- LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the European Union (EU) and United Kingdom (UK)
- 2.8 million injections of repackaged off-label bevacizumab in Europe each year1
ISELIN, NJ, June 02, 2025 (GLOBE NEWSWIRE) — Outlook Therapeutics, Inc. (Nasdaq: Otlk), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that LYTENAVA™ (bevacizumab gamma) is now commercially available in Germany and the UK for the treatment of wet age-related macular degeneration (wet AMD). LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the European Union and UK.
“We are excited to have launched LYTENAVA™ (bevacizumab gamma) for patients with wet AMD in Germany and the UK. I would like to extend sincere gratitude to the Outlook team and our partners for their commitment and dedication that helped to get us to this major milestone. Going forward, we remain laser focused on ensuring success in Germany and the UK as well as preparing for additional launches across the region later this year and throughout 2026,” commented Jedd Comiskey, Senior Vice President, Head of Europe at Outlook Therapeutics.
Off-label repackaged bevacizumab is one of the most frequently used first-line anti-VEGF treatments in Europe (approximately 2.8 million injections annually) and the United States (approximately 2.7 million injections annually) for the treatment of retinal diseases. ONS-5010/LYTENAVA™ has potential to mitigate certain risks associated with the current off-label use of repackaged bevacizumab.
Outlook Therapeutics has entered into a strategic collaboration with Cencora (formerly AmerisourceBergen) to support the commercial launch of LYTENAVA™ globally following regulatory approvals. The collaboration and integrated approach is designed to support market access and efficient distribution of LYTENAVA™ to benefit all stakeholders, including retina specialists, providers and patients in certain European markets and, if approved, in the United States.
About ONS-5010 / LYTENAVAS
ONS-5010 / LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. Lytenava ™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD.
In the United States, ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is investigational. In certain European Union Member States ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold.
Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) to enhance the standard of care for bevacizumab for the treatment of retina diseases. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD. In the United States, ONS-5010/LYTENAVA™ is investigational, and a BLA has been resubmitted to the FDA. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “expect,” “may,” “plan,” “potential,” “will,” or “would” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, the success of Outlook Therapeutics’ commercial launch of LYTENAVA™ in Germany and the UK, Outlook Therapeutics’ plans for commercial launch of LYTENAVA™ in additional countries in the EU, Outlook Therapeutics’ commercialization strategy, the market opportunity for ONS-5010/LYTENAVA™, expectations concerning the therapeutic potential of LYTENAVA™ as a treatment of wet AMD, expectations concerning the relationship with Cencora and the benefits and potential expansion thereof, expectations concerning decisions of regulatory bodies and the timing thereof, ONS-5010/LYTENAVA™’s potential as the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal indications, including wet AMD, in the United States and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, unanticipated or greater than anticipated impacts or delays due to macroeconomic and geopolitical conditions (including the long-term impacts of ongoing overseas conflicts, tariffs and trade tensions, fluctuations in inflation and interest rates and other economic uncertainty), as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, and future quarterly reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, high interest rates, inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.
Investor Inquiries:
Jenene Thomas
Chief Executive Officer
Jtc team, llc
T: 908.824.0775
[email protected]
Media Inquiries:
Ellie Blundell
Senior Account Executive
Hanover Communications
T: +44 7738 832195
[email protected]
1 (Citeline (2023), Global Data (2023) and Market Scope (2022); ASRS 2024 Membership Survey Presented at ASRS NY 2022; Market Scope 2024 US Retina Quarterly Updates; GlobalData: Age-Related Macular Degeneration: Global Drug Forecast and Market Analysis to 2028 (April 2020)
LYTENAVA™ Approved for wet AMD in Europe: An Expert weighs In
Keywords: Wet AMD, LYTENAVA, Bevacizumab, Outlook Therapeutics, Age-Related Macular degeneration, Eye Treatment, Europe
Time.news recently spotlighted the launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK by Outlook Therapeutics, marking a significant milestone in the treatment of wet age-related macular degeneration (wet AMD).This is the first and only approved ophthalmic formulation of bevacizumab in the EU and the UK. To delve deeper into the implications of this growth, Time.news spoke with Dr. Anya Sharma, a leading ophthalmologist specializing in retinal diseases.
