ANN ARBOR — RetroSense Therapeutics, a gene therapy company dedicated to vision restoration, announced completion of a pre-IND meeting with the Center for Biological Evaluation and Research division of the FDA that took place on May 22 regarding RetroSense’s lead product candidate, RST-001 for vision restoration in retinal degenerative conditions.
The purpose of the meeting was to obtain CBER’s guidance for the clinical path to a Biologics License Application for RST-001 in the US, and clarity on the steps required for Investigational New Drug submission. The discussions included manufacturing criteria, the scope and design of the preclinical studies, and the scope and design of Phase I and IIa clinical trials.
Sean Ainsworth, CEO, noted, “We were quite encouraged by the FDA’s feedback and comments and identified nothing that will hinder our path to the clinic. RetroSense remains on schedule to bring RST-001 to the clinic safely and expeditiously.”
Peter Francis, MD, PhD, Clinical Director, led the meeting. Dr. Francis stated, “It was a successful, productive interaction with the FDA. We were thankful to have representation by Foundation Fighting Blindness, who have been supportive of our novel approach to vision restoration.”
“We are very excited about the potential for this innovative treatment to restore vision in people who are blind from retinal degenerations,” says Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “It is an elegant and powerful approach to overcoming devastating eye diseases.”
RetroSense Therapeutics is a biotechnology company developing a gene therapy to restore vision in patients suffering from blindness due to retinitis pigmentosa and advanced dry age-related macular degeneration. There are currently no FDA approved therapies to improve or restore vision in patients with these retinal degenerative conditions. RetroSense is led by a team of seasoned veterans with deep experience in taking products from the discovery stage through to the clinic. For more information about RetroSense, visit http://www.retro-sense.com/.
The Foundation Fighting Blindness is a national non-profit organization driving research that will lead to preventions, treatments and cures for retinitis pigmentosa, macular degeneration, Usher syndrome and the entire spectrum of retinal degenerative diseases that affect more than 10 million Americans. Since 1971, the Foundation has raised over $450 million as the leading non-governmental funder of retinal research. Breakthrough Foundation-funded studies using gene therapy have restored significant vision in children and young adults who were previously blind, paving the way for using this method to treat a variety of retinal degenerative diseases, and proving a cure is in sight. With a network of 50 chapters, the Foundation also provides support, education and resources to affected individuals and their families in communities across the country.