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David Lally, MD: Insights into Safety Data on EYP-1901 for nAMD

Safety data of the bioerodible sustained delivery intravitreal anti-VEGF treatment indicate no ocular or systemic serious adverse events with mild adverse events.

Although anti-VEGF therapies for neovascular age-related macular degeneration (nAMD) have proven to be strong in terms of both efficacy and safety, the treatment burden of frequent injections remains a challenge.

Sustained delivery is thus a logical step forward to ease the difficulties patients face in their treatment. EYP-1901 is a new approach with sustained delivery intravitreal anti-VEGF treatment, combining a bioerodible insert (Durasert) with vorolanib, a tyrosine kinase inhibitor.

In an interview with HCPLive, David Lally, MD, Director of the Retina Research Institute, New England Retina Consultants, discussed the phase 1 DAVIO trial investigating EYP-1901 for the treatment of nAMD and its primary safety outcomes at month 12.

“We saw the safety was excellent with no ocular or systemic serious adverse events (SAE),” Lally said. “The adverse events (AEs) were mild in the majority of the eyes and consistent with other intravitreal therapies that we use. There were no signs of inflammation or endophthalmitis, and patients were not visualizing the implant.”

As the study included previously treated nAMD eyes, investigators did not expect to see visual improvement. The data show the mean change in baseline visual acuity was –4 letters, which Lally noted was not a meaningful difference. Similarly, the change in central subfield thickness remained unchanged as investigators expected.

Lally did add that the most encouraging efficacy signal from the trial was the rate of rescue free anti-VEGF injections. In the DAVIO trial, over half of eyes did not require a rescue anti-VEGF up to month 6 and a third of eyes did not require a rescue anti-VEGF up to month 12.

“To put this in perspective, these patients had on average 8.6 anti-VEGF injections in the year leading up to the enrollment in the DAVIO trial,” he said. “And so that's quite a reduction in the treatment burden for those patients, at least in this core cohort, with these doses over the following year.”

The phase 2 DAVIO trial will include patients with persistent retinal fluid and a history of anti-VEGF therapy treated for nAMD will be randomized to one of two doses of EYP-1901 or aflibercept treated on label for nAMD.

Lally additionally spoke more to treatment burden being the highest unmet need in clinics. Patients receive an average of 6 injections per year, dealing with a discomforting needle and the procedures can cause anxiety for patients.

“Often I find I walk into the room and they don't have a lot to say until after I give them the injection,” Lally said. “As the physician I can sense that anxiety within them has been relieved once the procedures have been completed.”