Isolagen, Inc has submitted a Biologics License Application (BLA) for Isolagen Therapy, a novel, first-in-class cellular therapy for the treatment of wrinkles or nasolabial folds, to the US Food and Drug Administration (FDA). The company's wrinkles or nasolabial folds phase-III trials were conducted under an FDA Special Protocol Assessment.
"This BLA submission is a significant regulatory milestone for Isolagen," said Declan Daly, chief executive officer and president of Isolagen. "We believe that the Isolagen Therapy, if approved, would represent a new class of treatment in the facial aesthetic arena whereby patients will receive their own cells to repair the skin. We look forward to working with the FDA as it reviews our application. I am extremely proud of our employees and their efforts in accomplishing this significant goal for the company. Further, I would like to recognize and extend my appreciation to our investigators and our regulatory and clinical advisors for all of their dedicated efforts."
Daly continued, "In addition to submitting our first BLA to the FDA, the company has recently completed its phase-II/III trial for the treatment of acne scars with statistically significant efficacy results. I believe Isolagen represents a platform technology with an extensive pipeline of potential indications, such as the treatment of wrinkles, acne scars, burn scars and stretch marks. The company is actively pursuing financing and/or strategic partnerships."
Isolagenis an aesthetic and therapeutic company committed to developing and commercializing scientific advances and innovative technologies.