Time.news: Dr. Sharma, thank you for joining us. LYTENAVA™’s approval seems like a big deal. Can you explain to our readers why this is such an vital development for wet AMD treatment?
Dr. Sharma: absolutely.What makes this significant is that LYTENAVA™ is the first approved specifically formulated ophthalmic bevacizumab. For years, ophthalmologists in Europe and the US have been using bevacizumab to treat wet AMD, but it’s been an off-label use of a repackaged drug originally intended for intravenous cancer treatment. this meant potential variability in compounding and sterility concerns. LYTENAVA™ eliminates some of those concerns.
Time.news: The press release mentions that approximately 2.8 million injections of repackaged off-label bevacizumab are administered in Europe each year. What are the potential risks associated with this off-label use, and how does LYTENAVA™ address them?
Dr.Sharma: With off-label use, there’s always the inherent risk associated with medications not specifically designed and manufactured for intraocular injection. Variations in compounding procedures could lead to inconsistent dosages or, more seriously, contamination that can cause severe eye infections.LYTENAVA™,as an approved ophthalmic formulation,adheres to stricter quality control standards throughout the manufacturing process specifically for the eye.It should mitigate some of the risks of infection and inconsistent dosing.
Time.news: Outlook Therapeutics emphasizes that LYTENAVA™ has the “potential to mitigate certain risks” of off-label bevacizumab. Could you elaborate on what those risks are?
Dr. Sharma: Beyond the compounding and sterility issues,an approved ophthalmic formulation means that the manufacturer,Outlook Therapeutics in this case,is responsible for the quality,efficacy,and safety profile specifically for the eye. This includes factors like particulate matter control, endotoxin levels, and ensuring patient safety, meeting regulatory agency standards and pharmacovigilence responsibilities.
Time.news: The commercial launch is initially focused on Germany and the UK. What is the timeline for potential availability in other European countries and the US?
Dr. Sharma: According to the article, Outlook Therapeutics plans additional launches across the region later this year and throughout 2026. As for the US, LYTENAVA™ (ONS-5010) is still investigational, and the company has resubmitted a BLA (Biologics License Application) to the FDA. If approved in the US, it could be a game-changer, offering a regulated choice to the current off-label use.
Time.news: Could you briefly explain how bevacizumab works to treat wet AMD?
Dr. Sharma: Certainly. Wet AMD is characterized by the abnormal growth of new blood vessels in the retina. These vessels leak fluid, causing blurry vision and potential vision loss.Bevacizumab is a VEGF (vascular Endothelial Growth Factor) inhibitor. It binds to VEGF, a protein that stimulates blood vessel growth, effectively blocking it and reducing the formation of those leaky vessels.
Time.news: What advice would you give to patients currently undergoing wet AMD treatment, given the approval of LYTENAVA™ in Europe?
Dr. Sharma: My advice would be to have an open and informed conversation with your ophthalmologist. Discuss the potential benefits and risks of switching to LYTENAVA™ compared to their current treatment. Factors to consider include the availability of LYTENAVA™ in your respective region, the cost implications, and your individual medical history.
Time.news: what are the potential long-term implications of having an approved ophthalmic bevacizumab formulation like LYTENAVA™ available?
Dr. Sharma: I believe this is a positive step forward. By providing a regulated, specifically formulated medication for wet AMD, we are addressing some of the limitations and potential risks associated with off-label use and could lead to fewer complications overall.Having a safe and effective medication to combat vision loss is vital for improved patient wellbeing and outcomes.
Time.news: Dr. Sharma, thank you for providing such valuable insights into this important development in wet AMD treatment. Your expertise is greatly appreciated.
