# LYTENAVA (bevacizumab-vikg) PDUFA Event: Neovascular age-related macular degeneration

Canonical URL: https://biopharmsignal.com/pdufa-calendar/OTLK/ons-5010-lytenava-wet-amd-review-4

Ticker: OTLK

Company: Outlook

Event date: 2026-07-29

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-07-24

Application type: BLA

Review cycle: 4

FDA approved LYTENAVA for wet AMD. FDA approved LYTENAVA for neovascular age-related macular degeneration, making it the first FDA-approved ophthalmic bevaci...

## Event Timeline

### July 24, 2026 — 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](https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-announces-lytenavatm-fda-approval-first-and)

### June 16, 2026 — 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](https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-announces-fda-acceptance-resubmitted)

### June 1, 2026 — 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](https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-announces-resubmission-biologics-license)

### December 30, 2025 — 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](https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-first-quarter-fiscal-year-2026/)

### November 3, 2025 — Outlook resubmitted the BLA for a third review cycle

Following a September Type A meeting, Outlook resubmitted the BLA and received a December 31, 2025 PDUFA goal date.

[Outlook Therapeutics — 2025 Form 10-K](https://ir.outlooktherapeutics.com/static-files/60746603-27ff-46c8-bd07-c345a61a8547)

### August 28, 2025 — FDA issued the second Complete Response Letter

FDA said the resubmitted BLA could not be approved in its then-current form and identified lack of substantial evidence of effectiveness as the sole deficiency.

[Outlook Therapeutics — Second Complete Response Letter](https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-provides-regulatory-update-us-food-and-drug)

### February 27, 2025 — Outlook resubmitted the BLA for a second review cycle

The resubmission incorporated NORSE EIGHT efficacy and safety data and additional chemistry, manufacturing and controls information requested by FDA.

[Outlook Therapeutics — Third-quarter fiscal 2025 update](https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-financial-results-third-quarter-2)

### August 29, 2023 — FDA issued the initial Complete Response Letter

FDA did not approve the original BLA because of chemistry, manufacturing and controls issues, open observations from pre-approval inspections and insufficient substantial evidence of effectiveness.

[Outlook Therapeutics — Initial BLA review history](https://ir.outlooktherapeutics.com/investor-overview)

## Related Pages

- OTLK PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/OTLK.md

- OTLK company profile: https://biopharmsignal.com/company/OTLK.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-10-06 — Outlook Therapeutics Highlights What the Appointment of New CFO Kevin Lundquist Means for the Company’s Next Chapter in Virtual Investor Discussion: https://biopharmsignal.com/news/OTLK/outlook-therapeutics-highlights-what-the-appointment-of-new-cfo-kevin-lundquist--8e863a17.md

- 2026-10-01 — Outlook Therapeutics Submits HCPCS Level II Application to CMS for Permanent J-Code for LYTENAVA™ (bevacizumab-vikg): https://biopharmsignal.com/news/OTLK/outlook-therapeutics-submits-hcpcs-level-ii-application-to-cms-for-permanent-j-c-287a657b.md

- 2026-09-11 — Outlook Therapeutics Fireside Chat from H.C. Wainwright Conference Now Available On-Demand: https://biopharmsignal.com/news/OTLK/outlook-therapeutics-fireside-chat-from-h-c-wainwright-conference-now-available--710f01ae.md

- 2026-09-10 — Outlook Therapeutics CEO, Bob Jahr, Discusses FDA Approval and Commercial Opportunity for LYTENAVA™ in Virtual Investor CEO Connect Segment: https://biopharmsignal.com/news/OTLK/outlook-therapeutics-ceo-bob-jahr-discusses-fda-approval-and-commercial-opportun-ab32c0ff.md

- 2026-08-27 — Outlook Therapeutics Appoints Kevin Lundquist as Chief Financial Officer as It Prepares for U.S. Commercial Launch of LYTENAVA™: https://biopharmsignal.com/news/OTLK/outlook-therapeutics-appoints-kevin-lundquist-as-chief-financial-officer-as-it-p-bcce914f.md