EyePoint’s stock dropped 67% after its potential Eylea (aflibercept) competitor Duravyu fell short in a Phase III trial that pitted the drugs against each other in wet age-related macular degeneration (wet AMD).
In the LUGANO (NCT06668064) study, Duravyu (vorolanib intravitreal insert) failed to meet its primary endpoint of non-inferiority in mean change in best corrected visual acuity (BCVA) after one year compared to Regeneron Pharmaceuticals and Bayer’s Eylea, which is the current standard of care (SoC).
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The company added that nine of 211 patients in the experimental treatment group experienced vision loss unrelated to wet AMD, versus none in the control arm. An ad hoc analysis considering this would see the drug achieve non-inferiority.
After this data was released, the company’s stock dropped 66.98% on 17 August, from a 14 August close of $14.75 to a 17 August close of $4.87. EyePoint, which is listed on the Nasdaq exchange, has a market cap of $419.85m.
Despite the miss, the LUGANO trial did produce some clinically meaningful data. This includes 76% of Duravyu patients being supplement-free at week 32 and 94% of Duravyu patients having received zero or one supplement in the same period.
At 56 weeks, 54% of Duravyu patients were supplement-free while 79% had received one or fewer supplements.
EyePoint highlighted a favourable safety profile with redosing, with no difference in cataracts, elevated intraocular pressure, or intraocular inflammation between the study and control group.
Dr Carl Regillo, professor of ophthalmology at Thomas Jefferson University and co-chair of EyePoint’s scientific advisory board, said: “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 plans to present additional details on the LUGANO dataset, including subgroup analyses, at the Retina Society 59th Annual Scientific Meeting from 23-26 September.
Duravyu is being investigated in a second wet AMD trial, the Phase III LUCIA study, with topline data expected in the fourth quarter of 2026.
If successful, EyePoint plans to submit a New Drug Application (NDA) for Duravyu in the treatment of wet AMD to the US Food and Drug Administration (FDA) in the first half of 2027.
Topline data from EyePoint’s pivotal Phase III programme of Duravyu in diabetic macular oedema (DME) is anticipated in the fourth quarter of 2027.
Eylea, a blockbuster vascular endothelial growth factor (VEGF) inhibitor, generated $4.4bn in sales in 2025 – a 27% decrease compared to 2024. This drop is due to generics entering the market amid patent expirations.
According to a GlobalData report in December 2025, the AMD market in the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan) is set to grow from $7.8bn in 2024 to $20.5bn in 2034, driven by the entry of therapies with longer durations, new mechanisms of action, the availability of therapies for geographic atrophy (GA), and the launch of the first therapy for early AMD, which will increase treatment options available for patients with this sub-indication.
Specifically in the wet AMD space, GlobalData highlighted EyePoint’s Duravyu as well as Ocular Therapeutix’s Axpaxli (axitinib SR) as two new tyrosine kinase inhibitors (TKIs) set to impact the market.
Other therapies set to launch in the wet AMD market before 2034 include Ashvattha Therapeutics’ D-4517, which is a platelet-derived growth factor receptor (PDGFR) inhibitor and VEGF inhibitor; and Merck’s MK-3000, which is a wingless-related integration site (wnt) agonist therapy.
GlobalData is the parent company of Clinical Trials Arena.
