> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Eyenovia’s Pupil Dilator Approved by FDA
- URL: https://www.fdaweb.com/eyenovias-pupil-dilator-approved-by-fda/
- Published: 2023-05-08T12:00:00.000Z
- Updated: 2026-09-14T18:30:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154389

FDA has approved Eyenovia’s Mydcombi (tropicamide and phenylephrine HCl ophthalmic spray) for inducing mydriasis for diagnostic procedures and in situations when short term pupil dilation is needed. The company says the device was designed to improve the efficiency in office-based eye exams, as well as pharmacologic mydriasis applications for cataract surgery. The product uses the company’s Optejet platform, which is also being evaluated for uses in glaucoma and dry eye, it says.

Eyenovia says that the most common ocular adverse reactions associated with Mydcombi include transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort. It also says increased intraocular pressure has been reported following the use of mydriatics.