Oraya Therapeutics, OnCore Manufacturing Develop Macular Degeneration Treatment

Oraya Therapeutics Inc. has teamed with OnCore Manufacturing LLC to develop a treatment for wet age-related macular degeneration (AMD), a disease characterized by abnormal growth of blood vessels in the macula that can lead to the rapid deterioration of visual acuity and blindness. The IRay Radiotherapy System is CE Marked and currently available for use in Switzerland and the United Kingdom.

The IRay is designed to offer a non-invasive approach for treating wet AMD and to reduce the number of anti-vascular endothelial growth (anti-VEGF) injections into the eye that are the current standard of care. Typically, patients are monitored monthly and may require five to seven injections annually to maintain vision. Oraya Therapy is the only therapy option on the market today that has demonstrated the ability to reduce anti-VEGF injections while maintaining or improving vision, according to the company.

“There is a critical need for new treatments for wet AMD, particularly those that can reduce the burden of anti-VEGF injections. The cost of monthly injections along with the high volume of patients requiring treatment place a strain on health care systems and providers, and are exceptionally difficult for patients and caregivers,” said Oraya President/CEO Jim Taylor. “We anticipate that Oraya will rapidly ramp up production in the coming months as more clinics offer the therapy and patient awareness grows.”

Oraya holds 44 patents associated with the IRay system, which consists of a low energy X-ray source that produces a highly collimated narrow beam designed to affect only the target area or lesion, with minimal scatter onto surrounding healthy tissue. A self-contained automated beam positioning system ensures the precise entry of energy into the eye, avoiding critical structures such as the lens and optic nerve. Specialized software ensures accurate treatment planning and precise beam positioning. A proprietary eye stabilization device, working with the beam positioning system, enables precise localization and tracking of the eye.

Oraya’s decision to partner with OnCore enables the company to focus on technology development while leveraging OnCore’s manufacturing and supply chain expertise at its Fremont, Calif., facility. Oraya, like a growing number of medical device and high technology companies, was looking to capitalize on the close proximity of its manufacturing partner to create an integrated IRay team that could reduce time-to-market.

“The medical device industry is looking for partners with exceptional engineering, supply-chain and manufacturing expertise, which they can leverage to accelerate their product commercialization process. Many are finding this expertise is here domestically,” said OnCore President/CEO Sajjad Malik. “We worked hand-in-hand with Oraya to manufacture the IRay, and we’re prepared to continue this partnership as Oraya expands into new geographic markets.”

Added Taylor: “Our close proximity and partnership with the team at OnCore’s Medical Center of Excellence manufacturing facility has allowed both companies to be very involved in the development and manufacture of the IRay, which has offered flexibility.”

The IRay is not available for sale in the United States.

Oraya Therapeutics Inc. is a privately held company in Newark, Calif., developing non-invasive therapies for diseases of the eye. The company was founded in 2007; its investors include Essex Woodlands Health Ventures, Domain Associates, Scale Venture Partners, and Synergy Life Science Partners.