On 4th try, Outlook scores FDA nod for reformulated version of Roche's Avastin for AMD

Outlook Therapeutics secured FDA approval for Lytenava, a purpose-built ophthalmic formulation of bevacizumab for wet AMD, after three rejections and a successful formal dispute resolution appeal. The drug enters an $8.5 billion U.S. market dominated by Regeneron's Eylea and Roche's Vabysmo, with 12 years of reference product exclusivity under BPCIA.

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