At the 56th annual Retina Society congress in New York, David Boyer, MD, gave a presentation titled, "Subgroup analyses of phase 1 DAVIO Trial of EYP-1901 demonstrating reduced treatment burden in wet age-related macular degeneration."
At the 56th annual Retina Society congress in New York, David Boyer, MD, gave a presentation titled, "Subgroup analyses of phase 1 DAVIO Trial of EYP-1901 demonstrating reduced treatment burden in wet age-related macular degeneration." He spoke with the Managing Editor of Ophthalmology Times, David Hutton, to share some key insights from his presentation.
Editor's note - This transcript has been edited for clarity.
David Hutton: I'm David Hutton of Ophthalmology Times. The Retina Society's annual meeting recently was held in New York. At that meeting, Dr David Boyer presented, "Subgroup analyses of phase 1 Davino trials EYP-1901, demonstrating reduced treatment burden and wet age-related macular degeneration. Dr Boyer, thanks so much for joining us today. Tell us about this presentation.
David Boyer, MD: On behalf of all the investigators and the patients involved, EYP-1901, used of vorolanib and the durasert bio-erodible delivery system. Vorolanib is a potent selected, pan-VEGF receptor inhibitor. And the durasert technology allows zero order kinetics to allow, over a 9 month period, the release of this medication we know durasert has been established with 4 previous FDA programs. So it's, it's very well known. There's confidence in this drug.
So there are 4 doses basically, that were tested, and essentially, the patients were enrolled, they all had to have previously-treated wet macular degeneration. The fluid status at the time of the study did not exclude patients who had had a fluid at the time of the baseline. So patients can come in dry or wet. The minimum of 3 anti-VEGF injections were mandated. However, you'll see that most of these patients required almost 6 injections and the criteria for supplemental injection was 75 microns of fluid, or loss of 10 letters from day zero. Single intravitreal aflibercept injection was given. And then 7 to 10 days later, there was a single injection of EYP-1901.
And as you know from almost all the studies, a phase 1 study looks for the patient safety. The DAVIO participants were what you would have expected in normal trial: About 77 years of age, mostly females, the visions were about 69 microns, 69 letters, the mean SST was about 300, and most of the patients were previously treated approximately 8.6 injections in the previous month.
The good news is there were no safety features. There [were] no signs of an ocular SAE, no drug-related, ocular, systemic SAEs, no vasculitis. There was no dose limiting toxicity. There was no vitreous floaters, retinal detachment, [or] migration of the implant. And a majority of the of the of the AEs were very mild. The good news, as far as the efficacy, there was a stable vision both best-corrected vision from the screening visit, as well as the CST throughout the course of the study over a 12 month period. And as I said, these were extremely well-treated patients in the first year, and they were able to reduce the, basically the treatment burden in these patients by up to 75%. If they came in dry, at the time of the first injection, about 50% of patients were injection free at 6 months and 35% were actually never required additional treatment. So the burden was reduced tremendously by using this drug, and very few rescues were necessary. When you looked at eyes that were there, was no fluid at screening, about 90% of 5 months did not have any fluid and about 67% of that had no fluid at 6 months.
Basically the the results of this indicate, you know, a very safe treatment that may reduce the need for additional treatment. The injection-free interval at 6 months was reduced by 75% in 6 months and 73% in 12 months, and if you look at the patients that did have any fluid at the time of the screening exam, it was 92%. So basically based on this because of good safety, the DAVIO-2 trial was started, completely enrolled, and we'll have the results of that at the end of the year.