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Control BCVA, best-corrected visual acuity; VA, visual acuity Data as of January 16, 2025. Preliminary data pending final analysis. MEAN CHANGE IN BCVA FROM BASELINE +10.3 +3.0 Mean Change in BCVA vs Aflibercept +6.5 DURAVYU 2.7mg +7.3 Supplement-free is defined as patients who did not receive a supplement at any point during the study. 2025 EyePoint Pharmaceuticals, Inc.
Baseline (Day 1)2 Investigator discretion Starting at Week 12 (unique supplementation criteria incorporated due to PRN design of trial): Lack of 10% reduction in CST compared to Baseline (Day 1) VERONA: Phase 2 Clinical Trial Met Primary and Key Secondary Endpoints Data supports DURAVYU as a Potential Treatment for DME with improvement in vision and anatomy with superior dosing intervals 2025 EyePoint Pharmaceuticals, Inc.
DME, diabetic macular edema; VEGF, vascular endothelial growth factor; BCVA, best corrected visual acuity; OCT, optical coherence tomography; CST, central subfield thickness DURAVYU dosing Visit Scheduled aflibercept injection Sham injection DURAVYU 1.3mg (n=10) DURAVYU 2.7mg (n=11) Aflibercept 2mg single injection (n=6) Supplemental Anti-VEGF injection based on prespecified criteria Objectives: Evaluate the safety and efficacy of DURAVYU in patients with active DME (CST >325 m) Collect dose-ranging data to inform Phase 3 clinical trials Primary endpoint: time to supplemental anti-VEGF injection up to week 24 Key Secondary endpoints: safety, change in BCVA vs. aflibercept control and anatomical control (CST) Primary endpoint -D28 to -D7 D1 W4 W8 W12 W16 W20 W24 VERONA Phase 2 Clinical Trial - Randomized, Open-Label, Aflibercept Controlled as a Potential Treatment for DME VERONA Clinical Trial Supplement Criteria 2025 EyePoint Pharmaceuticals, Inc.
Graefes Arch Clin Exp Ophthalmol. 2021;259(10):2977 2986. https://doi.org/10.1007/s00417-021-05210-3. Patients in the US with diabetes by 20301 Global branded market by 20303 Delayed/missed treatment visits4 54.9M 25% up to 51% $3.9B Develop DME within 10 years2 Vision loss from missed injection5 5-6 letters By 2050, diabetes-related vision loss is expected to cost 500 million US dollars annually6 DURAVYU is Uniquely Positioned to Provide an Improved DME Treatment Paradigm Compared to Current Anti-VEGF Therapies 2025 EyePoint Pharmaceuticals, Inc.
PubMed 2020 PMID: 32829485 DOI: 10.1111/ceo.13845. 5. Lee, R., Wong, T.Y. & Sabanayagam, C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye and Vis 2, 17 (2015). https://doi.org/10.1186/s40662-015-0026-2. 6. Nagda D, Mitchell W, Zebardast N. The functional burden of diabetic retinopathy in the United States.
Diabetes 2030: Insights from Yesterday, Today and Future Trends. PubMed Central. 2017 PMCID: PMC5278808 PMID: 27124621 . 2. Russel Lazarus. Optometrists Network. Guide to Eye Conditions; Diabetic Macular Edema. 3. DelveInsights DME Market Report -2030. 4. Monique A. Rose, Meri Vukicevic, Konstandina Koklanis. Adherence of patients with diabetic macular oedema to intravitreal injections: A systematic review.
Wet AMD, wet age-related macular degeneration; NPDR, non-proliferative diabetic retinopathy; DME, diabetic macular edema; SAEs, serious adverse events; BCVA, best-correct visual acuity; OCT, optical coherence tomography. Clinical Trial Indication Safety Key Efficacy Outcomes DAVIO wet AMD No DURAVYU related ocular or systemic SAEs Stable BCVA and CST 74% reduction in treatment burden DAVIO 2 wet AMD Statistically non-inferior BCVA vs on-label aflibercept >80% reduction in treatment burden Stable anatomy (CST) PAVIA NPDR Stable or prevention of worsening disease severity VERONA1 DME Primary endpoint met Meaningful, immediate and sustained improvement in BCVA and OCT DURAVYU Has Been Evaluated in Over 190 Patients to Date Across Multiple Indications 2024 EyePoint Pharmaceuticals, Inc.
DURAVYUTM (EYP-1901): Vorolanib in Durasert ETM Durasert E Bioerodible, sustained IVT drug delivery Vorolanib Patented and potent receptor tyrosine kinase inhibitor (TKI): selectively inhibits all VEGF signaling Endothelial cell TIE2 Blood vessel stability VEGFR1 VEGFR2 VEGFR3 VEGF Receptors Angiogenesis DURAVYU Vorolanib bound to target receptors Vorolanib Durasert E No delay reaches target tissues at therapeutic levels within hours of administration No fluctuation delivered as a continuous dose with zero-order kinetics No free-floating drug fully eluted before matrix bioerosion No cold storage shipped and stored at ambient temperature Controlled release over a period of at least 6 months 2024 EyePoint Pharmaceuticals, Inc.