EyePoint Pharmaceuticals announced that the first patient has been dosed in the Phase 1 clinical trial of EYP-1901 as a potential twice-yearly sustained delivery anti-VEGF treatment targeting wet age-related macular degeneration (wet AMD).

EYP-1901 leverages the Company’s proprietary Durasert? drug delivery technology that has been used in four FDA-approved products, including EyePoint’s YUTIQ? for chronic non-infectious uveitis affecting the posterior segment of the eye. EYP-1901 uses a bioerodible Durasert formulation combined with a clinically validated anti-VEGF molecule, vorolanib. In oral formulation, vorolanib demonstrated efficacy and ocular safety through Phase 2 trials in wet AMD. In addition to wet AMD, EYP-1901 is anticipated to be studied for the potential treatment of diabetic retinopathy and retinal vein occlusion in future clinical trials.

The Phase 1 DAVIO open-label, dose escalation trial, will examine thirteen wet AMD patients who were responsive to previous anti-VEGF treatments. EYP-1901 will be delivered via a single intravitreal injection in the physician's office. The primary endpoint of the trial is safety, and key secondary endpoints are best-corrected visual acuity (BCVA) and central subfield thickness. Based on clinical outcomes during the initial dose escalation phase, there is a potential to expand the trial.

“We believe EYP-1901 represents a promising new approach for treating wet AMD, a disease that despite the availability of current anti-VEGF therapies continues to progressively impair vision in millions of patients,” said Nancy Lurker, President and Chief Executive Officer, EyePoint Pharmaceuticals. “Current approved treatments are effective, but they require monthly or bi-monthly eye injections in a physician’s office, which can cause inconvenience and discomfort and often lead to reduced compliance and poor outcomes. The sustained release, intravitreal anti-VEGF formulation of EYP-1901 has the potential to become the first treatment for wet AMD with twice yearly dosing, representing a significant market opportunity for EyePoint.”

“The potential efficacy of vorolanib coupled with the well-characterized safety and predictable drug release kinetics of the Durasert delivery technology offer the potential to provide millions of wet AMD sufferers a convenient and effective treatment option, if approved,” said Jay S. Duker, M.D., Chief Strategic Scientific Officer, EyePoint Pharmaceuticals and Chair of Ophthalmology at Tufts Medical Center and Tufts University School of Medicine. “We are excited to have this trial underway and are looking forward to seeing initial data as early as the second half of this year.”

EYP-1901 is a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration. EYP-1901 combines a bioerodible formulation of EyePoint’s proprietary Durasert? sustained release technology with vorolanib, a tyrosine kinase inhibitor. Vorolanib provided clear efficacy signals in two prior human trials in wet AMD as an orally delivered therapy with no significant ocular adverse events. Preclinical studies of EYP-1901 have shown anti-VEGF activity in disease models of ocular neovascularization and no serious safety issues were observed. EYP-1901 is initially being developed as a treatment of wet AMD, with the potential for additional indications in diabetic retinopathy and retinal vein occlusion.