FDA Approves Compassionate Use of Investigational Treatment for AMD

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The FDA has given compassionate approval to use NeoVista‘s Epiretinal Brachytherapy (a procedure that is presently in Phase III studies) to treat a woman’s wet-AMD (age-related macular degeneration). The company hopes that its NeoVista Epi-Rad 90™ Ophthalmic System one day will become a therapeutic option for patients with wet-AMD. John N. Hendrick, President and CEO of NeoVista says, “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.”
From a NeoVista, Inc. press release:

The patient received NeoVista’s therapy … 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 anti-­vascular 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…
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.

To understand how the system works, please take a look at the video distributed by the company to the media: