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news.Isolagen, an aesthetic and therapeutic company, has submitted a biologics license application to the FDA for Isolagen Therapy, its first-in-class cellular therapy for the treatment of wrinkles or nasolabial folds.
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The company’s wrinkles or nasolabial folds Phase III trials were conducted under an FDA special protocol assessment.
Isolagen currently estimates that its unrestricted, available cash resources will allow the company to continue in operation for approximately three weeks. The company continues to pursue potential financing alternatives and potential strategic partnership discussions. Further, the company is pursuing the potential sale of its 57% ownership interest in Agera Laboratories.
Declan Daly, CEO and president of Isolagen, said: “This biologics license application submission is a significant regulatory milestone for 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.”