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EyePoint Pharmaceuticals (EYPT) investor relations material
EyePoint Pharmaceuticals Stifel 2025 Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Clinical development progress
Phase III trials for wet AMD (LUGANO and LUCIA) are fully enrolled, with top-line data expected mid-2026 and a second trial to follow soon after.
DME phase III trials (COMO and CAPRI) will begin dosing in Q1 2026, randomizing 240 patients each, with top-line readouts anticipated in Q4 2027.
Four prior trials (one phase I, three phase II) showed strong efficacy and safety in over 190 patients, with no ocular or systemic SAEs.
DuraCert/Durasert E technology is proven, with four FDA-approved products and controlled, sustained drug delivery.
Pipeline includes preclinical asset EYP2301 (ResprotaFib), a TIE-2 agonist for retinal diseases, with Phase 3 FPI anticipated in Q1 2026.
Technology and mechanism of action
Duravyu, a DuraCert E product, delivers 94% drug and 6% matrix, with no PLGA or PEG, and provides sustained release for at least six months.
Vorolanib, the active drug, blocks all VEGF receptors and inflammation via JAK1, offering multi-MOA benefits including anti-VEGF, anti-PDGF, and anti-IL-6 effects.
Immediate drug levels are achieved in the choroid, and the insert dissolves without leaving free-floating particles.
The injector system is preloaded, sterile, and can be stored at room temperature, reducing logistical burdens.
DURAVYU is the only TKI in development for DME, with a dual mechanism targeting both VEGF and IL-6.
Clinical trial design and results
Wet AMD phase III trials are non-inferiority studies using on-label Eylea as control, with all patients loaded with Eylea monthly.
DME phase II Verona trial showed Duravyu provided faster and greater vision improvement and OCT reduction compared to Eylea, attributed to IL-6 blockade.
Over 70% of patients in the 2.7 mg arm were rescue-free, with significant anatomical normalization and sustained effects for 24 weeks after a single dose.
Dose-dependent reduction in macular leakage and improved BCVA were observed, with comparable efficacy to monthly anti-VEGF plus anti-IL-6 regimens but with fewer injections.
Rescue criteria in wet AMD phase III is loss of five letters from best on study with 75 microns of new fluid.
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