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EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT) shared details on Tuesday about its pivotal Phase 3 program of Duravyu (vorolanib intravitreal insert) for diabetic macular edema (DME) and began first patient dosing, anticipated in the first quarter of 2026.
DME is the leading cause of vision loss in type 1 and type 2 diabetes patients. Damaged blood vessels leak fluid into the macula, the central portion of the retina responsible for sharp vision needed for routine tasks such as driving or reading.
Phase 3 Clinical Program Overview
The U.S. Food and Drug Administration (FDA) alignment on the approval pathway in DME consists of two identical non-inferiority trials (“COMO” and “CAPRI”). The trials will include redosing of Duravyu every six months.
Each trial will enroll approximately 240 patients, including those previously treated and those who are treatment naïve, randomly assigned to either a Duravyu 2.7mg arm or an on-label 2mg aflibercept control arm. Randomization occurs on Day 1.
The primary endpoint is the change from baseline in best-corrected visual acuity (BCVA) at weeks 52 and 56, compared to on-label 2mg Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) Eylea (aflibercept).
Also Read: 4D Molecular Therapeutics Rallies On Heels Of Diabetes-Related Vision Study
The company also shared new preclinical data that demonstrates vorolanib inhibits interleukin-6 (IL-6) mediated inflammation through inhibition of all Janus Kinase (JAK) receptors in addition to known blockage of vascular endothelial growth factor (VEGF) mediated vascular permeability.
IL-6 is a pro-inflammatory cytokine that is observed at significantly higher levels in patients with DME and wet AMD compared to healthy individuals.
IL-6 signaling occurs via activation of the JAK kinases, particularly JAK-1, leading to vascular leakage and inflammation that together compound damage to the blood-retinal barrier in DME.
The company will present the preclinical data on JAK/IL-6 inhibition at the Eyecelerator meeting at AAO 2025.
On Tuesday, EyePoint Pharmaceuticals priced its public offering of 11 million shares at $12/share, pre-funded warrants to purchase up to 1.5 million shares at $11.999/pre-funded warrant, for approximately $150 million in gross proceeds.
EyePoint will use the proceeds to advance clinical development of Duravyu for wet age-related macular degeneration (wet AMD) and DME, support its earlier-stage pipeline development initiatives, and for general corporate purposes.
Price Action: EYPT stock is down 1.98% at $12.90 at the last check on Wednesday.
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