Compassionate use of radiation treatment for AMD approved

December 17, 2008

NeoVista's epiretinal brachytherapy has been granted a compassionate waiver by the FDA to treat advanced wet age-related macular degeneration (AMD) in a patient who was not eligible for inclusion in NeoVista's current trials of the product.

NeoVista's epiretinal brachytherapy has been granted a compassionate waiver by the FDA to treat advanced wet age-related macular degeneration (AMD) in a patient who was not eligible for inclusion in NeoVista's current trials of the product.

The patient - who was treated by Dr Carl Awh, an investigator in the Phase III CABERNET trial - had been unresponsive to standard AMD treatments, including photodynamic therapy, intravitreal steroids and anti-VEGF therapy, and was at risk of total vision loss from bilateral advanced wet AMD.

Epiretinal brachytherapy, a radiation therapy, delivers a targeted dose of strontium 90 directly to lesions up to 3 mm deep and 5.4 mm wide. NeoVista's Phase II trial, evaluating brachytherapy in combination with Avastin (bevacizumab), demonstrated an improvement in mean VA in subjects using brachytherapy plus Avastin; adverse events in the Phase II trial were limited to vitrectomy-related problems and not to radiation toxicity. The ongoing Phase III trial is investigating the safety and efficacy of NeoVista's epiretinal brachytherapy with Lucentis (ranibizumab; Novartis) versus Lucentis alone.

The success of using brachytherapy in this particular compassionate case has not yet been determined.