■ FDA has approved the first fixed-dose combination of tropicamide and phenylephrine for mydriasis in the United States. Eyenovia’s Mydcombi, delivered by the company’s proprietary OpteJet, “is designed to improve the efficiency of the estimated 106 million office-based comprehensive eye exams performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery,” according to a news release. Mydcombi is the first product approved to use the company’s Optejet platform, which CEO Michael Rowe says is core to its business.

“We see opportunities to unlock significant opportunities in the future treatment of other ophthalmic conditions, including glaucoma and dry eye. I am confident in our ability to maintain our current momentum,” Rowe said.

“I am proud of our team for this significant achievement — which represents many ‘firsts’ for eye care,” stated Dr. Sean Ianchulev, founder and chairman of Eyenovia’s board of directors. “The use of eye dropper bottles has presented challenges for dosing in ophthalmologic settings in millions of patients. We can do better now using sophisticated microarray print delivery with physiologic dosing that is similar to the natural tear film volume.”