NEW YORK—Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, has announced that it has commenced manufacturing of registration batches of its FDA-approved mydriasis product, Mydcombi, a key step in the approval process for its Gen-2 Optejet dispensing platform. According to the announcement, Mydcombi will undergo 12-month stability testing and other functional testing in the Gen-2 Optejet device that is consistent with feedback from the Type-C meeting on Eyenovia’s device qualification plan that the company received from the Food and Drug Administration (FDA) in July.

“We were very pleased to have received feedback from the FDA that was very consistent with our Gen-2 qualification plan, allowing us to move forward with manufacturing and testing as quickly and efficiently as possible,” stated Michael Rowe, chief executive officer of Eyenovia.

“With advances from the prior generation product, including one-button use and compatibility with our digital compliance monitoring program, Optecare, we view the introduction of the Gen-2 Optejet as a significant upcoming inflection point for our company.”

He added, “Importantly, the work that we are doing for Mydcombi in the Gen-2 Optejet device may also provide significantly lower manufacturing costs and streamline future regulatory interactions as we expand the Gen-2 platform to additional therapeutics, both within our own pipeline as well as those in development partnerships, such as dry eye.”

Eyenovia said it anticipates completion of testing of its Mydcombi registration batches by the end of next year, with a potential supplemental new drug application filing in early 2026.