BioTime Announces New Positive Data from OpRegen® Trial in Dry-AMD
ALAMEDA, Calif.–(Business Wire)–BioTime, Inc., a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, today announced new data from the Phase I/IIa clinical trial of OpRegen® in the advanced form of dry age-related macular degeneration (dry-AMD). The interim data were presented on May 8, 2017 at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Baltimore, Maryland by Eyal Banin, M.D., Ph.D.
“We are encouraged by the results and look forward to the next steps in moving this therapeutic through the clinic and addressing the needs of the millions of patients with dry-AMD,” said Adi Mohanty, Co-Chief Executive Officer.
The presentation at ARVO reported new clinical trial data with two patients that were treated in cohort 2, where they received a dose of 200,000 cells. Imaging analysis suggests the transplanted OpRegen cells remained in place (engrafted) in an area of the scar that was completely depleted of retinal pigment epithelium (RPE) because of the advanced stages of the disease. Cell engraftment occurred in four of the five patients treated thus far. There was also possible evidence of a biological response with some areas appearing to show structural improvement (a thickening of the thinned area of retina above the scar) without any signs of retinal edema, a fluid build-up that can further compromise vision.
“I am excited to see that the second cohort is showing evidence of cell survival and early signs suggesting a biological response,” stated Dr. David Boyer, senior partner at Retina-Vitreous Associates Medical Group in Los Angeles and a principal investigator for the OpRegen trial. “I am looking forward to treating patients in the U.S. under this trial protocol.”
Best corrected visual acuity (BCVA) remained stable in all treated eyes and importantly showed no signs of deterioration, which could be expected if no treatment was given. The data also continues to show that the procedure is well tolerated in all patients, including those patients with follow-up for more than one year after treatment……
Source: Digital Journal
Image: BioTime property of BIOTIME