FDA accepts Roche's 6-month Lucentis implant for priority review

The FDA is set to make a decision on whether to approve PDS by Oct. 23 (Unsplash)

The FDA has accepted Roche’s Port Delivery System with ranibizumab (PDS) for priority review. Roche is seeking approval for the drug delivery implant to free patients with wet age-related macular degeneration from the need to undergo frequent eye injections.

Roche set the stage for the FDA submission last year by showing 98.4% of patients who received PDS went six months without needing additional therapy. Over that time, the vision of the recipients of PDS improved by a comparable level to peers who received injections of ranibizumab, the active ingredient in Roche’s Lucentis.

The study suggested PDS, a permanent, refillable eye implant the size of a grain of rice, can replace drugs such as Lucentis by continuously delivering a customized formulation of the anti-VEGF therapy ranibizumab.

“Anti-VEGF therapy brings significant benefit to people with wet AMD, but optimal results require frequent trips to the doctor’s office for eye injections. This burden leaves many people under-treated and susceptible to vision loss,” Levi Garraway, chief medical officer at Roche, said in a statement.

Garraway and his colleagues are betting PDS can lift that burden, thereby improving the lives of wet AMD patients and extracting additional sales from the Lucentis active ingredient. Lucentis generated blockbuster sales last year but imminent biosimilar competition in the U.S. threatens to eat away at revenues.

PDS could cannibalize some of the Lucentis sales, enabling Roche to keep hold of part of the wet AMD market. Having shown safety and efficacy in wet AMD, Roche is now working to validate PDS in trials of patients with diabetic macular edema (DME) and diabetic retinopathy without DME.

The FDA is set to make a decision on whether to approve PDS by Oct. 23. Roche is also working to win approval in the European Union, where the medicines agency has validated the application.