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

ay also benefit under compassionate use waivers from the FDA."

NeoVista's novel therapy applies a targeted dose of beta radiation to the abnormal leaking blood vessels that affect central vision in patients with wet AMD. Preliminary data show that NeoVista's targeted radiation therapy can be safe for both the patient and the physician, and may be able to improve patient's vision. The current standard of care for wet AMD requires monthly injections of anti-VEGF drugs into the eye for an indefinite period of time.

In contrast to other forms of radiation therapy for wet AMD, NeoVista's approach delivers the peak dose of energy directly to the lesion without damaging the normal retinal vasculature. 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. 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.

"We're extremely pleased that the FDA has granted us a compassionate use waiver in this circumstance," said John N. Hendrick, President and CEO of NeoVista. "Even though this patient has not benefited from currently approved therapies, our hope is that she will benefit from our treatment as a final effort to avoid complete loss of vision."

The purpose of the compassionate use waiver is to offer a limited number of patients with serious conditions and no other alternatives the opportunity to potentially benefit from an investigational treatment that has not yet been approved for use by the FDA. While receiving the compassionate use approval for this patient, NeoVista continues to enroll patients in the company's pivotal trial, CABERNET.

CABERNET is a multicenter, randomized, controlled study that will enroll 450 subjects at 45 sites worldwide, evaluating the
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SOURCE NeoVista, Inc.
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