The randomised, controlled, 12-month trial intends to enrol nearly 150 subjects who have received a standard-of-care anti-vascular endothelial growth factor (anti-VEGF) therapy earlier.
These subjects will be randomised to receive one of two doses of EYP-1901 (2mg or 3mg) or an aflibercept control.
Variation in best corrected visual acuity (BCVA) versus aflibercept control six months following dosing with EYP-1901 is the trial’s primary efficacy endpoint.
Change in central subfield thickness (CST) as evaluated by optical coherence tomography (OCT), time to first supplemental anti-VEGF and safety are included as secondary efficacy endpoints.
EYP-1901 is an investigational sustained delivery anti-VEGF therapy.
It merges a bioerodible formulation of Durasert delivery technology of the company with a tyrosine kinase inhibitor, vorolanib.
The therapy is administered through a single intravitreal injection.
The company anticipates preliminary topline findings from the trial in the second half of next year.
EyePoint Pharmaceuticals CEO Nancy Lurker said: “Using a ‘Treat to Maintain’ therapeutic approach, EYP-1901 has the potential to transform the wet AMD treatment landscape by sustaining a majority of patients up to six months without supplemental anti-VEGF treatment, thereby greatly reducing the treatment burden.
“We are encouraged by the safety and efficacy results from our Phase I DAVIO trial, including no reports of ocular or drug-related systemic serious adverse events and strong durability data with 53% of patients requiring no supplemental treatment up to six months.”
Last month, the company reported positive data from the Phase I DAVIO trial of EYP-1901 for wet AMD.