Contradictions Unveiled: Regulatory Strategies and Trial Timelines in Latest Biopharma Call

Phase III Trial Progress and Enrollment:
- EyePoint successfully completed full enrollment for both LUGANO and LUCIA pivotal trials, enrolling over 800 patients across trials.
- The rapid enrollment was driven by efficient trial design and excellent collaboration with clinical sites and investigators.

Financial Performance and Cash Runway:
- EyePoint ended Q2 2025 with $256 million in cash and investments, affirming previous cash runway guidance into 2027.
- The increase in clinical trial costs, primarily driven by the Phase III trials, was offset by disciplined financial management and efficient enrollment.

DURAVYU's Efficacy and Safety Profile:
- DURAVYU demonstrated statistically non-inferior visual acuity compared to on-label aflibercept, with a treatment burden reduction of over 80%.
- This compelling safety and efficacy profile has been established through extensive clinical data, including over 190 patients treated across multiple retinal indications.

Regulatory Strategy and Timeline:
- EyePoint anticipates LUGANO top-line data in mid-2026, with LUCIA to follow shortly thereafter, positioning them first to file and potentially first to market.
- This timeline is supported by the rapid enrollment, efficient trial design, and alignment with regulatory agencies like the FDA and EMA.