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Eyenovia’s Mydcombi Gets FDA Nod for Pupil Dilation

The US Food and Drug Administration (FDA) has approved Mydcombi (Eyenovia) for the dilation of pupils during diagnostic procedures.

The ophthalmic spray, made of 1% tropicamide and 2.5% phenylephrine hydrochloride, is the first agent approved for use with Eyenovia’s Optejet dispenser, which distributes a fine mist that coasts the surface of the eye.

“The use of eye dropper bottles has presented challenges for dosing in ophthalmologic settings in millions of patients,” Sean Ianchulev, MD, founder of Eyenovia and chairman of its board of directors, said in a press release about the FDA approval. “We can do better now using sophisticated micro-array print delivery with physiologic dosing that is similar to the natural tear film volume.”

The company said the product can be used for mydriasis prior to cataract surgery and for comprehensive eye exams.

Eyenovia said it will begin internal manufacturing for a 2024 rollout.

Clinicians should use caution in applying the drug in patients with cardiovascular disease and hyperthyroidism because of significant elevations in blood pressure, the company said. Common adverse reactions in clinical trials included transient blurred vision, reduced visual acuity, photophobia, and increased intraocular pressure. Some cases of rebound miosis were reported 1 day post administration.

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