Eyenovia Begins Manufacturing Mydcombi for Gen-2 Optejet Platform, Eyes FDA Progress
Portfolio Pulse from Benzinga Newsdesk
Eyenovia, Inc. has started manufacturing registration batches of its FDA-approved mydriasis product, Mydcombi, for the Gen-2 Optejet platform. This step is crucial for FDA approval, with testing expected to complete by the end of next year and a potential SNDA filing in early 2026.
October 01, 2024 | 11:07 am
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Eyenovia has commenced manufacturing Mydcombi for its Gen-2 Optejet platform, a key step towards FDA approval. The process includes 12-month stability testing, with potential cost benefits and streamlined regulatory interactions.
The commencement of manufacturing Mydcombi for the Gen-2 Optejet platform is a significant step towards FDA approval, which could positively impact Eyenovia's stock. The potential for lower manufacturing costs and streamlined regulatory processes further enhances the positive outlook.
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