ASRS 2024: Single dose of EYP-1901 deemed “non-inferior” to standard of care for patients with wet AMD
A single dose of EYP-1901 plus supplementary standard of care (SOC) treatment resulted in best corrected visual acuity (BCVA) that was statistically non-inferior to aflibercept monotherapy in patients with wet age-related macular degeneration (AMD). The results were presented at the American Society of Retina Specialists Annual Meeting.
The study assessed supplemental injection patterns in patients enrolled in the phase 2, multicenter, prospective, randomized, double-masked, parallel DAVIO 2 study. EYP-1901 provides controlled release of the pan–vascular endothelial growth factor inhibitor vorolanib in Durasert E over at least 6 months.
The DAVIO study assessed the efficacy of a single intravitreal injection of EYP-1901 versus aflibercept in patients with wet AMD. This analysis presented at the ASRS meeting assessed the need for supplemental SOC injections in a subgroup of eyes that were previously treated (n=156) and randomized on day 1 to receive:
- EYP-1901 2,060 μg (n=50)
- EYP-1901 3,090 μg (n=52)
- Aflibercept 2 mg every 8 weeks (SOC; n=54)
All groups received aflibercept 2 mg on day 1 and at weeks 4 and 8. Single-dose EYP-1901 was administered at week 8. All patients could receive supplemental SOC injections.
The averaged mean difference in BCVA at weeks 28 and 32 was –0.3 letters for EYP-1901 2,060 μg and –0.4 letters for EYP-1901 3,090 μg compared with SOC. The mean difference in central subfield thickness was below 10 µm with both EYP-1901 doses at week 32 compared with SOC.
Treatment burden was reduced by 89% and 85% with EYP-1901 2,060 μg and 3,090 μg, respectively, and 65% and 64% of EYP-1901-treated eyes were supplement-free for up to 6 months. About 6% of the aflibercept group required supplemental treatment.
The researchers concluded that there was a “nearly identical BCVA change with EYP-1901 and aflibercept at 12 months.”
Ongoing phase 3 studies are planned for EYP-1901 for wet AMD, with results forthcoming.
Reference
Eichenbaum DA, Hershberger V, Patel S, et al. Assessing supplemental injection use across groups in the phase 2 DAVIO 2 trial of EYP-1901 vs aflibercept in wet age-related macular degeneration. Presented at the ASRS 42nd Annual Meeting, July 17-20, 2024, Stockholm, Sweden.
