AMD radiation therapy trial meets endpoint

Newark, CA-The INTREPID clinical trial of a proprietary radiation therapy (IRay, Oraya Therapeutics) has met its primary endpoint of reduction in anti-vascular endothelial growth factor (VEGF) injections for patients with neovascular (wet) age-related macular degeneration (AMD), according to the company.

The sham-controlled double-masked trial was designed to evaluate the effectiveness and safety of a one-time radiation therapy in conjunction with as-needed anti-VEGF injections for the treatment of wet AMD. Enrolled were 230 patients who previously had received at least three anti-VEGF injections in the previous year and required further anti-VEGF treatment.

Within 2 weeks after injection, one-third of the study participants received a sham exposure, and the remainder received a radiation dose of either 16 or 24 Gy. They were then followed monthly and treated with ranibizumab as needed according to specified re-injection criteria.

The therapy uses low-energy, highly targeted x-rays to treat wet AMD. Total procedure time typically is less than 20 minutes. Preliminary result analyses found no indication of radiation-related adverse events at the 1-year trial endpoint, according to the company.

The multinational study included sites in Austria, Czech Republic, Germany, Italy, and the United Kingdom.

“Our intent is to focus our early commercial efforts in the countries that were part of the trial, and we expect that the first participating sites will initiate treatments within the next few months,” said Jim Taylor, chief executive officer of Oraya Therapeutics.

The radiotherapy system’s delivery approach, targeting algorithm, unique eye stabilization, and tracking methods are all proprietary. The device has the CE mark and is considered investigational in the United States.

The results of the study will be presented during the EURETINA Congress in Milan, Italy, Sept. 6-9.

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