EyePoint Pharmaceuticals has reported positive 12-month findings from the Phase I durasert and vorolanib in ophthalmology (DAVIO) clinical trial of EYP-1901 for wet age-related macular degeneration (wet AMD) as a potential every six-month therapy.
EYP-1901 is a sustained delivery anti-vascular endothelial growth factor (anti-VEGF) therapy.
It is being developed as an investigational therapy in the initial stage for wet AMD.
It combines a bioerodible formulation of durasert delivery technology of EyePoint with an inhibitor of tyrosine kinase, vorolanib.
EyePoint obtained an exclusive licence for vorolanib from Equinox Sciences for the localised therapy of all ophthalmic ailments.
According to the 12-month safety and efficacy results from the Phase I trial of EYP-1901, no cases of ocular or treatment-associated systemic serious adverse events were observed.
Furthermore, no dose-limiting toxicities were observed with stable visual acuity and optical coherence tomography (OCT).
In the trial, 53% of eyes did not need additional anti-VEGF injections up to six months after receiving one dose of EYP-1901.
No events of endophthalmitis, retinal vasculitis, vitreous floaters, retinal detachment, implant migration in the anterior chamber, posterior segment inflammation or retinal vascular occlusive events were reported.
A continued positive 74% decline in treatment burden was seen at 12 months compared to 79% at six months.
A Phase II DAVIO2 trial for wet AMD is anticipated in the third quarter of this year while Phase II trials are expected for non-proliferative diabetic retinopathy and diabetic macular oedema in the second half of this year and next year, respectively.
EyePoint Scientific Advisory Board member Rishi Singh said: “The final 12-month results from the DAVIO clinical trial highlight EYP-1901’s continued positive safety and efficacy profile with promising durability as a potential every six-month maintenance therapy for previously treated wet AMD.
“We are grateful to the patients, investigators and site staff who participated in the Phase I DAVIO trial.”