NEW YORK - Eyenovia, Inc. (NASDAQ: NASDAQ:EYEN), a commercial-stage ophthalmic company, today announced positive results from a Phase IV study of its FDA-approved product, Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%. The study aimed to determine the efficacy and duration of the product's lowest deliverable dose for pupil dilation.
The research, conducted at the State University of New York School of Optometry, involved 29 subjects who received a half dose (8µL per eye) of Mydcombi. Findings indicated that 67% of patients achieved clinically relevant pupil dilation within 30 minutes post-dose, and the number increased to 86% by the 60-minute mark.
The majority of patients' pupil sizes returned to less than 5mm between 3.5 and 6 hours after instillation, with 93% reaching this point by 6 hours. The lower volume of Mydcombi was well tolerated, with minimal adverse events reported.
Michael Rowe, Eyenovia's CEO, highlighted the study's significance, noting that the results demonstrate the efficacy and tolerability of Mydcombi when administered with the Optejet technology.
He mentioned that the dilation began to dissipate as early as 3.5 hours post-instillation, which aligns with studies involving mydriasis reversal agents. The precision and flexibility of the Optejet technology could provide an option for eye care professionals and their patients, particularly where lower doses of tropicamide and phenylephrine are preferred.
Moreover, Eyenovia is set to present at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting on May 7, 2024. The presentation will discuss a study on Formosa Pharmaceuticals' Active Pharmaceutical Ingredient Nanoparticle Technology (APNT™), which is used in clobetasol propionate ophthalmic suspension 0.05%, approved by the FDA for the treatment of post-operative inflammation and pain.
Eyenovia plans to launch clobetasol later this summer, complementing Mydcombi in the market.
Eyenovia's clobetasol is expected to enter a market estimated to be worth over $1.3 billion annually. The company anticipates that the APNT technology will be incorporated into future products and is optimistic about the potential of the Optejet dispenser to deliver these suspensions.
This news is based on a press release statement from Eyenovia, Inc. and has not been independently verified. Eyenovia has not provided any guidance on the expected financial impact of these developments.
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