Jay S. Duker, MD, chief operating officer of EyePoint Pharmaceuticals, highlights the Phase 1 and Phase 2 DAVIO clinical trials for EYP-1901 in wet age-related macular degeneration. The company also announced the first patient has been dosed in the Phase 2 PAVIA trial of EYP-1901 for nonproliferative diabetic retinopathy.
Note: This transcript has been lightly edited for clarity.
Jay S. Duker, MD: Hello, I'm Jay Duker. I'm the Chief Operating Officer of EyePoint Pharmaceuticals. I'd like to talk to you today about our lead product in the pipeline, EYP-1901.
EYP-1901 is a small-molecule tyrosine kinase inhibitor called vorolanib, which is in our proprietary Durasert insert. The Durasert insert that we're using is bioerodible. Our Phase 1 study was completed several months ago. It was called the DAVIO trial, and it enrolled 17 patients with previously treated wet age-related macular degeneration to 4 dosing cohorts. This was a single intravitreal injection done in the doctor's office. There was no control group. There was no reinjection of EYP-1901 during the study.
The primary results of any Phase 1 study is safety and our safety profile was quite good. We had no ocular SAEs [serious adverse events]. We had no drug-related systemic SAEs. The ocular AEs [adverse events] were generally mild and due to the injection and cleared without any sequelae. From an efficacy perspective, we showed stable visual acuity in OCTs through 1 year. Another look at efficacy would be the reduction in treatment burden. In other words, how many injections were the patients getting prior to EYP-1901 versus after. We had over a 70% reduction in treatment burden over the entire year of the study.
The rescue free rate at 4 months was up to 76%. At 6 months, it was up to 53% and almost one-third of the eyes went the full year without any supplement anti-VEGF injection. Subgroup analysis showed that eyes that entered the study dry with no excess fluid did exceptionally well with a 92% reduction in treatment burden and over 50% of the eyes going to full year without supplement.
We're very excited about the program. We've initiated a Phase 2 DAVIO2 trial in wet macular degeneration that enrolled the first patient 2 months ago. Last week we enrolled our first patient in the PAVIA trial, which is using EYP-1901 in nonproliferative diabetic retinopathy. I look forward to sharing results of those trials in the future. Thank you.