A Medical Device Daily

NeoVista (Fremont, California) said that the FDA has granted the company's request to expand the number of sites participating in its pivotal Phase III trial from 10 to 30 in the U.S.

The approved expansion of the CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy) trial, which seeks to evaluate the safety and efficacy of the company's epiretinal brachytherapy for the wet form of age-related macular degeneration (AMD), was dependent on the FDA's review of 90-day safety data, typical of new-to-market medical devices.

The study will evaluate the safety and efficacy of NeoVista's epiretinal brachytherapy, delivered using a limited vitrectomy, concomitant with two intravitreal injections of the FDA-approved antiangiogenic therapy Lucentis (ranibizumab) versus Lucentis alone.

"With this expansion to 30 sites, we will not only be able to recruit more patients at a higher rate, taking us one step closer to commercialization in the U.S., but it will also allow additional retina specialists to see the benefits of our novel therapy first-hand while treating their patients," said John Hendrick, president/CEO of NeoVista.

"It's an exciting time at NeoVista with our recent CE-mark approval in the EU and the FDA approval of our trial expansion," he said. "We are getting closer and closer to seeing our investigational therapy become an approved treatment option for millions of patients worldwide afflicted with wet AMD."