as well as the high dose. [IIA].

它確實回答了耐用性的問題，這是來自首爾的問題。它回答了可重複性這個非常大的問題。它回答了您關於它與 2 毫克纖維以及高劑量相比的問題。[IIA]。

So our expectation is that if we are fortunate enough to have this drug approved, that we will have a strategic program in terms of a label that may include flexibility from six months to nine months with soul one and solar repeatability based on solar as well as pop potentially the only label that will have a superiority. So we believe that we'll have both a regulatory advantage as well as a commercial advantage potentially if this drug should be approved.

因此，我們的期望是，如果我們夠幸運，這種藥物能夠獲得批准，那麼我們將在標籤方面有一個戰略計劃，其中可能包括從六個月到九個月的靈活性，其中的靈魂一號和基於太陽能的太陽能重複性以及流行可能成為唯一具有優勢的標籤。因此，我們相信，如果該藥物獲得批准，我們將擁有監管優勢和商業優勢。

Tara Bancroft, TD Cowen.

塔拉·班克羅夫特（TD Cowen）。

Hi, good morning. So now that so our enrolment can accelerate as a standalone trial. Are you going to be providing regular updates on enrolment progress? And what are your general expectations for how long enrolment could take for solar now? Thanks.

嗨，早安。所以現在我們的招募可以作為獨立試驗加速進行。您會定期更新入學進度嗎？您對於目前太陽能專案的報名需要多長時間有什麼預期？謝謝。

Thank you and good morning to you. We will be providing updates as appropriate. What I would emphasize here is what I said in the beginning, which is how thoughtfully these two trials are designed. I realize that there is no slowdown here whatsoever. All the patients that are in Seoul one currently will seamlessly transition into solar.

謝謝你，早安。我們將適時提供更新資訊。我在這裡要強調的是我一開始就說過的，這兩項試驗的設計是多麼的周到。我意識到這裡根本沒有任何放緩的跡象。目前在首爾一號的所有患者都將無縫過渡到太陽能治療。

So solar which is already recruiting will have a really large bolus of patients coming in from soul one. And that is again, very thoughtfully and deliberately a design. So what I would also say is that from the very beginning, as you know, the challenge was really the enrolment of soul one which may be less of a familiar design than solar.

因此，正在招募患者的 Solar 將會從 Soul One 接收大量患者。這又是一個非常深思熟慮和謹慎的設計。所以我想說的是，從一開始，如你所知，挑戰實際上是靈魂的招募，這可能不像太陽那樣是一種熟悉的設計。

And I think most people have always said that solar may be the more familiar treatment that the more familiar clinical trial design as it is a noninferiority design. So we do believe that that transition from soul one to solar will be seamless. We're very encouraged in terms of the recruitment pace for solar and yes, we will provide updates when appropriate. Thank you.

我認為大多數人一直都說，太陽能可能是比更熟悉的臨床試驗設計更熟悉的治療方法，因為它是一種非劣效性設計。所以我們確實相信，從靈魂一號到太陽一號的轉變將是無縫的。我們對太陽能招募步伐感到非常鼓舞，是的，我們會在適當的時候提供更新。謝謝。

Kelly Shi, Jeffrey.

凱莉·施（Kelly Shi），傑弗裡（Jeffrey）。

And thank you for taking my questions. Just quickly, can you share with us the progress of the discussion with EMA? That's the first question. And secondly, as both. So what and so are show great physician patient engagement reflected by enrolment progress. Can you share what kind of patient population mostly suitable for [PY MD] based on trial enrolment experience? Thank you very much.

感謝您回答我的問題。您能否與我們分享一下與 EMA 討論的進展？這是第一個問題。其次，兩者皆是。那麼，從入學進度來看，醫師患者的參與度很高。根據試驗招募經驗，您能否分享哪一種病患族群最適合[PY MD]？非常感謝。

Kelly. Good morning to you. And thank you for your question. In regard to regulatory agencies outside the US, we certainly are engaged in discussions. We haven't guided you yet as to the formal basis of those discussions and we will, when appropriate, in terms of patient population, there are two different aspects to this. One is the patient population that we're enrolling for clinical trials.

凱利。早安.感謝您的提問。對於美國以外的監管機構，我們當然正在進行討論。我們尚未就這些討論的正式基礎向您提供指導，我們將在適當的時候，就患者群體而言，這有兩個不同的方面。一是我們招募的參加臨床試驗的患者群。

And the other one is what would be, would be relevant when this, if this is approved and is out in the market. So in terms of the clinical trial, as you've heard from my prepared remarks, I think we've gone out of our way to make sure that we derisk this patient population as much as possible in order to increase the chance of success. And we've done that in a very bespoke manner for each clinical trial. So one and solar as we discussed with.

