EyePoint's Duravyu meets primary endpoint in Phase 2 DME trial, showing potential to compete with Regeneron's Eylea and Roche's Vabysmo in the eye disease market.

EyePoint (Nasdaq:EYPT) reported topline results from LUGANO, the first pivotal Phase 3 trial of DURAVYU™ 2.7mg in wet AMD versus on‑label 2 mg aflibercept. The primary endpoint (BCVA change) was not achieved in the full dataset, affected by a 4% asymmetric cohort (9/211 DURAVYU patients) with ≥15‑letter vision loss unrelated to wet AMD; no such cases occurred in the aflibercept arm. An ad hoc analysis excluding this cohort showed non‑inferiority for DURAVYU (nominal p=0.0096).Key secondary endpoints favored DURAVYU, including a 42% reduction in treatment burden (two fewer injections on average; p<0.0001), high supplement‑free rates (76% to Week 32; 54% to Week 56; 79% with 0–1 supplement to Week 56), non‑inferior BCVA in supplement‑free patients (p=0.0035), strong anatomic control with a 4‑micron CST difference at Week 56 (3 microns in supplement‑free eyes), and a favorable safety profile with repeat dosing. EyePoint expects topline data from the second pivotal wet AMD trial, LUCIA, in Q4 2026 and is planning a potential FDA NDA submission for DURAVYU in 1H 2027, pending those results. Phase 3 DME trials COMO and CAPRI have fully enrolled, with topline data anticipated in Q4 2027.

EyePoint Pharmaceuticals is attempting to salvage its lead drug candidate, DURAVYU, by characterizing a failed Phase III trial as a statistical anomaly. The company is now focusing on secondary endpoints and a second upcoming study. The LUGANO trial, which evaluated the drug for wet age-related macu

Kessler Topaz Meltzer & Check, LLP is investigating possible securities violations by EyePoint, Inc. after the stock plummeted 66% due to unfavorable trial results.

Kessler Topaz Meltzer & Check, LLP is investigating EyePoint, Inc. following disappointing Phase 3 trial results. Investors may have legal options.

Although the trial did not meet its primary endpoint, EyePoint reported a 42% reduction in overall treatment burden, with most patients requiring zero or one supplemental injection through Week 56.

EyePoint Pharmaceuticals' shares plummeted by around 70% after failing to meet crucial trial endpoints. Investors are urged to seek restitution.

The phase 3 LUGANO trial investigating Duravyu for wet AMD did not meet its primary endpoint in the full dataset but showed positive results in treatment burden, supplement-free rates and anatomic control, according to a press release. The randomized, double-masked, noninferiority LUGANO and LUCIA programs are investigating the safety and efficacy of Duravyu (vorolanib intravitreal insert, EyePoint Pharmaceuticals) vs. on-label aflibercept 2 mg as a treatment for wet age-related macular degeneration, with more than 900 patients enrolled across both trials. The primary endpoint looked at

The phase 3 LUGANO trial investigating Duravyu for wet AMD did not meet its primary endpoint in the full dataset but showed positive results in treatment burden, supplement-free rates and anatomic control, according to a press release. The randomized, double-masked, noninferiority LUGANO and LUCIA programs are investigating the safety and efficacy of Duravyu (vorolanib intravitreal insert, EyePoint Pharmaceuticals) vs. on-label aflibercept 2 mg as a treatment for wet age-related macular degeneration, with more than 900 patients enrolled across both trials. The primary endpoint looked at

RBC Capital downgrades its rating on EyePoint Pharmaceuticals to Sector Perform from a previous Outperform rating. EyePoint is a pharmaceutical company that develops treatments for serious eye…

EyePoint DURAVYU misses primary endpoint in LUGANO Phase 3 for wet AMD. Strong secondaries: 42% treatment burden reduction, favorable safety.

EyePoint's vorolanib (Duravyu) failed Phase 3 LUGANO trial vs Regeneron/Bayer's Eylea, sending $EYPT shares down 70%. Second study LUCIA results expected Q4.

Reported Monday, Aug 17 - 8:42am EDT (TheFly subscription required to read more.)

EyePoint (Nasdaq:EYPT) reported second quarter 2026 net revenue of $0.5 million, down from $5.3 million a year earlier, with operating expenses of $97.9 million and a net loss of $94.5 million ($1.09 per share). Cash, cash equivalents and marketable securities totaled $180 million as of June 30, 2026, which the company expects will fund operations into the fourth quarter of 2027.EyePoint highlighted progress for lead candidate DURAVYU (vorolanib intravitreal insert). Topline data from the pivotal Phase 3 LUGANO wet AMD trial are expected in August 2026, with LUCIA data anticipated in Q4 2026. Pivotal Phase 3 DME trials COMO and CAPRI have fully enrolled over 480 patients, with topline data expected in Q4 2027. A May 2026 DSMC review recommended LUGANO and LUCIA continue without protocol changes, with masked safety data consistent with prior favorable experience. The company is scaling its commercial manufacturing facility and appointed Tarek S. Hassan, M.D., as Chief Strategic Science Officer in July 2026.

– COMO and CAPRI trials together rapidly enrolled over 480 participants in five months, demonstrating continued enthusiasm for DURAVYU trial participation among retinal specialists and patients –– – Topline 56-week data for both DME trials anticipated in 4Q 2027 – WATERTOWN, Mass., July 30, 2026