Oraya Therapeutics Gets Added CE Mark Indication for IRay System

Newark, Calif. devicemaker Oraya Therapeutics received a CE mark extension for its IRay Radiotherapy system for treatment of choroidal metastases, the firm said Tuesday. The new indication expands on the 2010 CE Mark the system received to treat age-related macular degeneration.

Choroidal metastases are quick-growing eye tumors that need prompt treatment to prevent vision loss, Oraya said. While chemotherapy is an option, radiation therapy is typically the preferred treatment using either plaque brachytherapy or external beam radiation therapy. These invasive procedures require therapy regimens that can take days or weeks to complete, according to the company.

Using the IRay system, a robotically positioned, low-energy X-ray source delivers a precise dose of radiation to the back of the eye in a 15 to 20 minute noninvasive procedure, reducing the need for multiple treatments, Oraya said.

The system will be available to patients in the UK, Germany and Switzerland. — Kellen Owings