Hogan Lovells Cadwalader Secures FDA Approval for Outlook Therapeutics' LYTENAVA through Formal Dispute Resolution

"Hogan Lovells Cadwalader advised Outlook Therapeutics in an FDA formal dispute resolution that led to approval of LYTENAVA (bevacizumab-vikg) for neovascular (wet) age-related macular degeneration—the first FDA‑approved ophthalmic bevacizumab formulation for wet AMD in the United States."

Hogan Lovells Cadwalader advised Outlook Therapeutics, Inc. in the U.S. Food and Drug Administration review and formal dispute resolution process concerning LYTENAVA (bevacizumab-vikg). The firm provided regulatory counsel throughout the FDA review, including representing Outlook in a formal dispute resolution before the FDA’s Office of New Drugs. That process culminated in FDA approval of LYTENAVA for the treatment of neovascular (wet) age‑related macular degeneration (nAMD). LYTENAVA is the first and only FDA‑approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the United States. Hogan Lovells Cadwalader represented Outlook Therapeutics, Inc. with a team composed by: partners David Fox and Komal Karnik Nigam and senior associate Eva Marie Schifini.

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Hogan Lovells Cadwalader Secures FDA Approval for Outlook Therapeutics' LYTENAVA through Formal Dispute Resolution

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Hogan Lovells Cadwalader Secures FDA Approval for Outlook Therapeutics' LYTENAVA through Formal Dispute Resolution

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