Ocular Therapeutix, Inc. (NASDAQ:OCUL) Q2 2023 Earnings Call Transcript

But I think we’d like to stay pure to the redosing based upon the qualities of the drug. We’re not going to disclose the redosing of the pivotal trial today.

Colleen Kusy: Understood. Thanks for taking our questions.

Antony Mattessich: Thanks, Colleen.

Operator: Thank you. Please hold for our next question. Our next question comes from Kelly Shi of Jefferies.

Kelly Shi: Thank you for taking my questions. I’m curious whether the second trial of wet AMD has the same trial design as the first one? And, have you discussed with FDA on this front? And, secondly, regarding the patient enrollment criteria, patient baseline characteristics, is it more similar to the US Phase 1 trial? Thank you.

Rabia Ozden: The — our second pivotal trial would be the same design as this first pivotal trial, the — that’s our intention now. And, at this point, for the FDA discussions, as I mentioned, we had several meeting afterwards, communications, with the FDA for the current design, we are going to initiate soon. That’s why our discussions with FDA just provided us that they found this design is a reasonable pivotal design. And the — your last question around eligibility, whether it would be, like, similar to our US Phase 1 trial. Again, we would like to disclose design details and highlights of the eligibility, and all those details, after we initiate the trial, first trial.

Kelly Shi: Thanks. Looking forward to more details.

Rabia Ozden: Thank you, Kelly.

Antony Mattessich: Thank you, Kelly.

Operator: Thank you. Please hold for next question. Our next question comes from Tara Bancroft of TD Cowen.

Tara Bancroft: Hi, good afternoon. So I was hoping, can you say what time point the primary endpoint is. And if this is going to be run in treatment naive patients, how many injections do these patients typically get in that amount of time that the primary endpoint is being measured. And I’m asking because I’m trying to get an idea, like, Dane and Joe said, how you’ll convince patients to enroll in the trial and how you’ll control for dropouts when patients progress?

Rabia Ozden: Yes. Again, Tara, thank you for the question. Some of the things I may not be answer because of the design, but I can say that when we discussed the design, again, this is a durability design and durability design for TKI versus a single injection. Again, loading doses or not, you will see that when we get there. But this design to our understanding with extensive discussions with the clinical trialists is an acceptable to design to them and also their patients. That being said, the dropouts, and et cetera with the criteria we have, our retreatment criteria, when you see those and when you see the eligible criteria, you would see why this design and this study would be acceptable to the patients. Because the — all of this, the details how it would be accepted, retina physicians and to patients, all discussed with this top clinical trialist. And they confirmed they have patients and they have patients enrolled in the trial.

Operator: Thank you. Please hold for our next question. Our next question comes from Yi Chen of H.C. Wainwright.

Chaitanya G: Hey, everyone. Congrats on your progress. This is Chait on behalf of Yi Chen. Just a quick one on TKI. When would you ideally like to initiate the second pivotal study? And then, one on dry eye disease, any comments on the dry eye disease program? I know you indicated that you initiated a small study during the quarter evaluating DED. So any comments on that would be helpful. Thank you.

Antony Mattessich: Hey, Rabia, you want to handle it?