Aldeyra Therapeutics Inc to Announce Topline Results from Phase 3 Dry Eye Disease Clinical Trials of Reproxalap Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Catherine Novack - JonesTrading Institutional Services, LLC - Analyst : Hi, morning, Todd. Always a pleasure to be on here talking about dry eye disease Phase 3 studies. I'm wondering if you can give us a sense of why you think the field trial did not hit stat [sig]. Was there unusually high vehicle efficacy, changes in methodology, or power and assumption versus prior field trials? Anything you can give would be helpful.

Question: Catherine Novack - JonesTrading Institutional Services, LLC - Analyst : Got it. And then if you can just maybe talk about how you think FDA will view the totality of the data, specifically any language in the CRL pertaining to the signs of dry eye, since tranquility one failed, but we had subsequent positive studies on redness, you know help us understand if they have any issue with having, one failing. And two positive studies to maybe see how they'll view the field versus the chamber trial.

Question: Catherine Novack - JonesTrading Institutional Services, LLC - Analyst : Got it. Thanks for clarifying Todd and thanks for taking my questions.

Question: Tom Shrader - BTIG LLC - Analyst : Good morning and congratulations. This newest trial, is the overall treatment effect about the same as the prior trial? I think it's considerably bigger. Is that right? And how do you explain that? And then one sort of nagging question. There's always a comment or somewhere in your presentation about irritation with the drops. We've been hearing a little bit about that. How bad is it? Do you think it's a commercial issue, and do you ever have a patient that won't take the second drop, which I suppose is the most relevant question? Thanks.

Question: Tom Shrader - BTIG LLC - Analyst : Okay, great. Thanks for the color type.

Question: Mathew Caufield - H.C. Wainwright - Analyst : Hi Todd, good morning. I'm excited to see the advancements this morning. I wanted to ask about the top considerations for timing and potential execution from AbbVie for the for the option agreement. And then separately as we think about the dry eye landscape, what criteria could select patients as the best fit for receiving Reproxalap versus trying any alternatives, in terms of kind of what that selection process could look like. Thanks again.

Question: Mathew Caufield - H.C. Wainwright - Analyst : Excellent, very helpful. I really appreciate that.

Question: Yale Jen - Laidlaw & Company Ltd. - Analyst : Good morning, thought and congrats on the outcome. Just two questions here. The first one is for the field trial that shows week one to six. I'm just curious what that average the measurements over average of each week or just to the end of the study period, and I have a follow up.

Question: Yale Jen - Laidlaw & Company Ltd. - Analyst : Okay, great. That's very helpful in the details. And then maybe one more question here, which is that the it's sort of clear that Reproxalap has a very acute effect. And but also you mentioned about the chronic effect value. So, would you elaborate a little bit more on that, given that most of the drugs it's only on the chronic one, but not necessarily acute treatment effects and effects. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 06, 2025 / 12:00PM, ALDX.OQ - Aldeyra Therapeutics Inc to Announce Topline Results from Phase 3 Dry Eye Disease Clinical Trials of Reproxalap Call

Question: Yale Jen - Laidlaw & Company Ltd. - Analyst : Okay, great. This is a very helpful and again congrats on the data and the best luck for the application.

Question: Kelly Shi - Jefferies LLC - Analyst : Hey, good morning, Todd. This is Joseph for Kelly. Thanks for taking my question. It's part of a clarification question. When FDA raised concerns about baseline differences between the placebo and treatment arms, were they referring to the first measurement post-chamber entry, either screening or treatment specifically, or was the differences in base baseline prior to any chamber entry? And also on the Type A meeting, I believe you mentioned you had already been scheduled for 30 days last month. Is it fair to assume it's happening soon, or did it get pushed back? Any call you can provide in that phone will be helpful.

Question: Yale Jen - Laidlaw & Company Ltd. - Analyst : Very helpful. Thank you.