NeoVista announces positive 18-month study results for brachytherapy AMD treatment

SCOTTSDALE, Ariz. — A phase 2 feasibility study evaluating a novel epiretinal brachytherapy for treating wet age-related macular degeneration showed positive 18-month safety and efficacy results, NeoVista announced in a press release.

The ongoing multicenter study enrolled 34 patients with predominantly classic, minimally classic or occult choroidal neovascularization who received a single 24 Gy treatment of NeoVista's epiretinal brachytherapy combined with two intravitreal injections of Avastin (bevacizumab, Genentech). Injections were administered either before or at the time of radiation and again 1 month thereafter, with additional therapy administered based on assessed levels of disease activity, according to the release.

The first 25 patients to reach 18-month follow-up showed a mean visual acuity improvement of 10.7 EDTRS letters and received a mean 2.4 bevacizumab injections. In addition, 96% of patients lost less than 15 letters, 44% gained 15 or more letters, and 8% improved by 30 or more letters.

A total of 68% of patients required no additional bevacizumab injections, the release said.

Most adverse events stemmed from the vitrectomy procedure and included retinal tear, retinal detachment, subretinal hemorrhage and vitreous hemorrhage.

To date, there have been no instances of radiation toxicity.

NeoVista is currently enrolling patients for its pivotal CABERNET trial, which will evaluate the safety and efficacy of the epiretinal brachytherapy administered concomitantly with Lucentis (ranibizumab, Genentech) vs. ranibizumab alone among 450 patients at 45 sites worldwide.

Study results were announced at the Retina Society scientific meeting.