LYTENAVA (bevacizumab-vikg)
Neovascular age-related macular degeneration · Patients with neovascular age-related macular degeneration, commonly known as wet AMD
OTLK · Outlook
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8 件のマイルストーンFDA approved LYTENAVA for wet AMD
FDA approved LYTENAVA for neovascular age-related macular degeneration, making it the first FDA-approved ophthalmic bevacizumab developed specifically for use in the eye. The approval occurred before the July 29 PDUFA date.
Outlook Therapeutics — LYTENAVA FDA approval↗FDA accepted the fourth-cycle resubmission
FDA acknowledged the resubmitted BLA as a Class 1 review and assigned a July 29, 2026 PDUFA target action date.
Outlook Therapeutics — BLA acceptance and July 29 PDUFA date↗Outlook resubmitted the BLA after a successful appeal
Outlook resubmitted the application after the FDA Office of New Drugs concluded on appeal that substantial evidence of effectiveness had been established and that an additional clinical trial was not required.
Outlook Therapeutics — BLA resubmission after successful appeal↗FDA issued the third Complete Response Letter
FDA again declined to approve the application, identifying a single deficiency related to substantial evidence of effectiveness and recommending additional confirmatory evidence.
Outlook Therapeutics — First-quarter 2026 regulatory update↗関連ニュース
Outlook Therapeutics Reports Third Quarter Fiscal Year 2026 Financial Results and Provides Business Update Highlighting FDA Approval of LYTENAVA™
2026年8月13日Outlook Therapeutics Announces Pricing of $55.0 Million Public Offering of Common Stock and Warrants
2026年8月12日Outlook Therapeutics Announces Proposed Public Offering of Common Stock and Warrants
2026年8月6日Outlook Therapeutics to Report Third Quarter Fiscal Year 2026 Financial Results and Host a Corporate Update Conference Call and Webcast on August 14, 2026
2026年7月24日Outlook Therapeutics Announces LYTENAVA™ FDA Approval as the First and Only FDA-Approved Ophthalmic Bevacizumab for the Treatment of Wet AMD