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EYP-1901 Safe, Tolerable for nAMD at 6 Months

New findings show the investigative single-dose agent is safe and associated with reduced rescue-dose anti-VEGF treatment.

Novel investigative therapy EYP-1901 is associated with favorable safety at 4 observed doses in patient eyes with neovascular age-related macular degeneration (nAMD) at 6 months, according to new findings.

In data presented at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting in Chicago, a team of investigators from Massachusetts observed a consistent safety profile for EYP-1901, a small-molecule tyrosine kinase inhibitor being considered as a maintenance treatment for nAMD in the phase 1 DAVIO trial.

Led by David R. Lally, MD, of the New England Retina Consultants in Springfield, the team sought to observe doses of 440 µg, 1,060 µg, 2,060 µg or 3,090 µg EYP-1901 in patients from the multi center, open-label, dose-escalation DAVIO trial. Their primary endpoints were the rate of ocular and systemic adverse events in treated patients with nAMD, with secondary endpoints including best-corrected visual acuity (BCVA) and key optical coherence tomography (OCT), each through 12 months.

The AAO 2022 data presented included outcomes through 6 months.

Patients were administered a single-dose EYP-1901 administration, with certain clinical criteria required for supplemental anti-VEGF therapy to treat their nAMD.

Their assessment included 17 patients, with a mean age of 77.4 years old and approximately three-fourths female. Mean baseline BCVA was 69 ETDR letters, and mean CST was 299 ucm. Patients had been diagnosed with nAMD for a median 17 months prior to enrollment, and had received a mean 8.6 anti-VEGF injections in the last 12 months.

Among the key primary findings from the assessment were no ocular severe adverse events, no drug-related systemic severe adverse events, and no dose-limiting toxicity observed in patients.

In the secondary endpoints, investigators observed a mean change of -2.5 ETDR letters in BCVA and -3.4 ucm in CST at 6 months.

Investigators observed significant reductions in anti-VEGF injections following EYP-1901 administration in patients from each treatment arm—79% in total. By 6 months, supplemental injection-free rates were 53% among patients.

Through the ongoing 12-month trial, investigators were encouraged by the positive safety outcomes and associated tolerability of EYP-1901.

“EYP-1901 had a favorable safety profile in the doses tested and controlled (neovascular) AMD for 6 months or more in many eyes,” they concluded.

The study, “EYP-1901: An Open-Label, Dose-Escalation Study Demonstrating Reduced Wet AMD Treatment Burden With Sustained TKI Inhibition,” was presented at AAO 2022.