Eyenovia Inc announced on Monday that the FDA had cleared its pupil-dilating spray for use with the companys unique medication delivery system during eye exams.

The spray is intended to treat mydriasis, or pupil dilatation, during eye exams before cataract surgery or corrective prescriptions. Given its reliance on Eyenovias investigational medication delivery technology Optejet for administration, the US Food and Drug Administration categorized Mydcombi as a drug-device combination product in 2021.

The FDA had previously rejected to approve the spray as a single medicine and had sought more device testing for the Optejet dispenser. The FDA did not require any more clinical trials for Mydcombi.

In a statement, Eyenovias CEO said, "We look forward to introducing Mydcombi to key offices beginning this summer while we bring our internal manufacturing capabilities online for 2024."

(Source: https://health.economictimes.indiatimes.com/news/pharma/us-fda-approves-eyenovias-pupil-dilating-spray/100077984)