Trial results for EYP-1901 in subjects with wet Age-related Macular Degeneration (wAMD) were posted on ClinicalTrials.gov on 2025-10-02. The Phase 2 study compared two dose levels of EYP-1901 against aflibercept, showing comparable average changes in Best Corrected Visual Acuity (BCVA) from baseline. For the 2060 mcg dose, the average change was 1.05 scores, and for the 3090 mcg dose, it was 0.87 scores, compared to 1.17 scores for aflibercept.
Background
Wet Age-related Macular Degeneration (wAMD) is a chronic eye disorder that causes blurred vision or a blind spot in the central vision, often due to abnormal blood vessels leaking fluid or blood into the macula. The EYP-1901 study investigates a potential new treatment for this condition.
Trial design
The Phase 2 randomized, double-masked study (NCT05381948) enrolled 161 participants with wet Age-related Macular Degeneration (wAMD). The trial compared the efficacy of EYP-1901 at two dose levels: 2060 microgram (mcg) and 3090 mcg, against a comparator arm of aflibercept 2mg/0.05ml inj,oph.
Key results
The study's primary focus included the "Average Change in Best Corrected Visual Acuity (BCVA) From Baseline Averaged Over Weeks 28 and 32". The least squares mean changes were:
- Aflibercept 2 mg: 1.17 (Standard Error: 0.830) score on a scale.
- EYP-1901 2060 mcg: 1.05 (Standard Error: 0.866) score on a scale.
- EYP-1901 3090 mcg: 0.87 (Standard Error: 0.841) score on a scale.
Statistical analyses using a Mixed Model for Repeated Measures (MMRM) for this outcome showed no statistically significant differences. The comparison between EYP-1901 2060 mcg and aflibercept 2 mg yielded a Least Square (LS) Mean difference of -0.12 (95.0% CI: -2.48 to 2.24) with a p-value of 0.919. For EYP-1901 3090 mcg versus aflibercept 2 mg, the LS Mean difference was -0.31 (95.0% CI: -2.63 to 2.02) with a p-value of 0.795.
Additional mean changes from baseline in Best Corrected Visual Acuity up to Week 56 were also reported:
- For aflibercept 2 mg, mean changes were 73.4 (Standard Deviation: 9.48), 1.6 (Standard Deviation: 6.81), and 1.1 (Standard Deviation: 8.55) scores.
- For EYP-1901 2060 mcg, mean changes were 73.9 (Standard Deviation: 7.90), 1.0 (Standard Deviation: 6.45), and 0.3 (Standard Deviation: 8.10) scores.
- For EYP-1901 3090 mcg, mean changes were 74.9 (Standard Deviation: 7.68), 0.8 (Standard Deviation: 5.22), and -1.9 (Standard Deviation: 7.83) scores.
What this means
The Phase 2 trial results for EYP-1901 in wet AMD indicate that both tested doses resulted in average changes in Best Corrected Visual Acuity that were numerically comparable to the active comparator, aflibercept, over weeks 28 and 32. The statistical analyses, with high p-values, suggest that there was no statistically significant difference in visual acuity outcomes between EYP-1901 and aflibercept in this study. These findings provide initial efficacy data for EYP-1901 as a potential treatment for wAMD.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05381948, titled "Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)," were posted on 2025-10-02 on clinicaltrials.gov.