Earlier today, Aimed Alliance’s Director of Public Policy, Stacey L. Worthy, submitted a comment to the U.S. Food and Drug Administration (FDA) regarding concerns that the FDA departed from their long-standing policies and practices regarding bioequivalence determinations for complex ophthalmic treatments. The FDA is poised to approve of abbreviated new drug applications (ANDAs) for cyclosporing ophthalmic emulsion that based solely on laboratory tests to demonstrate bioequivalence, when in fact there is widespread consensus among ophthalmology specialists that thorough testing on human eyes is necessary.
Moreover, numerous advocacy organizations and professional ophthalmology societies urged the FDA to consult eye care specialists about modifying current testing requirements, which the agency failed to do. In light of these issues, Aimed Alliance’s comment encourages the FDA to refrain from approving any ANDAs for cyclosporine ophthalmic emulsion right now. Read the letter in full here: Aimed Alliance Comments to FDA on Ophthalmic Emulsions
Last Updated on May 7, 2020 by Aimed Alliance
