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FDA Grants NeoVista's Request to Utilize Novel Wet AMD Treatment in Compassionate Case
Date:12/10/2008

NeoVista's Epiretinal Brachytherapy Granted Compassionate Use to Attempt to Prevent Complete Vision Loss in Patient

FREMONT, Calif., Dec. 10 /PRNewswire/ --NeoVista, Inc., announced today that the U.S. Food and Drug Administration (FDA) had approved the company's "compassionate case" waiver to utilize its novel wet age-related macular degeneration (AMD) treatment on a patient with an advanced form of the disease who did not meet criteria for inclusion into current NeoVista investigational treatment protocols. The patient received NeoVista's therapy today in Nashville, Tenn.; the procedure was performed by Dr. Carl Awh, President of Tennessee Retina, and an investigator in NeoVista's ongoing Phase III study, CABERNET (CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy).

The patient suffered from advanced wet AMD in both eyes and had not benefited from any available treatment, including anti­vascular endothelial growth factor (anti-VEGF) agents, the current standard of care for wet AMD. The patient's left eye had progressively worsened despite treatment with photodynamic therapy and intravitreal steroids prior to the advent of anti-VEFG therapy, as well as later injections of anti-VEGF agents. Her right eye was following a parallel course, with advanced vision loss due to an enlarging exudative retinal detachment caused by wet AMD. Because of the similarity in the appearance of the two eyes and the failure of prior therapies to successfully treat the left eye, a decision was made to treat the patient's right eye with NeoVista's therapy.

"With the FDA granting a waiver for this case, today both my patient and I had access to a promising, new therapy for the treatment of her case of severe wet AMD," said Dr. Awh. "If this approach proves effective in her case, other patients with similar types of advanced, progressive wet AMD m
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SOURCE NeoVista, Inc.
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