Eyenovia announces FDA approval of first ophthalmic spray for mydriasis

Betsy Goodfellow | May 10, 2023 | News story | Research and Development Eyenovia, FDA, Opthalmology, mydriasis, ophthalmology 

Ophthalmic technology company Eyenovia has announced that the US Food and Drug Administration (FDA) has approved 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 needed.

This approval marks the first of a fixed dose combination of tropicamide and phenylephrine in the US and the first product using Eyenovia’s proprietary Optejet device to be approved by any regulatory authority.

Further updates on Mydcombi and its ongoing development programmes are expected throughout 2023.

Michael Rowe, chief executive officer of Eyenovia, commented: “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 programme 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 programmes, including MicroLine for presbyopia, but our partnered programmes as well. 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.”

Dr Sean Ianchulev, founder and chairman of Eyenovia’s board of directors, added: “I am proud of our team for this significant achievement – which represents many ‘firsts’ for eye care. 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 micro-array print delivery with physiologic dosing that is similar to the natural tear film volume.”

Betsy Goodfellow

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