Navigating Regulatory Complexities In EV-Based Dermatology Therapies

In this segment of Cell & Gene Live, Redefining CGTs with Exosomes and EVs, Aegle Therapeutics’ Dr. Gloria Matthews highlights the lack of clear regulatory guidance for potency assays as a major hurdle in advancing EV-based therapies, particularly due to the complex and not fully understood mechanisms of action. Their regulatory strategy focuses on indication-specific assays, currently for wound healing and epidermolysis bullosa, while recognizing the difficulty in scaling that approach for a broad pipeline. Commercially, Aegle is one of the few EV companies in the clinic and is uniquely positioned in dermatology, distinguishing itself through a proprietary, more effective manufacturing method and by leveraging the full spectrum of extracellular vesicles rather than just exosomes.