EyePoint Pharmaceuticals has initiated the Phase II VERONA clinical trial of EYP-1901, a potential treatment for diabetic macular oedema (DME).
The first patient has received a dose in the study, which is evaluating the therapy in people who have undergone standard anti-vascular endothelial growth factor (VEGF) therapy earlier.
VERONA is a three-arm, controlled, randomised, single-masked trial that will enrol nearly 25 patients.
Participants will be assigned to receive one of two intravitreal doses of EYP-1901 or an aflibercept control.
The trial’s primary efficacy goal is to assess the time to the first supplemental aflibercept injection up to 24 weeks, based on pre-defined criteria.
Evaluating safety, changes in best corrected visual acuity (BCVA), central subfield thickness (CST) and the diabetic retinopathy severity scale (DRSS) will comprise secondary objectives.
These endpoints aim to establish the potential of EYP-1901 as a transformative treatment for VEGF-mediated retinal diseases.
An investigational sustained delivery therapy, EYP-1901 comprises vorolanib, a selective tyrosine kinase inhibitor, formulated in bioerodible Durasert E.
EYP-1901 utilises Durasert E technology of EyePoint to deliver vorolanib.
The optimism surrounding EYP-1901 is boosted by positive outcomes from the Phase I DAVIO and Phase II DAVIO 2 trials in wet age-related macular degeneration (AMD).
The trials demonstrated promising efficacy and safety profiles of the therapy.
In addition to DME, EYP-1901 is also under investigation for non-proliferative diabetic retinopathy, expanding its potential impact within retinal disease treatment.
EyePoint Pharmaceuticals CEO Jay Duker said: “There is a significant need for differentiated and longer-acting treatments for DME patients, as the current standard of care requires frequent intravitreal injections that are burdensome and can result in under-treatment.
“We are encouraged by the growing body of clinical data for EYP-1901 and we are optimistic that EYP-1901 has the potential to change the current treatment paradigm for DME with topline data expected in Q1 2025.”
