(Reuters) – Eyenovia Inc said on Monday the U.S. Food and Drug Administration (FDA) had approved its pupil-dilating spray to be used with the company’s proprietary drug delivery device during eye examinations.
The spray is indicated for mydriasis, or pupil dilation, for eye examinations carried out before cataract surgery or corrective prescriptions.
The U.S. health regulator had reclassified the drug, Mydcombi, as a drug-device combination product in 2021, given its dependence on Eyenovia’s experimental drug delivery device Optejet for administration.
The agency had declined to approve the spray in its then-form as a standalone drug and requested additional device testing for the Optejet dispenser. The FDA had not requested any additional clinical work for Mydcombi drug.
“We look forward to introducing Mydcombi to key offices beginning this summer while we bring our internal manufacturing capabilities on-line for 2024,” Michael Rowe, chief executive officer of Eyenovia, said in a statement.
(Reporting by Aditya Samal and Mariam Sunny in Bengaluru; Editing by Subhranshu Sahu)
