Port Delivery System Under Priority Review by FDA

Frequent Eye Injections May Soon Be History

Genentech Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) is giving priority review for the company’s Port Delivery System for the treatment of wet age-related macular degeneration (AMD). If approved, PDS will be a first-of-its-kind therapeutic approach, offering people living with wet AMD an alternative to frequent eye injections. The FDA is expected to make a decision on approval by Oct. 23, 2021.

As reported here earlier, PDS is a permanent refillable eye implant, approximately the size of a grain of rice, designed to continuously deliver a customized formulation of Lucentis over a period of up to six months with no reduction in safety or efficacy.

Genentech has a robust Phase III clinical development program underway for PDS, including the Portal, Pagoda and Pavilion studies. Portal is an extension study evaluating the long-term safety and efficacy of PDS in wet AMD. Pagoda is evaluating PDS for the treatment of diabetic macular edema (DME), while Pavilion is a study of PDS in diabetic retinopathy without DME. Both the Pagoda and Pavilion trials are actively recruiting participants.

SOURCE: Genentech Press Release