California successfully completedFDAinspection for approval as a commercial manufacturing facility. The Redwood City facility will primarily be used for final assembly, packaging and labeling activities in support
On October 25, 2021, Eyenovia announced that it had received notice from the U.S. Food and Drug Administration (FDA) in the form of a Complete Response Letter (CRL) that MydCombi has been reclassified as a drug-device combination product as part of the agency’s review of the MydCombi ...
Eyenovia announced today results from a Phase IV study of Mydcombi® designed to characterize the lowest deliverable dose for mydriasis (pupil dilation). Mydcombi is the only FDA-approved fixed dose combination of tropicamide a...
Food and Drug Administration (FDA) approval on March 4, 2024, based on clinical results showing nearly nine out of ten patients achieving complete absence of post-surgical pain and six out of ten achieving total absence of inflammation within 15 days post-ocular surgery. Eyenovia acquired the U...
As Eyenovia accelerates its commercial capabilities in 2024 with the expanded launch of MydCombi and the anticipated introduction of APP-13007 (pending FDA approval anticipated in March), MicroPine adds a major late-stage asset in a large market with high unmet medical need; Based ...