Outlook Therapeutics® Announces SMC Recommendation of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD

ISELIN, N.J., JUNE 10 2025 —Outlook Therapeutics, Inc. (Nasdaq: OTLK), today announced the Scottish Medicines Consortium (SMC) approval of LYTENAVA™ (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD). LYTENAVA™ (bevacizumab gamma) is the first and only licensed ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the European Union (EU) and the United Kingdom (UK) and has an initial 10 years of market exclusivity.

“Receiving the SMC recommendation of LYTENAVA™ (bevacizumab gamma) for adult patients with wet AMD is a significant milestone for our company and a testament to our commitment to improving patient outcomes,” commented Jedd Comiskey, Senior Vice President, Head of Europe, Outlook Therapeutics. “This approval ensures that patients in Scotland will have access to an additional treatment option. Our focus now is to work closely with healthcare providers to ensure a smooth rollout and to continue our mission of advancing healthcare solutions that make a real difference in people's lives.”

The positive SMC recommendation follows the news from Outlook Therapeutics earlier this month, who announced that LYTENAVA™ is now commercially available in the UK for the treatment of wet AMD. The decision was based on the results from Outlook Therapeutics’ wet AMD clinical program for ONS-5010 / LYTENAVA™, which consists of three completed registration clinical trials - NORSE ONE, NORSE TWO and NORSE THREE, as well as studies and peer reviewed literature substituting or supporting certain tests and studies.

Dr. Manjit Mehat, Senior Clinical Lecturer at The University of Edinburgh, NHS Consultant Ophthalmologist, and Vision Scotland Eye Surgeon noted, “This decision marks a significant step forward in ongoing efforts to provide the best possible care for patients needing licensed anti-VEGF treatments to control their wet AMD.”

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 Europe and, if approved, in the United States.

About LYTENAVA™ (bevacizumab gamma)

LYTENAVA™, an ophthalmic formulation of bevacizumab, is a recombinant humanised monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralises 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 the EU 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.