Name: Lytenava (bevacizumab-vikg) in Neovascular age-related macular degeneration: Phase of product development
Published: 2026-09-28T12:24:10-04:00

Regulatory submission: BLA approved July 2026

“Please refer to your biologics license application (BLA) dated and received August 29, 2022, and your amendments, submitted under section 351(a) of the Public Health Service Act for Lytenava (bevacizumab-vikg) injection. We acknowledge receipt of your resubmission dated May 29, 2026, which constituted a complete response to our December 30, 2025, action letter.” (opens the source at this quote in a new tab)
“We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling.” (opens the source at this quote in a new tab)

“Initial U.S. Approval: 2026” (opens the prescribing information at this quote)

Launch: Anticipated before the end of 2026

“Outlook Therapeutics expects to make LYTENAVA™ available to eligible patients in the United States before year-end.” (opens the source at this quote in a new tab)

“The Company continues to advance preparations for the U.S. commercial launch of LYTENAVA, the only FDA-approved ophthalmic bevacizumab for the treatment of wet age-related macular degeneration (wet AMD).” (opens the source at this quote in a new tab)
“Outlook Therapeutics is advancing preparations for the U.S. commercial launch of LYTENAVA, planned before the end of calendar 2026.” (opens the source at this quote in a new tab)

Regulatory history: first Complete Response Letter

“the U.S. Food and Drug Administration (FDA) has issued a CRL to the Company's BLA for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. While the FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, the Agency concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.” (opens the source at this quote in a new tab)
“The FDA accepted Outlook Therapeutics' BLA submission for ONS-5010 to treat wet AMD with an initial PDUFA goal date of August 29, 2023; FDA did not approve the BLA during this review cycle and the Company is working with the FDA to address the issues that have been raised so that the BLA may be re-submitted.” (opens the source at this quote in a new tab)

Regulatory history: NORSE EIGHT trial, second and third Complete Response Letters

“In the fourth quarter of calendar 2023, the Company agreed to conduct an additional adequate and well-controlled clinical trial to support its Biologics License Application (“BLA”) for LYTENAVA. The Company submitted a Special Protocol Assessment (“SPA”) for the NORSE EIGHT study in December 2023, and in January 2024 the U.S. Food and Drug Administration (the “FDA”) agreed that the protocol, if successful, would satisfy the requirement for a second adequate and well-controlled trial. The Company also identified approaches to address the Chemistry, Manufacturing, and Controls (“CMC”) comments in the Complete Response Letter (“CRL”). In November 2024, the Company announced that NORSE EIGHT did not meet the pre-specified non-inferiority endpoint; however, results demonstrated improvements in vision, evidence of biologic activity, and a favorable safety profile, which were further supported by the full week 12 data set. The Company resubmitted the BLA in February 2025. On August 27, 2025, the FDA issued a second CRL citing a single deficiency related to substantial evidence of effectiveness and recommended submission of confirmatory efficacy data, while reaffirming that the NORSE TWO trial met its primary endpoint. Following a Type A meeting in September 2025, the Company resubmitted the BLA on November 3, 2025, and received a third CRL on December 31, 2025.” (opens the source at this quote in a new tab)
“Following receipt of the CRL in December 2025, the Company engaged with the FDA on multiple occasions, including a formal Type A meeting held on March 2, 2026, which led to the submission of a formal dispute resolution meeting request. In April 2026, the meeting with the deciding official was conducted as part of the Company's ongoing efforts to align with the FDA regarding the regulatory pathway for LYTENAVA™ (bevacizumab-vikg).” (opens the source at this quote in a new tab)

Regulatory history: resubmission acceptance and final approval

“the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD), or wet AMD. The Company has been informed that the resubmission is a Class 1 review, with a PDUFA target action date of July 29, 2026.” (opens the source at this quote in a new tab)
“Outlook Therapeutics has initiated pre-launch activities in anticipation of the pending BLA approval.” (opens the source at this quote in a new tab)

“today announced that the U.S. Food and Drug Administration (FDA) has approved LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD), commonly known as wet AMD.” (opens the source at this quote in a new tab)
“The approval establishes LYTENAVA™ as the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the United States.” (opens the source at this quote in a new tab)
“the Company anticipates that the approval will provide LYTENAVA with 12 years of Reference Product Exclusivity under the BPCIA.” (opens the source at this quote in a new tab)

Regulatory history: European Union and United Kingdom approval and launch

“In May 2024 the Company received Marketing Authorization from the European Commission for LYTENAVA (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (“AMD”) in the European Union (“EU”). Additionally, in July 2024 the Company also received marketing authorization for LYTENAVA (bevacizumab gamma) in the United Kingdom (“UK”) from the UK Medicines and Healthcare products Regulatory Agency (“MHRA”). LYTENAVA (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU and UK. In June 2025, the Company launched LYTENAVA commercially in both Germany and the UK, and commenced commercial sales in those countries.” (opens the source at this quote in a new tab)

“In Europe, Outlook Therapeutics continues to expand the commercialization of LYTENAVA in Germany, Austria and the United Kingdom. The Company is also preparing for a planned launch in the Netherlands later in 2026 following its Netherlands submission. In Switzerland, the Company's partner, Mediconsult, is leading regulatory and commercial activities in support of an anticipated launch in 2027.” (opens the source at this quote in a new tab)