另一個問題是，如果這項技術獲得批准並推出市場，那麼這將具有什麼意義？因此，就臨床試驗而言，正如您從我的準備好的發言中聽到的那樣，我認為我們已經竭盡全力確保盡可能降低該患者群體的風險，以增加成功的機會。而且，我們對每個臨床試驗都採取了非常客製化的方式。因此，正如我們所討論的，其中一個是太陽能。

So one as you know, as a superiority study, what we've done is to select patients that we believe would be most responsive to anti vegf treatment with. So solar, what we've done is to select patients that would be as stable as possible for a non-inferiority clinical trial.

因此，如您所知，作為一項優越性研究，我們所做的是選擇我們認為對抗 VEGF 治療最有反應的患者。因此，我們所做的是選擇盡可能穩定的患者進行非劣效性臨床試驗。

Again, a very de risk patient population, in regard to the market, we firmly believe that this drug if approved will be the drug of choice for all patients. Our job at this point is to get this drug approved. However, what will happen we believe in the market as has been shown historically, is a much wider use of this drug. Thank you for your question.

再次，對於市場而言，患者風險非常低，我們堅信，如果獲得批准，這種藥物將成為所有患者的首選藥物。我們現在的任務是讓這種藥物獲得批准。然而，我們相信市場將會發生這種情況，正如歷史所表明的那樣，這種藥物的使用將更加廣泛。感謝您的提問。

Thank you.

謝謝。

Our next question comes from Sean McCutcheon with Raymond James. Please proceed with your question. Hi, good morning. Thanks for taking the question. Can you elaborate a bit more on the commercial efforts you alluded to in your comments and obviously too early to talk about pricing specifics.

我們的下一個問題來自雷蒙德詹姆斯 (Raymond James) 的肖恩麥卡琴 (Sean McCutcheon)。請繼續回答您的問題。嗨，早安。感謝您回答這個問題。您能否進一步詳細說明您在評論中提到的商業努力？

But you know, we hear a lot and I'm sure you do as well on speculation on the buy and bill model for, you know, the currently marketed individual injectable therapeutics in the space and how that could influence prescribing patterns.

但是您知道，我們聽到了很多關於購買和付款模式的猜測，您知道，目前該領域銷售的個體注射療法以及這將如何影響處方模式。

So what are your high level thoughts on the, the pricing model for say a Q six month or longer product and how that plays into your strategy on how you can leverage those incentives at these high volume centres? Thanks.

那麼，您對 Q 六個月或更長時間產品的定價模型有何高層次的想法，以及該定價模型如何影響您在這些高容量中心利用這些激勵措施的策略？謝謝。

Yeah, good morning, Sean. And thank you for your question. It's a great question and obviously we're a little bit early in terms of talking about pricing. You know, what I will tell you is from a commercial point of view. Look, you know, I'm in a situation here where I'm very, very fortunate that we have a fantastic commercial team that has been very successful with Dextenza.

是的，早上好，肖恩。感謝您的提問。這是一個很好的問題，顯然我們現在談論定價還為時過早。你知道，我要告訴你的是從商業角度來講的。你知道，我現在的處境非常非常幸運，我們擁有一支出色的商業團隊，他們在 Dextenza 方面取得了巨大的成功。

And in order to leverage that talent into retina is, is really a privilege. Look, in terms of pricing, we, we firmly believe that we will be able to obtain premium pricing. I think it is a little bit early at this point to talk about the specifics of the strategy for, for pricing. We will certainly address that when appropriate. But thank you for the question.

而將這種才能運用到視網膜上，真是一種榮幸。從定價方面來看，我們堅信我們能夠獲得溢價。我認為現在談論定價策略的具體細節還為時過早。我們肯定會在適當的時候解決這個問題。但感謝您的提問。

Jonathan Wolleben with citizens, JMP.

喬納森·沃勒本 (Jonathan Wolleben) 與公民、JMP 在一起。

Hi, this is Catherine on for John. I have two quick ones for Dextenza. I'm just wondering if you guys are reiterating your guidance for 2024 and also any commentary on the CMS rule for 2025 and kind of how that's going to affect pricing of the extensa going forward.

你好，我是凱瑟琳，代表約翰。我對 Dextenza 有兩個簡短的看法。我只是想知道你們是否重申了對 2024 年的指導，以及對 2025 年 CMS 規則的任何評論，以及這將如何影響未來 Extensa 的定價。

Catherine again. Thank you again for your question and good morning. I'm very fortunate again, as I say to have a fantastic commercial team for Dextenza. And I'm fortunate also to have Steve Myers here with me who's our Chief Commercial Officer. And let me hand over to Steve to answer that question, Steve.

