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According to Outlook, in the FDA’s recently issued CRL it concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.

We spoke with researchers and industry professionals at the 2023 ASRS meeting in Seattle, Washington. We asked them, "What do you wish patients knew about eye health?" Here's what Michael Ip, MD, Shawn Kavoussi, MD, and Megan Baldwin, PhD, had to say!