EyePoint Pharmaceuticals has dosed the first subject in the Phase II DAVIO 2 clinical trial of EYP-1901, for treating wet age-related macular degeneration (wet AMD).

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.