Manufacturing registration batches of the FDA-approved Mydcombi mydriasis product marks a key step in the approval process for the company’s state-of-the-art Gen-2 Optejet dispensing platform, according to a news release. The company plans to have Mydcombi undergo 12-month stability testing and other functional testing in the device. It intends to follow the feedback received in a device qualification plan from the FDA in July.
New York-based Eyenovia designed Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions requiring short-term pupil dilation.
Its approval marked the first approved fixed-dose combination of tropicamide and phenylephrine in the U.S. The company aims for Mydcombi to improve the efficiency of office-based, comprehensive eye exams.
Eyenovia expects to complete testing by the end of next year, potentially filing for regulatory approval in early 2026. CEO Michael Rowe says the developments could deliver fewer manufacturing costs and streamline future regulatory interactions.
“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,” said Rowe. “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.”
