Eyenovia announced the FDA acceptance of their new drug application for MydCombi.
What is MydCombi?
MydCombi is a drug-device combination product that comprises the company’s proprietary, first-in-class combination of tropicamide and phenylephrine for in-office pupil dilation administered via the investigational Optejet drug delivery technology.
Have I heard of this Optejet technology before?
Probably. Eyenovia has two other drugs in development using this technology, MicroLine (for presbyopia) and MicroPine (for myopia treatment).
When will we hear more?
The FDA has set a PDUFA date for May 8, 2023.