■ The FDA has accepted Eyenovia’s NDA for MydCombi ophthalmic spray, according to the company. The drug-device combination product includes a proprietary tropicamide and phenylephrine combination for in-office mydriasis administered via the investigational Optejet drug delivery technology.
“If approved, MydCombi would be the first commercial product to leverage our proprietary Optejet drug delivery device,” said Eyenovia CEO Michael Rowe in a news release.
The MydCombi NDA is supported by the phase 3 clinical trials MIST-1 and MIST-2. The former compared MydCombi to phenylephrine alone and tropicamide alone, and the latter compared MydCombi to placebo. All treatments were administered using Optejet.
Eyenovia also announced positive results from a collaborative study with Pedram Hamrah, MD, interim chairman of ophthalmology at Tufts Medical Center. The in vitro investigation evaluated the gene and protein expression of cytokines and chemokines after latanoprost plus benzalkonium chloride (BAK) treatment administered via Optejet vs the same combination delivered in a traditional drop.
“Chronic treatment of glaucoma with BAK preserved topical ophthalmic medications introduces ocular surface stress and may trigger a vicious cycle of inflammation,” said Dr. Hamrah in the news release. “Unfortunately, the majority of glaucoma patients treated long term with drops eventually succumb to the associated inflammatory effects and discomforts of ocular surface disease.”
The Optejet shows lower levels of proinflammatory cytokines and chemokines than standard drops, said Julie Whitcomb, PhD, Eyenovia’s senior director of medical affairs. “The current study further underscores that precision dosing of drug and preservatives by the Optejet decreases inflammation.”