NeoVista epimacular brachytherapy system in UK clinical trial

Fremont, CA

-NeoVista Inc.’s new epimacular brachytherapy system (Vidion Anti-Neovascular Surgical System) for the treatment of age-related macular degeneration (AMD) is now available in the United Kingdom (UK).

The new surgical device, developed by NeoVista and distributed in the UK by Carleton Ltd., recently received a CE mark certifying that it has met the European Union’s medical device directive.

The system is being introduced in 15 hospitals across the UK as part of the MERLOT clinical trial, where it will be used in patients whose current standard-of-care treatment involves regular injections of a drug into the eye to control their condition (up to one injection every month, indefinitely). Although the treatment is available only at select hospitals, the company anticipates that the number of sites using the device will increase quickly, providing nationwide availability.

“This is a relatively straightforward operation, and the published results are very impressive,” said Tim Jackson, PhD, FRCOphth, a consultant eye surgeon at King’s College Hospital, London, who is the lead investigator for MERLOT. “My experience in our own trials of this device has also been encouraging, and it is a big step forward to be able to offer patients this new treatment throughout the UK within a large, randomized, controlled clinical trial.”

The epimacular brachytherapy device delivers the peak dose of strontium-90 beta-ionizing radiation directly to the lesion in an effort to minimize exposure to the surrounding tissue. The device includes a delivery tip similar in size to a needle, and the effective dose of radiation to a patient’s entire body is less then that experienced with a routine chest radiograph, according to the company.

“To date, over 400 patients have been treated safely with epimacular brachytherapy in our comprehensive clinical program,” said John N. Hendrick, president and chief executive officer of NeoVista. “We are looking forward to bringing [the device] to millions of European patients with wet AMD who are seeking a more cost-efficient option that we expect will be as effective, if not better, than the current standard of care.”