FDA approves Eyenovia’s Redwood City commercial manufacturing facility

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Eyenovia Inc announced its facility in Redwood City, California successfully completed FDA inspection for approval as a commercial manufacturing facility.

According to a news release from Eyenovia,¹ its 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.

Michael Rowe, Eyenovia’s CEO, pointed out in the news release the inspection went off without a hitch.

“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,” Rowe said in the news release. “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.”

Moreover, Eyenovia noted in its news release the Redwood City site complements its 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.

“I am very pleased with the results of the audit and commend our manufacturing, engineering, quality and regulatory staff for their diligence and work to make this a reality,” Bren Kern, the company’s COO, added in the news release. “The team had been working tirelessly in preparation for this key milestone and their efforts bore out in the result.”

Reference:

1. Eyenovia Announces FDA Approval of Redwood City as Commercial Manufacturing Facility | Eyenovia Inc. Eyenovia Inc. Published 2024. Accessed February 13, 2024. https://ir.eyenovia.com/news-releases/news-release-details/eyenovia-announces-fda-approval-redwood-city-commercial