Clinical Report: EYP-1901 for Retinal Exudative Diseases

Overview

EYP-1901, a novel intravitreal insert, demonstrates noninferiority to aflibercept in treating wet AMD, indicating it is at least as effective. It significantly reduces treatment burden, with an 89% reduction in the 2 mg arm and 85% in the 3 mg arm. Ongoing Phase 3 trials aim to further establish its efficacy and safety in retinal exudative diseases.

Background

Current anti-VEGF therapies for wet AMD and DME often lead to high treatment discontinuation rates due to the burden of frequent injections. These therapies primarily target angiogenesis, leaving inflammation unaddressed, which is crucial in disease progression. There is a pressing need for more durable treatment options that address multiple aspects of disease pathogenesis. EYP-1901 offers a promising solution with its sustained release formulation and multi-mechanism action.

Data Highlights

Key Findings

• EYP-1901 demonstrated statistical noninferiority to aflibercept in BCVA change in the DAVIO 2 trial, suggesting comparable efficacy.
• Patients receiving EYP-1901 experienced an 89% and 85% reduction in treatment burden in the 2 mg and 3 mg arms, respectively, which could enhance patient adherence.
• Phase 3 trials LUGANO and LUCIA are ongoing, with enrollment complete and topline data expected in mid-2026.
• In the VERONA trial, EYP-1901 showed early and sustained vision improvement compared to aflibercept, indicating potential long-term benefits.
• No safety signals were reported across the completed clinical trials for EYP-1901, supporting its safety profile.

Clinical Implications

EYP-1901 may provide a significant advancement in the management of wet AMD and DME by reducing the frequency of injections required. Its multi-mechanism action could address both angiogenesis and inflammation, potentially improving long-term patient outcomes and changing treatment paradigms.

Conclusion

EYP-1901 represents a promising new treatment option for retinal exudative diseases, with ongoing trials set to confirm its efficacy and safety profile. Its ability to reduce treatment burden may enhance patient adherence and outcomes, potentially influencing future treatment guidelines.

References

1. EyePoint Pharmaceuticals, New Retinal Physician, 2024 -- EyePoint Presents EYP-1901 Data for Wet AMD
2. Jim Gallagher, Retinal Physician, 2025 -- EYP-1901 Shows 9-Month Disease Control in NPDR Patients
3. The Ophthalmologist, 2026 -- EYP-1901 in Wet AMD and DME: Insights from the Phase 2 DAVIO 2 and VERONA Trials
4. AAO Age-Related Macular Degeneration Guideline Summary, Guideline Central -- 2025
5. retinal physician — EYP-1901 Shows 9-Month Disease Control in NPDR Patients
6. EyePoint Pharmaceuticals - Clinical Data
7. EyePoint Pharmaceuticals - VERONA Trial Data
8. AAO Age-Related Macular Degeneration Guideline Summary - Guideline Central