Eyenovia Inc. 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 a press release.

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 FDA in July. Eyenovia 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.