Trial results for the Phase 2 study of EYP-1901 in patients with nonproliferative diabetic retinopathy (NPDR) were posted on ClinicalTrials.gov on 2025-07-28. The study evaluated two doses of EYP-1901 intravitreal insert against sham, with improvement rates ranging from 0% to 5.3% across treatment arms at various time points.
Background
Nonproliferative diabetic retinopathy (NPDR) is an eye condition that can lead to vision loss, often associated with diabetes. EYP-1901 is an investigational intravitreal insert being evaluated for its potential to treat this condition.
Trial design
The study (NCT05383209) was a Phase 2, prospective, randomized, double-masked trial that enrolled 77 participants with nonproliferative diabetic retinopathy. The trial evaluated two doses of the EYP-1901 intravitreal insert (2060 mcg and 3090 mcg) compared to a sham injection.
Key results
The trial evaluated the percentage of subjects who achieved an improvement of >=2 steps from baseline in the DRSS (Diabetic Retinopathy Severity Scale) score at various time points.
- At Week 36, for the outcome "Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score":
- The sham injection group showed an improvement in 5.0% of subjects.
- The EYP-1901 2060 mcg group showed an improvement in 0% of subjects.
- The EYP-1901 3090 mcg group showed an improvement in 4.8% of subjects.
- For the outcome "Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 24 and Week 48":
- At Week 48, the EYP-1901 3090 mcg group showed an improvement in 5.3% of subjects, while the sham injection group showed 0% improvement at both Week 24 and Week 48.
- The EYP-1901 2060 mcg group showed 0% improvement at both Week 24 and Week 48.
- The EYP-1901 3090 mcg group showed 0% improvement at Week 24.
- For the outcome "Percentage of Subjects Improved >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48", all groups (Sham Injection, EYP-1901 2060 mcg, and EYP-1901 3090 mcg) showed 0% improvement.
Key analyses included a difference in response percentage of -5.0 (95.0% CI: -24.9 to 13.4) and another difference in response percentage of 5.3 (95.0% CI: -13.2 to 26.0).
What this means
The results from this Phase 2 study indicate that EYP-1901 did not demonstrate a consistent or substantial improvement in DRSS scores compared to sham in patients with nonproliferative diabetic retinopathy. While one dose showed a 5.3% improvement at Week 48 compared to 0% for sham at that time point, other measurements showed similar or lower improvement rates for EYP-1901 compared to sham. The wide confidence intervals for the observed differences suggest that further research would be needed to establish any definitive benefit.
Source
The information for this article was sourced from ClinicalTrials.gov, a public database of clinical studies. The trial results for study NCT05383209, titled "Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)," were posted on 2025-07-28 on clinicaltrials.gov.