EyePoint Pharmaceuticals received a second consecutive positive recommendation from its independent Data Safety Monitoring Committee for the company’s pivotal Phase 3 program evaluating DURAVYU in wet age‑related macular degeneration. The recommendation, based on data up to the September 29 2025 cutoff, confirms that all patients in the LUGANO and LUCIA trials have reached the Week 8 visit and that roughly 25 % have received the planned Week 32 redosing. No protocol modifications were advised, indicating that the safety profile remains consistent with earlier studies and that the study can continue without change.
The DSMC’s endorsement is a key regulatory milestone that can accelerate EyePoint’s path toward a potential FDA submission. With topline 56‑week data for LUGANO expected in mid‑2026 and LUCIA data to follow shortly thereafter, the recommendation reinforces confidence that DURAVYU’s sustained‑release delivery platform is performing as intended in a large, pivotal trial setting. The decision also signals to investors that the clinical program is on track and that the company’s proprietary Durasert E technology is delivering the anticipated safety and dosing profile.
Financially, EyePoint’s Q3 2025 results showed a revenue miss, with earnings of $0.966 million compared to $10.5 million in Q3 2024, and a widened net loss of $59.7 million versus $29.4 million the prior year. The decline reflects lower revenue from non‑clinical segments and higher operating expenses driven by Phase 3 trial costs. However, the company secured a substantial capital raise in October 2025 that extends its cash runway into Q4 2027, providing the liquidity needed to fund ongoing clinical programs through the critical data readouts.
Chief Medical Officer Ramiro Ribeiro said, “We are pleased to receive our second consecutive positive recommendation from the DSMC for our pivotal wet AMD program. Now that all patients are past initial dosing and a growing number have received redosing, this recommendation strengthens our confidence in DURAVYU’s consistent, favorable safety profile observed across its robust development history.” President and CEO Jay S. Duker added, “With topline data from our LUGANO trial expected in mid‑2026 and LUCIA to closely follow, we believe we are well positioned for DURAVYU to be first to file and first to market among all investigational sustained‑release programs in this indication.”
Looking ahead, EyePoint plans to report the LUGANO 56‑week data in the second half of 2026, followed by LUCIA data shortly thereafter. The company’s strategy focuses on leveraging the Durasert E platform to reduce the treatment burden for patients with wet AMD, potentially offering a more convenient and effective alternative to current frequent intravitreal injections. The sustained‑release approach could capture a significant share of the $10 billion+ wet‑AMD market if regulatory approval is achieved, positioning EyePoint as a leader in retinal therapeutics.
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