Treatment will benefit millions”of patients, says Eyenovia, the company that developed the product.
The FDA approved Eyenovia’s Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. This represents the first approved fixed dose combination of tropicamide and phenylephrine in U.S. and also the first product using Eyenovia’s proprietary Optejet device to be approved by any regulatory authority, the pharma maker said.
There is a large patient population for the new treatment as Mydcombi is designed to improve the efficiency of the estimated 106 million office-based comprehensive eye exams performed annually in the U.S. as well as the estimated four million pharmacologic mydriasis applications for cataract surgery.
Eyenovia, which is headquartered in New York, plans to introduce Mydcombi to key offices beginning this summer while “we bring our internal manufacturing capabilities online for 2024,” CEO Mike Rowe said.
“I am proud of our team for this significant achievement — which represents many ‘firsts’ for eye care,” said Sean Ianchulev, M.D., M.P.H., 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 micro-array print delivery with physiologic dosing that is similar to the natural tear film volume.”
Eyenovia expects to “unlock significant opportunities in the future treatment of other ophthalmic conditions including glaucoma and dry eye,” Rowe added.
Eyenovia originally developed the Optejet device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications. Then, in October 2021, the FDA reclassified Optejet as a drug-device combination.
FDA’s acceptance of MydCombi’s new drug application (NDA) in March 2021 was based on the Phase 3 MIST-1 and MIST-2 studies.
A fixed combination of micro-dosed tropicamide 1% and phenylephrine 2.5% ophthalmic solution met the studies’ primary endpoints and was shown to be well-tolerated and effective for pharmacologic mydriasis, Eyenovia said. Approximately 94% of treated eyes achieved 6 mm or greater dilation at 35 minutes post-instillation. Adverse events were infrequent, with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia or instillation site pain.
The medication is contraindicated for patients with known hypersensitivity to any component of the formulation.
Eyenovia management will provide additional updates on Mydcombi and ongoing development programs and partnerships during its regularly scheduled first quarter 2023 update conference call and webcast on May 11.
Eyenovia did not respond to Formulary Watch’s requests for comment.