Rishi Singh, MD: Durability of EYP-1901 for Maintenance of nAMD

New findings suggest EYP-1901 achieved sustained delivery of Vorolanib in patients with neovascular age-related macular degeneration (nAMD), with a favorable safety profile at all doses tested.

The data additionally provide premilinary evidence of efficacy for up to 6 months with EYP-1901 alone in nAMD treatment for more than half of the eyes enrolled.

The late-breaking findings were presented at the American Society of Retina Specialists 40th Annual Scientific Meeting.

In an interview with HCPLive, presenting author Rishi Singh, MD, Cleveland Clinic Florida, discussed the challenges retina specialists face, including the durability of current treatments available for nAMD.

"EYP-1901 is a novel look at approaching this from a different angle," Singh said.

The bioerodible insert uses the tyrosine kinase inhibitor (TKI) Vorolanib. In the DAVIO trial, patients were randomized to receive the implant with a single standard-of-care anti-VEGF injection at the time of randomization.

The trial then looked at patients who needed supplemental treatment over the course of one year. The data show a decrease in the treatment burden of these patients requiring supplemental treatment by about 74% at 12 motnhs following the single injection of EYP-1901.

"For the durability issue that we all face in clinical practices has significant promise to reducing the number of visits patients have to have with us and potentially preserving their visual outcomes long term," Singh said.

Singh added that the trial was considered very safe. They additionally looked at a dose escalation study, noting that you may expect a better biological effect in higher doses.

However, the low and middle doses had a better observed biological effect compared to the higher dose.

"That was kind of counterintuitive, but really quite interesting to see," Singh said. "And therefore that's probably the dose they'll be testing in the future phase 2 clinical trials."

They plan to have additional phase 2 studies by the later quarter of this year and early next year in NAMD, diabetic retinopathy, and diabetic macular edema.

He noted that clinicians all face the fact that patients are coming in frequently and the amount of monitoring required is signficant. It is additionally a burden both socioeconomically and for the practices that have to see these patients.

But, the durability and reduction in overall treatment burden observed is significant, Singh said. The DAVIO study results showed that the number of treatments the patients undergo is significantly lower than the prior enrollment

"What we saw in the study results from the DAVIO study showed that in general, the number of treatments these patients undergo is significantly lower than the prior enrollment or prior 12 months prior to enrollment of these patients," Singh added.

"12-Month Results of EYP-1901 Vorolanib in a Bioerodible Durasert Insert for nAMD: The DAVIO Trial," was presented at ASRS 2022.