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BUZZ-Outlook Therapeutics plunges after FDA rejects eye drug for third time

Reuters
01/02
BUZZ-Outlook <a href="https://laohu8.com/S/LENZ">Therapeutics</a> plunges after FDA rejects eye drug for third time

** Shares of Outlook Therapeutics OTLK.O plunge 59.6% to 64 cents premarket

** U.S. FDA declines to approve co's Lytenava for wet age-related macular degeneration, citing lack of confirmatory evidence of efficacy

** Decision marks third rejection after earlier refusals in 2023 and Aug 2025

** Lytenava, an eye disease-specific adaptation of bevacizumab, failed to match Roche's ROG.S Lucentis in key trial

** Drug already approved in EU and UK; FDA has not indicated what type of confirmatory evidence would be acceptable

** OTLK down 16.4% in 2025

(Reporting by Tharuniyaa Lakshmi in Bengaluru)

((tharuniyaa@thomsonreuters.com))

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