The Food and Drug Administration (FDA) has approved Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired.
MydCombi is a fixed microdose combination of tropicamide, an anticholinergic, and phenylephrine hydrochloride, an alpha-1 adrenergic receptor agonist. Treatment is administered as 1 metered spray to the cornea of each eye to be dilated. The onset of action is 15 to 30 minutes with maximal mydriasis occurring in 20 to 90 minutes.
The approval was based on data from the phase 3 MIST-1 and MIST-2 studies (ClinicalTrials.gov Identifier: NCT03751631, NCT03751098, respectively), which evaluated the efficacy and safety of Mydcombi for pharmacologic mydriasis. The primary endpoint for both studies was the mean change in 35-minute pupil diameter from baseline as measured by digital pupillometry in highly photopic conditions.
Findings showed Mydcombi was statistically superior to tropicamide 1% and phenylephrine 2.5% administered alone. In MIST-1, the mean change in pupil diameter was 4.7mm with Mydcombi at 35 minutes post-dose compared with 4.1mm with tropicamide and 0.9mm with phenylephrine. In MIST-2, the mean change in pupil diameter was 4.8mm with Mydcombi compared with 0.1mm with placebo.
Additionally, 94% of eyes administered Mydcombi achieved 6mm or greater dilation at 35 minutes post-instillation compared with 78% of eyes administered tropicamide alone, 1.6% of eyes administered phenylephrine alone, and 0% of eyes administered placebo. Treatment differences in mydriasis were observed as early as 20 minutes and were sustained at 180 minutes post-dose.
The most common ocular adverse reactions reported were transient blurred vision, visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort.
Mydcombi is supplied as a cartridge containing approximately 180 sprays.
“We look forward to introducing Mydcombi to key offices beginning this summer while we bring our internal manufacturing capabilities on-line for 2024,” said Michael Rowe, chief executive officer of Eyenovia.
- Eyenovia announces FDA approval of Mydcombi™, the first ophthalmic spray for mydriasis, which also leverages the Company’s proprietary Optejet® device platform. News release. Eyenovia. Accessed May 8, 2023. https://www.globenewswire.com/news-release/2023/05/08/2663251/0/en/Eyenovia-Announces-FDA-Approval-of-Mydcombi-the-First-Ophthalmic-Spray-for-Mydriasis-Which-Also-Leverages-the-Company-s-Proprietary-Optejet-Device-Platform.html.
- Package insert. Eyenovia; 2023. Accessed May 8, 2023. https://mydcombi.com/wp-content/uploads/2023/05/MydCombi-PI-05072023.pdf.