ARVO LIVE: OTX-TKI phase 1 study update

Ophthalmology Times® talked with Andrew Moshfeghi, MD, MBA, about OTX-TKI in a phase 1 study looking at patients with neovascular AMD this year's ARVO meeting.

Video transcript

Editor’s note: Transcript lightly edited for clarity.

Andrew Moshfeghi, MD, MBA:

I'm here in New Orleans at the ARVO 2023 annual meeting. I had the opportunity to share our data on OTX-TKI in a phase 1 study looking at patients with neovascular AMD. So we shared our data up through 10 months.

This is an interim analysis for this phase 1 prospective, randomized and controlled study. And we also shared some previously unreported data, evaluating pharmacokinetic data in 2 different animal models.

I'll start with that first, because that kind of is the predicate for moving forward with human studies. And what we found in those data was that there's consistently over 100 fold increase over the minimum inhibitory concentration necessary to control the deleterious effects of angiogenesis including vascular leakage and the other effects of CMV formation in non-human primates and also in rabbit model. And this was over many months after intravitreal administration.

What we found with the phase 1 clinical trial was that there is, in patients who have controlled neovascular AMD at baseline, OTX-TKI was able to continue to control it. Such that basically 80% of patients through 6 months did not require any rescue aflibercept therapy. And 73% of patients up through 10 months did not require any rescue therapy, as based upon pre-specified rescue criteria and also based upon investigator discretion. What we also found was that the visual acuity and OCT outcomes were similar to the aflibercept control arm through that same time period.

So these data represent really strong evidence to move forward with additional pivotal studies in neovascular AMD and it's also being looked at as a way of managing nonproliferative diabetic retinopathy that's at the moderately severe to severe level. And in patients who don't have diabetic macular edema, so it's not going to be looking at DME treatments, really more nonproliferative diabetic retinopathy by itself. We look forward to coming back and reporting on those data later.