In May, the FDA approved the Mydcombi treatment for use with Optejet. New York-based Eyenovia designed Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. Its approval marked the first approved fixed-dose combination of tropicamide and phenylephrine in the U.S.
The FDA nod was also the first for a product using Eyenovia’s proprietary Optejet device.
Eyenovia said in a news release that it made its first sale to board-certified opthalmologist Dr. Nathan M. Radcliffe. Radcliffe became the first physician in the U.S. to incorporate Mydcombi into his daily practice.
“We are very pleased to initiate sales of Mydcombi to select professional offices so that ophthalmologists, optometrists, technicians and their patients can experience the benefits of Mydcombi’s metered spray delivery relative to conventional multiple eye drops,” said Michael Rowe, CEO of Eyenovia. “We have now kicked off our targeted launch while we continue to ramp up our internal manufacturing capabilities.”
Eyenovia designed Mydcombi to streamline office-based comprehensive eye exams with pupil dilation. Clinical studies demonstrated its superiority to tropicamide and to phenylephrine administered alone. It produced effective pupil dilation in almost two-thirds of patients seen as early as 20 minutes after application.
“I have been eagerly awaiting the commercial availability of Mydcombi to provide a great experience to my patients who require pupil dilation,” said Radcliffe. “In addition, given the potential for streamlining patient throughput that Mydcombi may facilitate, I anticipate that it will be the go-to mydriasis agent in my own practice going forward.”
