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Use of novel wet age-related macular degeneration treatment given nod by FDA According to a report coming from NeoVista, Inc., the FDA has approved its “compassionate case” waiver for utilizing its novel wet age-related macular degeneration (AMD) treatment on a patient with an advanced form of this disease.

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).

From News-Medical.Net:

The patient suffered from advanced wet AMD in both eyes and had not benefited from any available treatment, including antiÂvascular 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 may 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.

Dr. Awh remarked that both he and his patient would now be accessible to a promising and new therapy for treating the case of severe wet AMD.

John N. Hendrick, President and CEO of NeoVista, said that it is extremely pleasing to note that the FDA has granted its approval to allow the use of a compassionate use waiver in this circumstance.

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