EyePoint Positions DURAVYU as a Potential Treatment for Wet AMD
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.
U.S.-based clinical-stage biopharma, EyePoint, has announced topline data from the first of its two pivotal Phase III trials, LUGANO, in an Aug. 17, 2026 press release (1). The late-stage clinical trials are evaluating the safety and efficacy of the company’s investigational, sustained-delivery eye insert, DURAVYU, in patients with active wet age-related macular degeneration (wet AMD).
Wet AMD is a progressive eye disease that damages the macula and is a leading cause of rapid central vision loss in older adults. In the wet form of the disease, abnormal blood vessels grow under the macula and leak fluid or blood, causing rapid central vision loss if untreated. The disease is typically managed with repeated intravitreal injections of anti-vascular endothelial growth factor (VEGF) drugs (2).
DURAVYU combines vorolanib with EyePoint’s bioerodible Durasert E implant and is designed for administration as a single injection to deliver sustained medication over approximately six months. The LUGANO trial compared DURAVYU given roughly every six months against on-label aflibercept, the current standard anti-VEGF injection treatment for wet AMD.
The trial’s primary endpoint — non-inferiority in average change in best-corrected visual acuity (BCVA, a standard eye-chart measure of vision) at weeks 52 and 56 versus aflibercept — was not met in the full dataset. EyePoint attributed this result to an asymmetric cohort of nine patients (~4% of the DURAVYU arm) who lost significant vision for reasons the company reports were unrelated to wet AMD or DURAVYU; no such cases occurred in the aflibercept arm. In an ad hoc analysis that excluded these nine patients, DURAVYU met non-inferiority, with the company also noting the aflibercept control group performed better than historical expectations to further compress the margin for showing non-inferiority (1).
Despite the primary endpoint miss, several secondary outcomes favored DURAVYU against real-world burden and durability. Compared with on-label aflibercept, DURAVYU reduced the overall treatment burden by 42%, resulting in two fewer injections on average through Week 56. Furthermore, 76% of DURAVYU-treated patients required no additional supplemental injections through Week 32, with 54% remaining supplement-free through Week 56.
Overall, 79% of patients received either zero or just one supplemental injection through Week 56. Safety with repeat dosing was favorable, with no notable differences in cataracts, intraocular pressure, or inflammation versus control.
“We are pleased to see that DURAVYU provided clinically meaningful results in the LUGANO trial. The outstanding outcomes across key secondary endpoints, paired with visual improvement, reinforce our confidence in DURAVYU’s potential to transform the current wet AMD treatment paradigm,” said Jay S. Duker, M.D., President and CEO of EyePoint, in the company press release (1). “While the primary endpoint result for the full dataset was unexpected, the consistently positive results from the pre-specified secondary endpoints and the ad hoc analysis on the primary endpoint present a compelling case for DURAVYU as a new potential therapeutic option for wet AMD.”
“DURAVYU demonstrated durable efficacy results with stable retinal anatomy maintained through Week 56, avoiding the sawtooth pattern commonly seen with intermittent anti-VEGF therapy,” added Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer of EyePoint, in the press release (1). “In addition, the supplement-free anatomic and visual outcomes further validate the potency of DURAVYU.”
“The LUGANO results are clinically meaningful because the trial compared DURAVYU to on-label aflibercept, the current gold standard control group in wet AMD trials. Nearly 80% of DURAVYU-treated patients received one or no supplemental injections through Week 56. Disease control with this degree of durability, coupled with a favorable safety profile, would meaningfully reduce the treatment burden for our patients,” explained Carl D. Regillo, M.D., FACS, Former Director of the Wills Eye Hospital Retina Service, Professor of Ophthalmology, Thomas Jefferson University, in the press release (1). “DURAVYU's ability to control disease well in the majority of patients with a six-month redosing interval represents a significant advance for our patients with wet AMD. In clinical practice, keeping patients adequately treated over time is a big challenge, and a sustained delivery option with this kind of profile would be a welcome addition to the armamentarium.”
EyePoint remains on track to report topline data from LUCIA, the second identical Phase III wet AMD trial, in Q4 2026. If LUCIA supports the LUGANO findings, the company plans a potential NDA submission to the FDA in the first half of 2027. EyePoint will present additional details on the LUGANO dataset, including subgroup analyses, at major retina conferences in the coming months, beginning at the Retina Society 59th Annual Scientific Meeting in September.
References
EyePoint. EyePoint Announces Topline Data from LUGANO, the First of Two Pivotal Phase 3 Clinical Trials for DURAVYU 2.7mg in Wet AMD. Press Release, Aug. 17, 2026.
RNIB. Age-Related Macular Degeneration (AMD). RNIB.org.uk (accessed Aug. 18, 2026).