EyePoint Pharmaceuticals Reports Positive Interim Safety and Efficacy Data from Phase 1 DAVIO Clinical Trial Evaluating EYP-1901 for the Treatment of Wet AMD
EyePoint Pharmaceuticals announced 6-month interim data from the “Durasert and Vorolanib in Ophthalmology” (DAVIO) phase 1 clinical trial of EYP-1901, a bioerodible sustained delivery intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment targeting wet age-related macular degeneration (AMD). The data are being presented today at the American Academy of Ophthalmology (AAO) 2021 Annual Meeting Retina Subspecialty Day in New Orleans by David S. Boyer, MD, Senior Partner at Retina-Vitreous Associates Medical Group and adjunct clinical professor of Ophthalmology with the University of Southern California/Keck School of Medicine.
“We are very encouraged by these data that reinforce EYP-1901’s positive safety profile and its durable anti-VEGF activity up to six months so far in the majority of enrolled patients after a single intravitreal injection,” Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals, said in a company news release. “Wet AMD is a leading cause of blindness, and these data bring us one step closer to potentially changing the standard of care for patients by offering an in-office sustained delivery treatment option with the potential for up to every six-month dosing.”
The phase 1 DAVIO clinical trial is an open-label, dose escalation clinical trial of EYP-1901 that enrolled 17 patients with previously treated wet AMD. EYP-1901 is a sustained delivery anti-VEGF (voralanib) investigational treatment that utilizes a bioerodible formulation of EyePoint’s Durasertdrug delivery technology that has been utilized in four FDA-approved products, including EyePoint’s Yutiq for chronic noninfectious uveitis affecting the posterior segment of the eye.
Six-month interim data from the phase 1 DAVIO clinical trial show no reports of ocular SAEs or drug-related systemic SAEs. Further, there were no reported adverse events such as vitreous floaters, endophthalmitis, retinal detachment, implant migration in the anterior chamber, retinal vasculitis, or posterior segment inflammation. These data showed 76% and 53% of patients did not require rescue following a single dose of EYP-1901 up to four and six months, stable and sustained BCVA (-2.5 letters) and CST (-2.7 μm), a 79% reduction in treatment burden at six months, and a median time to rescue of six months across all patients.
“We are grateful to the patients, investigators, and site staff who are participating in the DAVIO phase 1 trial. We are very encouraged by today’s data results, which demonstrated the safety and sustained anti-VEGF activity of EYP-1901 in wet AMD patients,” said Dr. Boyer, a member of EyePoint’s Scientific Advisory Board and a DAVIO Clinical Investigator. “Seeing treatment improvements for these patients is very promising, and we look forward to starting the next phase of this development program next year.”
"Our clinical trial includes patients with previously treated wet AMD, who received frequent anti-VEGF injections prior to entering DAVIO. We were thrilled to see how well tolerated the EYP-1901 inserts appear to be and how well patients responded to EYP-1901 for both vision and anatomical endpoints over the six-month interim report of this 12-month study. These results are not only promising as we plan to move EYP-1901 into phase 2 in wet AMD, but also for the potential to change the treatment paradigm for many wet AMD patients," said Jay S. Duker, MD, Chief Operating Officer of EyePoint Pharmaceuticals. "We are encouraged by responses to date and will continue to monitor the progress of these patients as they complete the second half of this trial.”
EyePoint plans to initiate a phase 2 wet AMD clinical trial in 2022 and the company has scheduled a Type C meeting with the FDA on December 1, 2021, to discuss specific plans and obtain guidance on potential EYP-1901 registration trials. The company also expects to initiate additional EYP-1901 clinical trials in diabetic retinopathy (DR) and retinal vein occlusion (RVO).