March 31, 2008
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NeoVista reports promising 1-year study results for its brachytherapy AMD treatment

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PALM BEACH, Fla. — A feasibility study evaluating NeoVista's novel epiretinal brachytherapy as a treatment for wet age-related macular degeneration shows positive 1-year results, according to a press release from the company.

In the ongoing, nonrandomized, multicenter study, 34 patients with predominantly classic, minimally classic or occult choroidal neovascularization received a single 24 Gy treatment with NeoVista's epiretinal brachytherapy in conjunction with two injections of Avastin (bevacizumab, Genentech). These injections were administered either before or at the time of radiation and again at 1 month after treatment, the release said.

NeoVista announced the results at the Annual Macula Society Meeting.

At 1 year follow-up of 33 patients, visual acuity had improved by 10 ETDRS letters. Also, 94% of all patients lost less than 15 letters, 39% improved by 15 or more letters and 12% gained 30 or more letters, according to the release.

Overall, 76% of patients required no additional bevacizumab injections, the release noted.

Most adverse events were related to the vitrectomy procedure and included retinal tear, retinal detachment, subretinal hemorrhage and vitreous hemorrhage. No adverse events related to radiation toxicity have been reported, the release said.

A planned phase 3 study - called the CABERNET trial - will enroll 450 patients at clinical centers worldwide to assess the safety and efficacy of NeoVista's epiretinal beta radiation therapy administered in conjunction with Lucentis (ranibizumab, Genentech) vs. ranibizumab alone, according to the release.