On July 24, 2026, Outlook Therapeutics, Inc. announced that the FDA approved LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (known as “nAMD” or “wet AMD”), marking the first FDA-approved ophthalmic formulation of bevacizumab in the United States. According to Outlook, bevacizumab has long been used off label…
On July 8, 2024, Outlook Therapeutics announced it received marketing authorization from UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of wet AMD in the UK. As we previously reported, Outlook Therapeutics received marketing authorization for LYTENAVA™ in the EU on May 28, 2024. With these approvals,…
In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab. On May 22, Sandoz announced that it received marketing authorization from the European Commission for its WYOST® and JUBBONTI® denosumab biosimilars. According to Sandoz, these…
Outlook Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for ONS-5010 / LYTENAVA (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD). There are no FDA-approved ophthalmic formulations of bevacizumab currently…
On August 30, 2022, Outlook Therapeutics, Inc. announced that it has re-submitted its Biologics License Application (BLA) to the FDA for ONS-5010, “an investigational ophthalmic therapy which, if approved, will be branded as LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).” As we previously reported, Outlook…
Outlook Therapeutics announced today that the FDA has requested additional information in order to complete the filing of the company’s BLA for LYTENAVA. LYTENAVA, or ONS-5010, is an ophthalmic intravitreal injection formulation of bevacizumab for the treatment of wet AMD and other retinal diseases. In response to FDA’s request, Outlook…
On July 29, 2021, the American Academy of Ophthalmology (AAO) released a statement urging the Centers for Medicare & Medicaid Services (CMS) to prohibit Insurance companies from requiring ophthalmologists to use new biosimilar drugs as alternatives to Avastin for treatment in eye diseases. The statement alleges that certain large healthcare…
On June 16, 2020, Shanghai Henlius Biotech, Inc. announced that HLX04-mCRC03, a phase 3 clinical trial of bevacizumab biosimilar HLX04, had successfully met its primary endpoint. The study compared the safety, efficacy and immunogenicity of HLX04 and Avastin in combination with oxaliplatin and fluoropyrimidine-based chemotherapy as first-line treatment in patients…