EyePoint Announces Topline Data from LUGANO, the First of Two Pivotal Phase 3 Clinical Trials for DURAVYU™ 2.7mg in Wet AMD
EyePoint reported topline results from the LUGANO Phase 3 trial of DURAVYU in wet AMD, missing the primary endpoint of change in Best Corrected Visual Acuity in the full dataset. The company attributes the miss to a 4% asymmetric cohort that experienced vision loss unrelated to wet AMD, noting an ad hoc analysis excluding these patients showed non-inferiority to aflibercept. Key secondary endpoints demonstrated superiority, including a 42% reduction in treatment burden and favorable safety profiles compared to the control arm. 54% of DURAVYU patients remained supplement-free through Week 56, and 79% received zero or one supplemental injection.
Key figures
- Drug Name
- DURAVYU™ (vorolanib intravitreal insert)
- Phase Of Trial
- Phase 3
- Cst difference microns
- 4
- Supplement free week 32
- 76%
- Supplement free week 56
- 54%
- Treatment burden p value
- <0.0001
- Asymmetric cohort patients
- 9 of 211
- Treatment burden reduction
- 42%
- Asymmetric cohort percentage
- 4%
- Zero or one supplement week 56
- 79%
- Primary endpoint ad hoc p value
- 0.0096
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.