Eyenovia announces FDA approval of Redwood City as manufacturing facility

Eyenovia announced that the company’s facility in Redwood City, California 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. “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,” stated Michael Rowe, Eyenovia’s Chief Executive Officer. “With Redwood City and Reno now online and operational, we have the capacity to manufacture both commercial product as well as clinical supply in support of our ongoing CHAPERONE clinical trial for pediatric progressive myopia as well as initial testing of other product candidates that leverage our Optejet technology.”