NeoVista receives FDA approval to expand brachytherapy AMD trial to 30 sites in United States

FREMONT, Calif. — NeoVista has received approval from the U.S. Food and Drug Administration to expand the number of sites participating in its CABERNET trial from 10 to 30 in the United States, the company announced in a press release. The trial's expansion was dependent on the FDA's approval of 90-day safety data, the release said.

The pivotal phase 3 study is expected to enroll a total of 450 patients with wet age-related macular degeneration to evaluate the safety and efficacy of NeoVista's novel epiretinal beta radiation therapy delivered in conjunction with a limited vitrectomy and concomitant with two intravitreal injections of Lucentis (ranibizumab, Genentech) against ranibizumab alone.

Patients enrolled in the trial arm utilizing brachytherapy will receive ranibizumab injections at the time of surgery and at 30 days postoperatively. The primary endpoints in the trial are the noninferiority of epiretinal brachytherapy plus ranibizumab vs. ranibizumab alone based on the proportion of subjects losing fewer than 15 ETDRS letters at 12 months, and the superiority of epiretinal brachytherapy plus ranibizumab vs. ranibizumab alone based on the proportion of subjects gaining 15 ETDRS letters at 12 months.

NeoVista's therapy utilizes strontium 90 to deliver a single peak dose of 24 Gy of beta particle energy directly to a target area of up to 3 mm deep and up to 5.4 mm in diameter, with minimal radiation exposure to the normal retinal vasculature and ocular compartment, the release said.

Prior to the CABERNET trial, NeoVista conducted a feasibility study to assess the safety and efficacy of its brachytherapy device when used concomitantly with two intravitreal injections of Avastin (bevacizumab, Genentech). At 1-year follow-up, 33 patients had experienced a mean improvement in best corrected visual acuity of 10 ETDRS letters, according to the release.