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FDA Grants NeoVista's Request to Expand CABERNET Trial to 30 Sites in the U.S.
Date:4/17/2008

ERNET trial are 1) the noninferiority of epiretinal brachytherapy plus Lucentis versus Lucentis alone based on the proportion of subjects losing fewer than 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 12 months as compared to baseline or 2) the superiority of epiretinal brachytherapy plus Lucentis versus Lucentis alone based on the proportion of subjects gaining 15 letters or more on the ETDRS chart at 12 months.

In contrast to previous forms of radiation therapy for wet AMD, NeoVista's therapy delivers a one-time peak dose of beta particle energy (24 Gy) directly to the lesion, and the normal retinal vasculature receives minimal exposure. Utilizing strontium 90, the focused energy is delivered to a target area up to 3 mm in depth and up to 5.4 mm in diameter; the radiation exposure within the ocular compartment is below the clinical threshold of observable tissue damage for all structures including the lens, optic disc, and retina. Importantly for patients, the systemic exposure to radiation is minimal, as the effective dose to the entire body from NeoVista's epiretinal device is less than that from a typical chest x-ray.

Prior to the CABERNET trial, the company had conducted a feasibility trial to test the efficacy and safety of their brachytherapy device when used concomitantly with two intravitreal injections of Avastin(R) (bevacizumab), which yielded promising results after 12 months. At the 1 year follow-up evaluation of 33 participants, subjects had experienced a mean improvement in best-corrected visual acuity of 10 letters from baseline using the ETDRS chart.

About NeoVista, Inc.

NeoVista, Inc. is a privately held development-stage medical device company based in Fremont, California. NeoVista's epiretinal brachytherapy is currently being studied in a definitive Phase III clinical study to support eventual filing for regulatory approval to market the product in the United States. NeoVista recently
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SOURCE NeoVista, Inc.
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