Vascular endothelial growth factor inhibitors(Bayer HealthCare AG)

iStock, fotographic1980 EyePoint’s quest to reduce treatment burden for patients with age-related macular degeneration has hit a bump in the road, with a clinical miss driving the biotech’s stock down by 70%. EyePoint’s late-stage eye candidate has failed to beat approved treatment aflibercept in improving vision for patients with wet age-related macular degeneration, putting pressure on an upcoming readout for the same asset. Lugano , a Phase 3 trial of about 400 patients, tested EyePoint’s investigational tyrosine kinase inhibitor (TKI) duravyu against the standard-of-care aflibercept, a vascular endothelial growth factor (VEGF) inhibitor marketed by Regeneron Pharmaceuticals as Eylea and also sold by a handful of biosimilars makers. The trial’s main goal was improving average change in vision after two years, as measured by best corrected visual acuity (BCVA) using an eye chart. The primary endpoint wasn’t met and EyePoint failed to share any other information around the miss in a Monday press release . Subsequently, the biotech’s stock crashed 70% at market open, falling to $4.28 per share as of 10 a.m. ET. In a presentation for an accompanying investor call, EyePoint revealed that the BCVA mean change from baseline was above five points for aflibercept, as compared to a change between zero and five points for duravyu. Again, the biotech didn’t share specific figures behind the data. Instead, the company touted findings from an ad hoc analysis that removed nine of 211 patients receiving the investigational treatment who had experienced vision loss of 15 or more letters “for reasons unrelated to wAMD.” The company said these patients “confounded” a primary endpoint win, adding that when they were removed, duravyu was non-inferior to aflibercept. None of the patients in the aflibercept arm experienced vision loss equal to or greater than 15 letters that was unrelated to AMD. The Massachusetts-based biotech noted that 3–5% of patients taking aflibercept typically have lost 15 or more BCVA letters in past Phase 3 trials, implying an unusually clean—and possibly over-performing—control arm, according to Mizuho analysts. That framing is “plausible,” the analysts said in a Monday note, but questions remain about what caused vision loss for the nine patients receiving duravyu. Clinical research 5 Clinical Readouts to Watch in H1 2026 As 2026 begins, a slate of high-stakes clinical readouts—from a pivotal study of Novartis’ cardiovascular candidate pelacarsen to a Phase III test of Eli Lilly’s next-gen Alzheimer’s drug—are poised to reshape therapeutic landscapes. January 5, 2026 · 7 min read · Ben Hargreaves Read more EyePoint also trumpeted “positive” secondary endpoints, such as a 42% reduction in treatment burden, as compared to Mizuho analysts’ 30–35% expectation. The finding was superior to Eylea, equating to almost two fewer injections through week 56, according to EyePoint. That improvement contributes to “excellent” secondary-endpoint data, Mizuho wrote Monday, while calling the overall readout “mixed.” Other secondary data include a clean safety pro high supplement-free rates for patients on duravyu up to week 32. Additional details from Lugano are expected to be shared at the Retina Society 59th Annual Scientific Meeting in Los Angeles in late September. Now, all eyes turn to Lugano’s twin trial, Lucia. A clean win in the identically designed late-stage study would “substantially de-risk the ad hoc narrative” and support EyePoint’s new drug application filing that is planned for the first half of next year, Mizuho wrote. “A second miss would be far more problematic,” the analysts wrote. “The secondaries reinforce duravyu’s differentiated durability and safety,” Mizuho explained. “But the primary miss is a genuine overhang we can’t fully dismiss until LUCIA.” Topline data from Lucia are expected in October. Drug Development EyePoint Pharma Stock Surges on Phase II Wet AMD-Therapy Results EyePoint Pharmaceuticals’ treatment for wet age-related macular degeneration showed comparable results to Regeneron’s Eylea with a less frequent dosing regimen. December 4, 2023 · 2 min read · Connor Lynch Read more EyePoint’s mixed readout is good news for Ocular Therapeutix, a direct competitor touting its own TKI candidate called axpaxli for wet AMD. Both biotechs aim to reduce the frequency, and therefore burden, of anti-VEGF injections. After reporting Phase 3 findings earlier this year, Ocular said recently that a new drug application was on track to be submitted to the FDA in the fourth quarter of this year. The late-stage trial met its primary endpoint, with 74.1% of subjects in the axpaxli arm maintaining vision at week 36, a statistically significant 17.5% risk difference compared to aflibercept. Ocular opened up more than 6% on Monday at $10.72 per share.