Outlook Therapeutics announced today that the FDA has requested additional information in order to complete the filing of the company’s BLA for LYTENAVA.  LYTENAVA, or ONS-5010, is an ophthalmic intravitreal injection formulation of bevacizumab for the treatment of wet AMD and other retinal diseases.  In response to FDA’s request, Outlook has voluntarily withdrawn its BLA and plans to resubmit a revised version by September 2022.

There is currently no approved ophthalmic formulation of bevacizumab.  Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, commented, “We remain confident in ONS-5010 and its potential to be the first FDA-approved ophthalmic formulation of bevacizumab that avoids the public health risk to patients of off-label treatment of bevacizumab that was never approved for any ophthalmic indications.”

[View source.]