Aldeyra Therapeutics Inc to Discuss Regulatory Update on Reproxalap in Dry Eye Disease Call Transcript

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

Question: Tom Shrader - BTIG LLC - Analyst : Good afternoon. Thanks for taking my question. I think this question was asked, but I don't know that you answered it. Are you sure you don't have the same baseline mismatch in the trial you're about to submit? And just to be sure, the last time you kind of did quick and dirty as soon as you had a trial you resubmitted. At this time, are you pretty sure you will wait for both to be completed and then resubmit both? Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 03, 2025 / 9:00PM, ALDX.OQ - Aldeyra Therapeutics Inc to Discuss Regulatory Update on Reproxalap in Dry Eye Disease Call

Question: Tom Shrader - BTIG LLC - Analyst : And then do you think you'll resubmit the -- are you going to wait for both trials?

Question: Tom Shrader - BTIG LLC - Analyst : Okay. Great. Thanks a lot. Good luck.

Question: Catherine Novack - JonesTrading Institutional Services, LLC - Analyst : Hey, afternoon, Todd. Thanks for taking my question. Okay. I just wanted to ask what have you heard, if anything, from AbbVie and confirm that the option agreement ongoing. Deadline remains 10 days after approval, if any? And then how do you plan to proceed with them as you move forward with the FDA?

Question: Catherine Novack - JonesTrading Institutional Services, LLC - Analyst : Got it. And then you mentioned methodological issues. Were there any other identified besides the imbalance in baseline characteristics? And is there anything that you can discuss at the Type A meeting that might help you tweak or in some way improves change the ongoing trials to ensure that any of these issues are addressed.

Question: Catherine Novack - JonesTrading Institutional Services, LLC - Analyst : Got it. Thanks, Todd.

Question: Yale Jen - Laidlaw & Co - Analyst : Thanks for taking the questions. And this is -- for the field trials, two questions here. Number one, what stage they are right now? And would you anticipate actually finish that? And the second question is that I remember for the field trials, sometimes it'll be tough during -- at a time, if there's a spring or summer time where the hay fever and other stuff, how the situation occurs. So has the current ongoing study been through that or has been avoided? And thanks.

Question: Yale Jen - Laidlaw & Co - Analyst : Okay. Maybe just one more question here, which is based on the readout or the difference between placebo and the treatment of the chamber study, you have submitted with the CRL. But at least in terms of the delta, would that be sufficient for approval? In other words, does FDA have any questions regarding the delta between the treatment and placebo? And thanks.

Question: Yale Jen - Laidlaw & Co - Analyst : Okay. Great. The best of luck for you guys, and look forward to hear more.

Question: Mathew Caufield - H.C. Wainwright - Analyst : Hi, thanks, Todd. Based on the prior agency dialogue, do you have any indication the additional requested trial could be above and beyond the current two ongoing trials that the agency had already known about. Thanks, again.

Question: Mathew Caufield - H.C. Wainwright - Analyst : Understood. I appreciate that. Do you feel there's any preference to the field trial considering it might be more familiar from a labelling standpoint that you mentioned?

Question: Mathew Caufield - H.C. Wainwright - Analyst : Understood. Thanks a lot.

Question: Francois Brisebois - Oppenheimer - Analyst : Hi, thanks for the quick one here. I was just wondering, you said the trials that are ongoing, enrollment is complete. So there's no way just to take care of this baseline thing to increase the [N] number on these trials that maybe the stratification would be an angle, but you wouldn't increase the N number to take care of this. Is that fair?

Question: Francois Brisebois - Oppenheimer - Analyst : And have you disclosed what the difference is with between -- at baseline in the prior trials? Like I think you mentioned 7 here, normal would be 2, 3 or 4. Did you disclose what it was in the prior trials?

Question: Francois Brisebois - Oppenheimer - Analyst : Okay. Thank you.