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Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of late-stage printed microdose (MAP™) therapies, today provided an update on its expanded manufacturing capabilities and also announced the appointment of Bren Kern as senior vice president of manufacturing and operations.
Redwood City, CA facility
The company today announced that its new manufacturing facility in Redwood City, California is operational. The facility, which is located close to Silicon Valley-based suppliers and customers, will primarily focus on Optejet® manufacturing finishing operations, including loading, labeling and packaging of drugs before the distribution.
“With our Redwood City facility now operational, Eyenovia has in-house manufacturing capabilities to complement our existing contract manufacturing partners,” said Michael Rowe, Chief Operating Officer of Eyenovia. “As we have learned over the past few years, redundancy and additional capacity is the best insurance to ensure that our Optejet products are manufactured and available on time for us and our strategic partners, Bausch+Lomb and Arctic Vision.”
Appointment of Bren Kern as SVP of Manufacturing and Operations
Eyenovia also announced today the appointment of Bren Kern as the company’s senior vice president of manufacturing and operations.
“I am thrilled to join the talented team at Eyenovia,” said Mr. Kern. “By offering pharmacological solutions with a unique delivery mechanism, we believe our products will fundamentally change our view of topical eye treatments. I look forward to contributing to the team and championing our internal manufacturing and engineering operations to help bring these exciting solutions to market.
Mr. Kern has spent his career helping companies transition from research and development entities to large-scale commercial manufacturing organizations. Over the past 20 years he has honed his skills leading product optimization, supporting regulatory approvals (510K and PMA) and establishing cGMP compliant manufacturing solutions worldwide.
Reaffirm VISION-2 deadlines
Eyenovia also reaffirms today its earlier timing guidance for the ongoing VISION-2 Phase 3 trial of MicroLine, its proprietary formulation of pilocarpine for the temporary improvement of near vision (presbyopia). Enrollment in the registration-enabling study is nearing completion, and the company remains on track to release key data in the third quarter of this year.
Recent market research indicates strong interest in Optejet dispensing technology among people with presbyopia, who have never previously needed reading glasses, in the target age group of 40-55. It is estimated to be an addressable market of over 18 million people in the United States alone.
Optejet is unique to MicroLine and is not available with any other presbyopia treatment currently available or in development.