又是凱瑟琳。再次感謝您的提問，早安。正如我所說，我再次感到非常幸運，因為 Dextenza 擁有一支出色的商業團隊。我也非常榮幸能夠邀請到我們的首席商務官史蒂夫·邁爾斯 (Steve Myers) 來和我一起出席。現在讓我把這個問題交給史蒂夫來回答，史蒂夫。

Yeah, thanks for being. Yes, to extend those definitely remains on track to hit the guidance that we guided to previously. So we feel great there regarding the CMS rule. We are very pleased with the results of the rule. We continue to have separate payment in the ASC but the rule we confirm that we're going to return separate payment in the HOPD. So we feel great about the, the role that was issued and, and, and the facts it'll have in 2025. Thanks for the question.

是的，謝謝你的存在。是的，延長這些期限肯定仍能達到我們先前指導的預期。因此，我們對 CMS 規則感到非常滿意。我們對規則的結果非常滿意。我們繼續在 ASC 中進行單獨付款，但根據規則，我們確認將在 HOPD 中退還單獨付款。因此，我們對所發布的角色以及它在 2025 年將發揮的作用感到非常滿意。謝謝你的提問。

Thank you.

謝謝。

Yi Chen, HC Wainwright.

陳毅，HC溫賴特。

So, thank you for taking my questions. I have a question regarding the program in diabetic retinopathy. So, do you think, do you believe the next trial for ADR will be a phase two or phase three trial? And which FX end point do you think will be appropriate as a pivotal trial? Endpoint? Is it DRSS improvement or is it disease progression from Non proliferative stage to proliferative stage of DRSS? Thank you.

感謝您回答我的問題。我對糖尿病視網膜病變計劃有疑問。那麼，您是否認為 ADR 的下一個試驗將是第二階段還是第三階段試驗？您認為哪個 FX 終點適合作為關鍵試驗？終點？這是 DRSS 改善還是疾病從 DRSS 非增生期進展到增生期？謝謝。

Good morning and thank you for your question. It's a great question. What I will tell you is, look, there are two takeaways that we have from the Helio study. One is the line of sight to the success of the soul programs. There is no doubt whatsoever that this drug is present safe and effective at 48 weeks for the Helio study. The second takeaway is the opportunity that we have for diabetic retinopathy and for diabetic macular edema. I think what's, you know, probably forgotten a little bit is that every single patient who had diabetic macular edema in the Helio study and I mean, every single patient had improvement, and this was concentre involving diabetic macular edema. But even in this nonselected patient population, every single patient that had a concentre involving diabetic macular edema improved with the drug that that's a really important thing. What we've committed to doing is to going to the FDA and pursuing diabetic retinopathy as well as diabetic macular edema. We'll wait for the feedback from the FDA. We're very flexible in terms of what we need to do. We'll make a very thoughtful strategic choice as to the endpoints. Again, that is pending the discussion with the FDA. But what I want to emphasize here, which I think is as a clinician, I can tell you is absolutely remarkable is what we look for is the prevention of blindness in diabetic retinopathy. What we call vision threatening complications and that primarily is diabetic macular edema as well as proliferative diabetic retinopathy and with a single injection of AXA at week 48 vision threatening complications was literally zero in the control arm. It was over 30% which is what one would expect with the natural history studies.

早安，感謝您的提問。這是一個很好的問題。我要告訴你們的是，我們從 Helio 研究中得到了兩點啟示。一是視線看靈魂計畫是否成功。毫無疑問，在 Helio 研究中，該藥物在 48 週時是安全有效的。第二個要點是我們在治療糖​​尿病視網膜病變和糖尿病黃斑水腫方面所擁有的機會。我認為，您可能有點忘記了，Helio 研究中每一位患有糖尿病性黃斑水腫的患者，我的意思是，每一位患者都得到了改善，而且這主要涉及糖尿病性黃斑水腫。但即使在這個未經選擇的患者群體中，每一個患有糖尿病性黃斑水腫的患者在服用藥物後病情都得到了改善，這是非常重要的。我們致力於向 FDA 申請並研究糖尿病視網膜病變以及糖尿病黃斑水腫。我們將等待 FDA 的回饋。對於需要做的事情，我們的選擇非常靈活。我們將對終點做出非常深思熟慮的策略選擇。再次強調，這還有待與 FDA 的討論。但我想在這裡強調的是，作為一名臨床醫生，我可以告訴你，絕對值得注意的是，我們所尋求的是預防糖尿病視網膜病變導致的失明。我們所說的視力威脅性併發症主要是糖尿病性黃斑水腫以及增生性糖尿病視網膜病變，而在第 48 週注射一次 AXA 後，對照組的視力威脅性併發症實際上為零。它超過了 30%，這是自然歷史研究所預期的。

