DAVIO trial: 12-month results show favorable safety profile, reduced treatment burden in patients with nAMD

At ASRS 2022 in New York City, New York, Rishi Singh, MD, is presenting, “12-Month Results of EYP-1901 Vorolanib in a Bioerodible Durasert Insert for nAMD: The DAVIO Trial.” The Phase 1 trial showed a reduction in treatment burden over 12 months as well as a favorable safety profile.

Video transcript

Emily Kaiser [EK]: Hello and welcome to our 2022 ASRS coverage. Today I'm speaking with Dr. Rishi Singh about his presentation regarding the 12-month results of the DAVIO trial for neovascular AMD. Dr. Singh, can you tell us more about your presentation?

Rishi Singh, MD [RS]: This was the study of EYP-1901, which is a novel approach to wet macular degeneration. Vorolanib has activity against VEGF receptor as well as PDGF receptor. And it's been studied previously in orally administered patients, where they found anatomical improvements in those patients. Unfortunately, because of the side effect profile of systemic tyrosine kinase inhibitors this study had be stopped.

And so in this case, EYP-1901 is vorolanib now in a Durasert platform, and this is a proprietary platform which shows a sustained delivery technology that allows for a single polyamide shell to be filled with this bioerodible material. And over time, this allows for a zero-order kinetic delivery of the drug into the vitreous cavity and designed for at least six months of delivery, if not longer, depending on the biological response.

The DAVIO study actually looked at this Durasert vorolanib technology in patients with wet macular degeneration—these were previously treated patients—and patients are given either a low, a low-mid dose, a mid dose, or a high dose of vorolanib in this format. And then compared to their previous 12 months where they were receiving anti-VEGF therapy during that period of time.

The study enrolled 17 patients in the first year, and the mean age was around 77 years. Patients on average received 8.6 injections prior to being enrolled within the trial, and the median time for AMD prior to enrollment was 17 months.

And first and foremost, the study's endpoint was looking at the ocular serious adverse events reported, and they were essentially none. There was one patient with a mild amount of inflammation, the other patient had a mild vitreous hemorrhage following the injection procedure, which is probably related to the procedure itself. But again, no significant ocular toxicity found.

But what was incredibly exciting was the amount of reduction of standard-of-care anti-VEGF therapy that the patient saw within the first six months—and again, what we'll report at the ASRS meeting—within the first 12 months, with almost a 74% reduction in the treatment burden of patients at 12 months for those patients within this study.

This is, I think, an unprecedented result for many of the drugs we've ever used in our clinical practices, because very few drugs are able to show that much of a reduction in the burden of treatment that's required in our treatment of neovascular AMD patients.

Of course, because these are previously treated patients, the visual acuities and the OCTs look remarkably similar to when they were in the trial because these are already treated patients; but yet nicely, they were able to show that there was no significant increases or fluctuation for that matter of retinal thickness or vision during the course of the study.

The median time for patients to have a need for rescue treatment, for 50% of the population needed rescue treatment, was in six months. And again, we will present some data at the meeting that will show its overall effect in patients and patient cases, for example.

So just to summarize, again, the safety of EYP-1901 in the DAVIO trial showed a really good safety profile with no drug-related systemic adverse events and no ocular adverse events either. There was a 74% reduction in the treatment burden at 12 months, 29% of supplemental injection-free intervals up to 12 months, and six months in median times of injections of most patients to receive standard-of-care anti-VEGF within that first year of randomization to EYP-1901.

So this is an exciting study and development, and we're going to expect from them a Phase 2 trial as well that's going to look at both what AMD and also an indication for diabetic retinopathy and diabetic macular edema, which is expected in the first quarter of 2023.

EK: Fantastic. Well, thank you so much for telling us about your presentation.

RS: Thanks for having me.

Note: This transcript has been lightly edited for clarity.