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August 2, 2022

EyePoint doses first subject in Phase II wet AMD therapy trial

The company anticipates preliminary topline findings from the trial in the second half of next year.

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.

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