Eyenovia has received approval from the US Food and Drug Administration (FDA) for its Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis during diagnosis and in cases where short-term pupil dilation is required.

Mydcombi is said to be the first approved fixed-dose combination of tropicamide and phenylephrine in the US. It is a drug-device combination that uses Eyenovia’s proprietary drug delivery device Optejet.

The ophthalmic technology company has designed Mydcombi to enhance the efficiency of office-based comprehensive eye exams and pharmacologic mydriasis applications for cataract surgery.

Eyenovia CEO Michael Rowe said: “The approval of Mydcombi, our first FDA approved product, represents the culmination of years of tireless effort by the entire Eyenovia team, and I would like to express my sincere gratitude to the associates and technical experts who helped advance this important program through this transformational milestone.

“We look forward to introducing Mydcombi to key offices beginning this summer while we bring our internal manufacturing capabilities on-line for 2024.

“Perhaps more importantly, FDA approval of Mydcombi provides critical validation of the Optejet as it is the first product approved using the Optejet platform, which is core not only to our internal development programs, including MicroLine for presbyopia, but our partnered programmes as well.”

In October 2021, the FDA reclassified Mydcombi as a drug-device combination product. The reclassification came in a complete response letter (CRL) by the regulator for Eyenovia’s new drug application (NDA).

Last December, the FDA accepted for review an NDA for the MydCombi ophthalmic spray for in-office pupil dilation, administered through the investigational Optejet drug delivery technology.