ONL RECEIVES ORPHAN DRUG DESIGNATION FOR ONL-101 IN RETINAL DETACHMENT

ONL RECEIVES ORPHAN DRUG DESIGNATION FOR ONL-101 IN RETINAL DETACHMENT
March 19, 2013

Ann Arbor, Mich. (March 19, 2013) — ONL Therapeutics today announced that it has received an orphan drug designation form the FDA for ONL-101 in its lead indication of retinal detachment. Orphan drug designation provides drug developers multiple benefits including qualification for certain tax incentives related to clinical development and seven years of market exclusivity in the orphan disease, in this case retinal detachment, should the drug be approved as safe and effective.

ONL-101 is small peptide currently in pre-clinical development that protects photoreceptors by blocking the FAS apoptosis pathway that is activated in many retinal diseases, including retinal detachment, age-related macular degeneration, diabetic retinopathy and retinopathy of prematurity. Retinal detachment is the lead indication for ONL-101, but the company plans to pursue additional indications once it has achieved clinical proof-of-concept in retinal detachment.

“We are pleased that our application was accepted,” said ONL Co-Founder and Chief Medical Officer David Zacks. “Retinal detachment is a condition that affects more than 100,000 Americans each year.”

“I have been frustrated as a retinal surgeoun that while surgery has a 90% anatomical success rate, more than 40% of patients with detachments involving the macula (their central vision) do not have driving vision post-surgery in the affected eye,” Zacks continued. “There is a significant and growing need for drugs to protect photoreceptors between the detachment event and the surgery I can perform. I believe our drug will fulfill that need.”

About ONL Therapeutics, LLC.
ONL Therapeutics is dedicated to preventing blindness and improving visual outcomes. Our novel drug programs targeting the FAS apoptotic pathway provide protection for photoreceptors while the underlying disease can be addressed with surgery or concurrent therapies. Photoreceptor cell death is the primary cause of blindness and therapies to protect these cells are crucial if visual outcomes are to improve.