Eyenovia Plans to Seek US FDA Clearance for Gen-2 Optejet Microdoser

Eyenovia announced in its Q2-2024 financial results that it planned to seek marketing clearance for an advanced Gen-2 Optejet microdoser.

Eyenovia, of New York, said production was expected to begin in Q4-2024, followed by regulatory submission in 2025 with Mydcombi as the lead product.

Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% was approved in May 2023 for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired.

Eyenovia said its Gen-2 device was developed to be easier to use and manufacture, bringing the cost of goods for the monthly cartridge toward the company’s goal of $20.

Eyenovia recently announced collaboration agreements with Senju Pharmaceutical and SGN Nanopharma to develop novel dry eye treatments for use with the Optejet.