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.