After its eye disease antibody flopped in an FDA-requested clinical trial in late November, Outlook Therapeutics is laying off 23% of staff.
The move, which comes after an internal strategic review, is meant to streamline operations and save the company $1.4 million annually, according to a Dec. 13 release.
The New Jersey biotech ran the NORSE EIGHT trial at the behest of the FDA after the agency rejected its Lytenava (bevacizumab) for the treatment of wet age-related macular degeneration (AMD) last year. That trial missed its primary endpoint, with the Outlook drug failing to top or match Roche’s Lucentis as measured by patients' performance on the best corrected visual acuity (BCVA) eye test.
Despite the result, Outlook said it still planned to submit the drug for FDA approval, noting the drug "demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety profile."
“We remain steadfast in our belief in the potential of ONS-5010/Lytenava to meet the global needs of retina specialists, patients and payers and are dedicated to advancing our regulatory and commercial efforts,” Outlook’s chief financial officer and interim CEO Lawrence Kenyon said in the November release.
With Lytenava, Outlook is gambling on there being a market for an on-label bevacizumab for eye diseases. The drug debuted as Avastin from Roche and is used to treat various forms of cancer. But off-label use of Avastin to treat wet AMD spans decades, and Outlook is advancing the first ophthalmic formulation of the medicine.
Lytenava garnered marketing authorization from the European Commission for wet AMD in May. Outlook is aiming to launch Lytenava in Europe in the first half of 2025, the company said in the Dec. 13 release.