Eyenovia, Inc. announced on October 1, 2024, the commencement of manufacturing for registration batches of its FDA-approved mydriasis product, Mydcombi, utilizing its state-of-the-art Gen-2 Optejet dispensing platform.
This manufacturing step is crucial for the approval process of the Gen-2 Optejet, with Mydcombi undergoing 12-month stability testing and other functional tests. The company received consistent feedback from the FDA in July regarding its Gen-2 qualification plan.
The Gen-2 Optejet device is expected to offer significant advancements, including one-button use and compatibility with the OptiCare digital compliance monitoring program. This new generation device is also projected to provide substantially lower manufacturing costs and streamline future regulatory interactions for additional therapeutics.
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