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Mydcombi FDA Approval History

Last updated by Judith Stewart, BPharm on May 9, 2023.

FDA Approved: Yes (First approved May 5, 2023)
Brand name: Mydcombi
Generic name: phenylephrine hydrochloride and tropicamide
Dosage form: Ophthalmic Spray
Company: Eyenovia, Inc.
Treatment for: Pupillary Dilation

Mydcombi (phenylephrine hydrochloride and tropicamide) is an alpha-1 adrenergic receptor agonist and anticholinergic fixed-combination ophthalmic spray indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired.

  • Mydcombi contains phenylephrine hydrochloride 2.5% and tropicamide 1% which is administered via the Optejet® dispenser as a micro-mist that coats the eye.
  • The Optejet® dispenser uses high-precision piezo-print technology to deliver 0.008 mL of solution, which is less than 20% of that delivered using conventional eyedroppers, thus reducing overdosing and exposure to drug and preservatives. The solution is dispensed to the ocular surface in approximately 80 milliseconds, which is faster than the ocular blink reflex.
  • Mydcombi is administered as one metered spray to the cornea of the eye to be dilated, and repeated after 5 minutes. In pediatric patients younger than 1 year of age, one metered spray is administered to the cornea of each eye to be dilated, up to a maximum of 3 sprays per eye per day.
  • Warnings and precautions associated with Mydcombi include significant elevations in blood pressure in at risk patients, central nervous system disturbances, transient elevation in intraocular pressure, and rebound miosis.
  • Common ocular adverse reactions include transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort. Increased intraocular pressure has been reported following the use of mydriatics.
    Common systemic adverse reactions may include dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity.

Development timeline for Mydcombi

May  8, 2023Approval FDA Approves Mydcombi (tropicamide and phenylephrine hydrochloride) Ophthalmic Spray for Inducing Mydriasis
Dec 13, 2022Eyenovia Announces FDA Acceptance of New Drug Application for MydCombi™ for In-Office Pupil Dilation
Mar  2, 2021Eyenovia Announces FDA Acceptance of the MydCombi NDA
Dec 29, 2020Eyenovia Submits New Drug Application to FDA for Pharmacologic Mydriasis with MydCombi

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.