Eyenovia’s MydCombi Reclassified by FDA as Drug-Device Combination

The FDA has reclassified MydCombi, Eyenovia’s microdose formulation of tropicamide and phenylephrine for in-office pupil dilation, as a drug-device combination product.

The New York City-based company is developing a range of microdose array printed therapeutics for delivery of targeted eye treatments using its Optejet dispenser.

The reclassification came in a complete response letter the FDA sent the company Oct. 22 over its new drug application for MydCombi.

Eyenovia said it will provide additional information the FDA has requested relating to the new drug-device classification.