EyePoint Pharmaceuticals announced positive results from its good laboratory practice (GLP) preclinical toxicology study of EYP-1901, a potential six-month sustained delivery intravitreal anti-VEGF treatment using its proprietary bioerodible Durasert? technology for wet age-related macular degeneration (wet AMD).

Results from the study showed no EYPT-1901-related adverse ocular or systemic toxicology findings at any dose level studied in the rabbit model. There were no changes in key ocular measurements such as intraocular pressure (IOP) and no changes in liver function enzymes as is often seen with systemic delivery of tyrosine kinase inhibitors. These results provide additional rationale for the advancement of EYP-1901 into clinical development.

“We continue to believe in the potential of EYP-1901 to be a disruptive and beneficial treatment option for patients and physicians for the long-term treatment of wet AMD. These promising safety results reinforce the potential product profile of EYP-1901 and will be included in our Investigational New Drug (IND) submission that is expected to be filed before the end of the year,” said Jay Duker, M.D., Chief Strategic Scientific Officer of EyePoint Pharmaceuticals. “Upon IND allowance by the U.S. Food and Drug Administration (FDA), we plan to rapidly initiate our Phase 1 clinical trial of EYP-1901 and dose our first patient in early 2021.”

EYP-1901 is a potential six-month sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration. EYP-1901 combines EyePoint’s proprietary bioerodable Durasert? sustained release technology with vorolanib, a tyrosine kinase inhibitor. Vorolanib has established efficacy signals observed in two prior human trials in wet AMD as an orally delivered therapy with no significant ocular adverse events reported. Preclinical studies of EYP-1901 administered locally into the eye have shown promising anti-VEGF activity with no serious safety issues observed. EyePoint plans to submit an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) by the end of 2020 and expects to initiate a Phase 1 trial in early 2021. EYP-1901 is initially being developed as a treatment for wet AMD, with the potential for future indications in diabetic retinopathy and retinal vein occlusion.