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The approval, granted to Eyenovia, Inc, represents the first-approved fixed-dose combination of tropicamide and phenylephrine for inducing mydriasis for diagnostic procedures and short-term pupil dilation.
Today, the US Food and Drug Administration (FDA) approved tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5% (Mydcombi) for inducing mydriasis for diagnostic procedures and in desired conditions for short-term pupil dilation.1
The approval, granted to Eyenovia, Inc., represents the first fixed-dose combination of tropicamide and phenylephrine in the US and the first product approved to use the company’s proprietary Optejet® device by any regulatory authority.
“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,” said Michael Rowe, chief executive officer, Eyenovia.1 “We look forward to introducing Mydcombi to key offices beginning this summer while we bring our internal manufacturing capabilities on-line for 2024.”
The drug-device combination product comprises the first-in-class combination of tropicamide and phenylephrine for pharmacological mydriasis, administered via the investigational Optejet® drug delivery technology. It was designed to improve the efficiency of the estimated 106 million office-based comprehensive eye exams performed every year in the US and the estimated 4 million pharmacologic mydriasis applications for cataract surgery.
In October 2021, the company received a Complete Response Letter (CRL) from the FDA to their New Drug Application (NDA) for Mydcombi, reclassifying it as a drug-device combination product. The CRL requested that the company conduct additional device testing related to the Optejet® dispenser, but no additional clinical studies of MydCombi were requested. The resubmitted NDA for MydCombi was accepted in December 2022 and was supported by the completed phase 3 MIST-1 and MIST-2 clinical trials.2
The MIST-1 trial compared MydCombi to phenylephrine alone and tropicamide alone, while MIST-2 compared MydCombi to placebo. Results from both phase 3 studies showed a fixed combination of micro-dosed tropicamide 1% and phenylephrine 2.5% ophthalmic solution was safe and effective for pharmacologic mydriasis. Approximately 94% of treated eyes achieved 6mm or greater dilation at 35 minutes post-instillation, with infrequent adverse events.3
The most common ocular adverse reactions linked to MydCombi included transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort. As well, increased intraocular pressure has been reported after the use of mydriatics. The company noted the product is contraindicated and should not be used in patients with known hypersensitivity to any component of the formulation.
The company also indicated the FDA approval of the ophthalmic spray represented a critical validation of the Optejet platform. Based on this approval, they cited the opportunities to use the platform in the future treatment of other ophthalmic conditions, including glaucoma and dry eye disease.
“I am proud of our team for this significant achievement – which represents ‘firsts’ for eye care,” said Sean Ianchulev, Founder and Chairman of Eyenovia’s Board of Directors.1 “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.”