EyePoint Pharmaceuticals, Inc. is a biopharmaceutical company, which engages in the development and commercialization of therapeutics that treat eye disorders. It offers FDA-approved sustained-release treatments in ophthalmology under the DEXYCU, ILUVIEN, Verisome, Retisert, and Durasert brands. The company was founded in 1987 and is headquartered in Watertown, MA.
Clinical Trials
19
4 active
Approvals
2
Total approvals
Agencies
1
Regulatory bodies
Founded
1987
Active, not recruiting
4
21.1%
Completed
10
52.6%
Recruiting
1
5.3%
Terminated
2
10.5%
Withdrawn
2
10.5%
- EyePoint Pharmaceuticals is refining its Phase 3 clinical trial design to emphasize treatment durability, a key differentiator in the competitive retinal disease market. - The revised trial structure aims to demonstrate extended duration of effect, potentially reducing treatment burden for patients with chronic retinal conditions. - A stronger durability profile could enhance the commercial positioning of EyePoint's sustained-release ocular therapy relative to existing treatment options. - The strategic trial design reflects growing industry emphasis on long-acting formulations that address unmet needs in patient compliance and real-world outcomes.
- Duravyu intravitreal insert demonstrated noninferior visual acuity outcomes compared to aflibercept 2 mg control group over 2 years in the phase 2 DAVIO 2 trial. - The sustained-release device provided stable retinal morphology and worked effectively at stabilizing disease when administered after aflibercept initiation therapy. - Ixo-vec gene therapy showed excellent safety signals throughout a 4-year study period in the phase 2 LUNA trial for neovascular AMD. - The gene therapy demonstrated excellent visual acuity stability over the extended follow-up period without significant inflammation or retinal pigment epithelium damage.
- Tyrosine kinase inhibitors EYP-1901 and OTX-TKI have demonstrated preliminary results similar to aflibercept 2 mg in treating wet age-related macular degeneration. - Multiple gene therapy programs including ABBV-RGX-314, 4D-150, and ADVM-022 are currently under investigation for neovascular AMD treatment. - Vorolanib is designed for 6-month dosing intervals, potentially reducing treatment burden for wet AMD patients. - Experts anticipate numerous clinical readouts in the next year or two that could expand treatment options for neovascular AMD patients.
- EyePoint Pharmaceuticals announced a $150 million public offering to fund clinical development of DURAVYU for wet age-related macular degeneration and diabetic macular edema. - DURAVYU combines vorolanib, a selective tyrosine kinase inhibitor, with the company's bioerodible Durasert E technology for sustained delivery treatment. - The investigational therapy is currently in Phase 3 pivotal trials for wet AMD with data expected in mid-2026, while Phase 3 trials for diabetic macular edema are planned to begin in Q1 2026. - The funding will also support earlier-stage pipeline development and general corporate purposes as the company advances its retinal disease portfolio.
- Phase 2 DAVIO-2 trial demonstrates EYP-1901's non-inferiority to aflibercept in wet AMD patients, with 50% of participants requiring no supplemental injections and an 80% reduction in treatment burden. - Interim results from VERONA DME trial reveal EYP-1901 high-dose patients gained 6 letters over aflibercept alone, showing immediate therapeutic effect and reduced need for supplemental injections. - Phase 3 LUGANO and LUCIA trials for wet AMD are progressing ahead of schedule, with LUGANO already enrolling over one-third of targeted patients.
- EyePoint Pharmaceuticals' DURAVYU demonstrated significant extension in time to first supplemental injection compared to aflibercept in Phase 2 VERONA trial. - The investigational sustained delivery therapy showed early and sustained vision improvements with strong safety profile, reporting no treatment-related serious adverse events. - The positive trial results drove EyePoint Pharmaceuticals' stock up by 3.66%, reaching $7.90 during Monday trading.
- DURAVYU 2.7mg demonstrated significant vision improvement with +7.1 letter gain and 76-micron reduction in retinal thickness at 24 weeks in diabetic macular edema patients. - The trial met its primary endpoint with 73% of patients remaining supplement-free at 24 weeks, showing a two-thirds reduction in treatment burden compared to standard care. - Phase 3 pivotal trials are planned for late 2025, following positive safety data showing no DURAVYU-related serious adverse events.
- EyePoint Pharmaceuticals' DURAVYU Phase 3 trials for wet AMD are progressing faster than expected, with the LUGANO trial one-third enrolled and LUCIA ahead of schedule. - Full data from the Phase 2 VERONA trial of DURAVYU in diabetic macular edema (DME) is anticipated in the first quarter of 2025. - EyePoint has appointed retina specialist Dr. Reginald J. Sanders to its Board and anticipates topline DURAVYU Phase 3 wet AMD data in 2026. - With approximately $370 million in cash, EyePoint's financial runway extends into 2027, supporting DURAVYU's clinical development and potential regulatory submissions.
- EyePoint Pharmaceuticals has dosed the first patient in the LUCIA trial, a Phase 3 study evaluating DURAVYU for wet age-related macular degeneration (AMD). - DURAVYU, a sustained-release therapy delivering vorolanib, aims to reduce the treatment burden associated with frequent intravitreal injections. - The LUCIA trial, along with the LUGANO trial, will assess the efficacy, safety, and dosing flexibility of DURAVYU with re-dosing every six months. - Topline data from the Phase 3 program is expected in 2026, potentially offering a new treatment paradigm for wet AMD patients.
- EyePoint Pharmaceuticals' Duravyu demonstrated significant improvement in visual acuity and retinal thickness in patients with diabetic macular edema (DME). - The Phase 2 VERONA trial showed Duravyu 2.7mg led to an 8.9-letter improvement in BCVA compared to a 3.2-letter improvement with aflibercept at 16 weeks. - Duravyu exhibited a favorable safety profile with no Duravyu-related serious adverse events and a reduced need for supplemental aflibercept injections. - These results support Duravyu's potential as a sustained-release therapy for DME, offering a less burdensome treatment option for patients.
