By Connor Lynch

Pictured: A patient being examined by an eye doctor

EyePoint Pharmaceuticals marked a major win Monday, with Phase II results of its anti-VEGF therapy for wet age-related macular degeneration showing comparable results to Regeneron’s Eylea on a less-frequent dosing regimen.
Share prices jumped over 200% in premarket trading on the news that EYP-1901 had hit all primary and secondary endpoints in the DAVIO 2 trial.
The trial was investigating EyePoint’s EYP-1901 therapy, an “investigational sustained delivery maintenance treatment” for wet age-related macular degeneration (AMD) that combines vorolanib, a selective tyrosine kinase inhibitor, with “bioerodible Durasert E,” an injectable drug delivery system. The study tested two doses of the therapy, both 2 mg and 3 mg in 160 patients, finding both met all of the primary and secondary endpoints.
That included the primary endpoint of “statistical non-inferiority change in best corrected visual acuity,” compared to the control of Regeneron’s aflibercept, sold as Eylea. The therapy also had a “favorable safety profile with no EYP-1901-related ocular or systemic serious adverse events,” EyePoint said in a release.
Both doses also hit three secondary endpoints: a reduction in treatment burden of over 80%; nearly two-thirds of eyes were supplement-free for up to six months; and over 80% of eyes receiving only one or no supplements for up to six months.
Jay Duker, EyePoint CEO, said the results “underscore EYP-1901’s potential as a paradigm-altering maintenance treatment for patients with wet AMD,” further noting that “there is potential for meaningfully lower sized and lower cost pivotal Phase 3 trials.”
The results mark EyePoint as a potential player in a competitive space. Regeneron’s Eylea has been a mainstay treatment for AMD, though this was upset earlier this year when Roche’s treatment, Vabysmo, made waves with a longer-interval treatment. By halfway through 2023, Vabysmo sales hit $1.1 billion. This came as Regeneron’s sales of Eylea slipped from $1.6 billion in the third quarter of 2022 to $1.4 billion in Q3 2023, with the company blaming “increased competition,” among other factors, for the 11% drop from last year.
Carl Regillo, chief of Retina Service at Wills Eye Hospital, said in the company’s release that the results of the Phase II trial show “essentially no difference in visual outcome at the blended six-month endpoint from a single injection of EYP-1901 compared to on-label, bimonthly aflibercept injections.” He went on to note that the “reduction in treatment burden and supplement-free rates observed, along with the consistently favorable safety profile,” suggest EYP-1901 could represent “a paradigm shift in how patients with wet AMD are treated.”