February 13, 2024
NEW YORK— Eyenovia, Inc. has announced that the company’s facility in Redwood City, Calif., successfully completed FDA inspection for approval as a commercial manufacturing facility. The Redwood City facility will primarily be used for final assembly, packaging, and labeling activities in support of Mydcombi, the first and only fixed combination of tropicamide and phenylephrine for in-office and pre-surgical pupil dilation utilizing Optejet technology.
Redwood City complements Eyenovia’s manufacturing capabilities in Reno, as well as its contract manufacturer, Coastline International, to produce commercial supply of Mydcombi in the company’s proprietary Optejet dispensing platform.
“The FDA inspection of our Redwood City facility was completed efficiently and with no significant concerns raised on the part of the inspector, clearing the way for us to perform final assembly, packaging, and labeling in support of a broader U.S. launch of Mydcombi,” said Eyenovia’s Chief Operating Officer Bren Kern.
In addition to commercializing Mydcombi, in August 2023, Eyenovia acquired the U.S. commercial rights to APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) from Formosa Pharmaceuticals. APP13007, which is currently under review by the FDA, is a potent steroid being developed to reduce pain and inflammation following ocular surgery. The agency has assigned a Prescription Drug User Fee Act (PDUFA) action date for APP13007 of March 4, 2024.
Eyenovia is also advancing late-stage development of medications in the Optejet device for presbyopia and myopia progression (partnered with Arctic Vision in China and South Korea).
