FDA approves ophthalmic spray for mydriasis
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Key takeaways:
- Eyenovia’s Mydcombi is a fixed-combination of tropicamide and phenylephrine administered as a spray for short-term pupil dilation.
- The product will be released to select offices in summer 2023.
The FDA has approved Eyenovia’s Mydcombi ophthalmic spray for inducing mydriasis, the company announced in a press release.
The fixed-combination of tropicamide 1% and phenylephrine 2.5% is administered through the Optejet device during diagnostic procedures and for short-term pupil dilation.
“This represents the first approved fixed-dose combination of tropicamide and phenylephrine in the U.S. and also the first product using Eyenovia’s proprietary Optejet device to be approved by any regulatory authority,” the company said in the release.
“We look forward to introducing Mydcombi to key offices beginning this summer, while we bring our internal manufacturing capabilities online for 2024,” Eyenovia CEO Michael Rowe said in the release.
“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 (pilocarpine) for presbyopia, but our partnered programs as well,” Rowe continued. “We see opportunities to unlock significant opportunities in the future treatment of other ophthalmic conditions including glaucoma and dry eye.”
“The use of eye dropper bottles has presented challenges for dosing in ophthalmologic settings in millions of patients,” Eyenovia founder and board chair Sean Ianchulev, MD, MPH, said in the release. “We can do better now using sophisticated micro-array print delivery with physiologic dosing that is similar to the natural tear film volume.”
Perspective
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Eyenovia's approval of MydCombi is important because it will acquaint clinicians for the first time with a novel way of dispensing eye medications without drops. The Optejet handheld device, developed by Sean Ianchulev, MD, MPH, dispenses about 8 µL of fluid into the eye, less than half the volume of a typical drop, which means less exposure of both drug and preservative to the eye and body. Patients can keep their head upright, which is much more comfortable for people with neck and back problems. I've dispensed vehicle into my own eye with this device, and it is much more comfortable than eye drops.
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