Eyenovia's Mydcombi for mydriasis approved by FDA

• The US FDA has approved Eyenovia's (NASDAQ:EYEN) Mydcombi using the company's own Optejet device to induce mydriasis and in situations where short term pupil dilation is needed.
• Mydcombi is a spray combining tropicamide and phenylephrine hydrochloride.
• The approval is the first for a fixed-dose combination of the two drugs.
• Company shares are down ~8% in Monday premarket trading.
• Mydcombi is the first FDA-approved product for Eyenovia (EYEN). It is expected to launch over the summer.

More on Eyenovia

• Eyenovia: Countdown To May 8, 2023

• Eyenovia rises on positive data from Optejet delivery technology trial