BioTime announced the expansion of its ongoing phase 1/2a clinical trial for OpRegen in the advanced dry form age-related macular degeneration (AMD) by naming the first two sites that will treat patients in the United States.
“The addition of U.S. clinical trial sites is an important step in the acceleration of our clinical development program for OpRegen,” Adi Mohanty, Co-chief Executive Officer of BioTime, said in a company news release. “We are honored to be working with two of the leading US clinicians in ophthalmology, David S. Boyer, MD, and H. Richard McDonald, MD. The sites are currently going through the set-up process, and we anticipate enrolling and treating U.S.-based patients by the end of the second quarter.”
Dr. Boyer is an ophthalmologist and senior partner with Retina-Vitreous Associates Medical Group in Los Angeles. He is a renowned clinician, surgeon and educator specializing in the treatment of diseases of the retina and vitreous. Dr. Boyer is one of the leading retinal clinical researchers in the country for new treatments in macular degeneration and diabetic macular edema. A widely-published author and avid lecturer, he lectures nationally and internationally on retinal research and the innovative approach to the treatment of retinal diseases.
Dr. McDonald is an ophthalmologist and senior partner at West Coast Retina Medical Group in San Francisco. He is the President-elect of the Macula Society and a long time member of the Retina Society and American Society of Retinal Specialists. Dr. McDonald is a Section Editor of the Journal Retina, lectures nationally and internationally, and has written numerous papers, book chapters and editorials. He has received the Lifetime Achievement award from the American Academy of Ophthalmology.
OpRegen is an investigational therapy in which retinal pigment epithelial (RPE) cells are introduced into the subretinal space where they are intended to replace missing RPE cells. The ongoing trial is a phase 1/2a dose escalation study evaluating the safety and efficacy of three different dose regimens of OpRegen in patients with the advanced form of dry AMD accompanied by geographic atrophy. Data recently presented from the first patient cohort indicate that at the first dose, OpRegen caused no serious adverse events, and retinal imaging suggests the presence and survival of transplanted cells in the subretinal space for up to one year. Data from the cohort were presented at the International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) in Rome, on December 2, 2016 and at the Angiogenesis meeting in Miami, Florida on February 11, 2017.
“I am excited about the potential of BioTime’s OpRegen for the treatment of dry-AMD, the leading cause of blindness in the elderly,” Dr. Boyer said in the news release. “In my practice I routinely encounter patients who are suffering from various stages of dry AMD, a debilitating condition for which no currently approved therapy exists. I would like nothing more than to be able to offer my patients an effective treatment for it, especially one that may be able to preserve and possibly even help restore function. Data on the first patient cohort and progress to date is very encouraging, and I am eagerly anticipating treating patients.”
“Dry AMD is the only major eye disease for which no treatment is available and it affects a significantly higher number of people than the wet form of AMD. I look forward to the initiation of this important clinical trial to see if this treatment can arrest and potentially reverse the course of this disease, which inevitably leads to blindness,” said Dr. McDonald.