So to have the possibility of sitting with a patient and saying Mr. Smith, your chance of having vision threatening complications that are potentially blinding are over 30% year upon year. But with a single injection of AAX, if you come to see me once a year, as you would go to your dentist for teeth, cleaning your chance of maintaining vision and not going blind is literally zero. That's a pretty powerful argument. So we absolutely are very excited about diabetic retinopathy and diabetic macular edema. And we will pursue that pending our discussion with the FDA. The only reason and I want to emphasize that that that hasn't happened as yet is simply because our priority at this point is the sole programs. So one and solar and as solar gets underway, as you've heard, we will be pursuing a diabetic retinopathy and diabetic macular deal.

因此，當我們坐在病人面前對他說史密斯先生，您出現有視力威脅的併發症並可能導致失明的幾率每年都在 30% 以上。但是，只需注射一次 AAX，如果您每年來看我一次，就像您去看牙醫一樣，清潔您的牙齒，保持視力並且不失明的機會實際上為零。這是一個非常有力的論點。因此，我們對糖尿病視網膜病變和糖尿病黃斑水腫感到非常興奮。我們將與 FDA 進行討論並繼續推進這項工作。唯一的原因是，我想強調的是，這至今還沒有發生，只是因為我們目前的首要任務是唯一的專案。因此，正如您所聽到的，隨著太陽能的發展，我們將進行糖尿病視網膜病變和糖尿病黃斑部治療。

Thank you for your question.

感謝您的提問。

Thank you. Pravin.

謝謝。普拉文。

Greg Harrison, Scotia Bank.

加拿大豐業銀行的格雷格·哈里森。

Hey, good morning. Thanks for taking the question. Just thinking about the regulatory submission in web MD. Will you need to submit data from? So one and Solar [Soult] simultaneously or is there a potential for rolling submission once you have top line data from so one just trying to understand how much of a gaining factor so our enrolment will be.

嘿，早安。感謝您回答這個問題。只是考慮一下 Web MD 中的監管提交。您需要提交資料嗎？因此，一個人和 Solar [Soult] 同時提交，或者一旦您獲得了頂線數據，是否有可能進行滾動提交，一個人只是想了解我們的入學率會有多大的增長因素。

Greg Thank you for your question and good morning to you.

格雷格，謝謝您的提問，早安。

You know, look what I would say is, our regulatory path is about as clear as it can possibly be.

你知道，我想說的是，我們的監管路徑已經盡可能地清晰了。

As you know, we have a spa for so on for solar. We have a written type C meeting response. It clearly states that all we need are these two studies for approval we don't need anything else. Traditionally, the FDA has required two positive studies. We believe that that will still be the case where we are in a very close collaboration with the FDA. But at this point, our assumption is that we will need two positive studies as has been the case historically. Thank you for your question.

如您所知，我們有一個用於太陽能的水療中心。我們有一份書面的 C 類會議回覆。它明確指出，我們所需要的只是這兩項研究的批准，不需要任何其他東西。傳統上，FDA 要求進行兩項積極的研究。我們相信，我們與 FDA 的密切合作仍將持續下去。但目前，我們的假設是，我們將需要兩項積極的研究，就像歷史上的情況一樣。感謝您的提問。

Thanks.

謝謝。

This includes our question-and-answer session. I will now turn the call back over to Dr Praveen Dugal for closing remarks.

這包括我們的問答環節。現在我將把電話轉回給 Praveen Dugal 博士，請他作最後發言。

Thank you. Once again, I'd like to thank everyone for taking the time to join our call today.

謝謝。我再次感謝大家今天抽出時間參加我們的電話會議。

We look forward to updating you on our progress and if you have any follow up questions, please reach out to Bill Slattery, our Vice President of Investor Relations. Thank you again for joining our call. Have a great day. Everyone.

我們期待向您通報我們的進展，如果您有任何後續問題，請聯絡我們的投資者關係副總裁 Bill Slattery。再次感謝您加入我們的電話會議。祝你有美好的一天。每個人。

This includes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

其中包括今天的電話會議。現在您可以斷開您的線路。感謝您的參與。

Portion of this transcript marked (technical difficulty) indicate an audio problem. The missing text will be supplied if a replay becomes available.

本記錄中標示「技術難題」的部分錶示有音訊問題。如果有重播的話，將會補充缺少的文字。