Eyenovia Announces Commencement of Manufacturing of its Advanced, Second Generation Optejet Device

Core Insights - Eyenovia, Inc. has begun manufacturing registration batches of its FDA-approved mydriasis product, Mydcombi, marking a significant step in the approval process for its Gen-2 Optejet dispensing platform [1][2]. Group 1: Product Development - Mydcombi will undergo 12-month stability testing and functional testing in the Gen-2 Optejet device, following FDA feedback received in July [2]. - The Gen-2 Optejet device features advancements such as one-button use and compatibility with the digital compliance monitoring program, Optecare™ [3]. Group 2: Strategic Outlook - The introduction of the Gen-2 Optejet is viewed as a significant inflection point for the company, potentially leading to lower manufacturing costs and streamlined regulatory interactions for future therapeutics [3]. - Eyenovia anticipates completing testing of Mydcombi registration batches by the end of next year, with a potential SNDA filing in early 2026 [4]. Group 3: Company Overview - Eyenovia is focused on the commercialization of Mydcombi for mydriasis and is developing additional products, including clobetasol propionate ophthalmic suspension and treatments for pediatric progressive myopia [5].