Clinical Report: New Data for Bioerodible DURAVYU in Wet AMD

Overview

The Phase 3 LUGANO trial of DURAVYU (EYP-1901) did not meet its primary endpoint for mean change in best-corrected visual acuity (BCVA) compared to aflibercept.

Background

Wet age-related macular degeneration (AMD) is a leading cause of vision loss in older adults, necessitating effective treatment options. Anti-VEGF therapies are standard, but high treatment burdens can lead to nonadherence. DURAVYU, a bioerodible intravitreal insert, aims to provide sustained release of vorolanib.

Data Highlights

No numerical data available in the source material.

Key Findings

• The primary endpoint of mean change in BCVA was not met in the full dataset of the LUGANO trial.
• Nine patients in the DURAVYU group experienced ≥15-letter vision loss from causes unrelated to neovascular AMD.
• 76% of DURAVYU-treated patients remained supplement-free at Week 32, reducing treatment burden by 42% compared to aflibercept.
• Anatomic disease control was strong, with only a 4 µm difference in CST compared to aflibercept.
• No significant safety signals were identified that could explain the vision loss imbalance.

Clinical Implications

The findings from the LUGANO trial suggest that while DURAVYU may not meet primary efficacy endpoints, it shows promise in secondary outcomes related to treatment burden and anatomic control. Clinicians should consider these factors when evaluating treatment options for wet AMD.

Conclusion

DURAVYU presents a potential alternative for managing wet AMD, with ongoing studies expected to provide further insights into its efficacy and safety.

Related Resources & Content

1. Retinal Physician, Results of Recent Trials of Duravyu for Wet AMD, 2024 -- https://www.retinalphysician.com/issues/2024/october/results-of-recent-trials-of-duravyu-for-wet-amd
2. Retinal Physician, No Changes Advised for Duravyu Wet AMD Studies, 2025 -- https://retinalphysician.com/news/2025/no-changes-advised-for-duravyu-wet-amd-studies
3. Retinal Physician, Duravyu Misses Primary Endpoint in Phase 3 LUGANO for Wet AMD Recommendations, 2026 -- https://www.retinalphysician.com/news/2026/duravyu-misses-primary-endpoint-in-phase-3-lugano-for-wet-amd
4. American Academy of Ophthalmology, Preferred Practice Pattern® Guidelines: Ophthalmology -- https://www.aaojournal.org/content/preferred-practice-pattern?utm_source=openai
5. Retinal Physician — No Changes Advised for Duravyu Wet AMD Studies
6. Preferred Practice Pattern® Guidelines: Ophthalmology
7. DailyMed - EYLEA- aflibercept injection, solution
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9. DailyMed - EYLEA HD- aflibercept injection, solution
10. TENAYA and LUCERNE - Ophthalmology
11. Intravitreal Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration: Ninety-Six-Week Results from the Randomized Phase 3 PULSAR Trial - PubMed
12. Comparative efficacy of intravitreal anti‐VEGF therapy for neovascular age‐related macular degeneration: A systematic review with network meta‐analysis - PMC
13. www.sec.gov