Outlook Therapeutics Granted European Authorization for Lytenava for Wet AMD Treatment

Outlook Therapeutics has achieved a significant milestone with the European Commission granting Marketing Authorization for Lytenava (bevacizumab gamma), an innovative ophthalmic formulation designed for the treatment of wet AMD (Age-related Macular Degeneration).

This approval marks a pivotal moment as Lytenava becomes the first and only authorized ophthalmic formulation of bevacizumab sanctioned for wet AMD treatment within the European Union (EU).

Comprehensive Application Process and Clinical Data Support

The authorization process was facilitated through a comprehensive application leveraging Article 8.3 of Directive 2001/83/EC. It was supported by robust clinical data stemming from Outlook’s wet AMD clinical program, which encompassed three pivotal registration trials—NORSE ONE, NORSE TWO, and NORSE THREE. Additionally, the application drew upon supplementary studies and peer-reviewed literature to fortify and augment the evidential basis, as highlighted by Outlook.

Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, expressed elation in a company press release, stating, "This is a landmark milestone for us. We are extremely pleased to receive Marketing Authorization for Lytenava (bevacizumab gamma) in the EU and are moving toward our potential first commercial launch in an EU member state in the first calendar quarter of 2025." Trenary underscored the immense potential of the EU market for wet AMD treatments and extended gratitude to stakeholders involved in the rigorous research, development, and regulatory endeavors that paved the way for this approval.

Market Exclusivity and Expansion

The Marketing Authorization conferred by the European Commission affords Outlook a 10-year period of market exclusivity for Lytenava within the EU. Moreover, the authorization extends automatically to encompass all 27 EU Member States and, within a month, will extend to include Iceland, Norway, and Liechtenstein.

In anticipation of the impending commercial launch, Outlook has forged a strategic collaboration with Cencora (formerly AmerisourceBergen). This collaboration is designed to furnish comprehensive support for the global rollout of Lytenava subsequent to regulatory approvals. In Europe, Cencora will play a pivotal role in the commercialization process, offering a spectrum of services ranging from pharmacovigilance and regulatory affairs to market access support and distribution logistics. The integrated approach aims to optimize market penetration and streamline the distribution network for Lytenava.

Meanwhile, in the United States, Outlook's counterpart formulation, ONS-5010/Lytenava, is undergoing evaluation in a continuing non-inferiority study for wet AMD treatment.

About Wet AMD

Wet AMD is a progressive eye condition and a leading cause of severe vision loss among individuals over the age of 50. It occurs when abnormal blood vessels behind the retina start to grow beneath the macula, a crucial part of the retina responsible for central vision. These abnormal blood vessels leak fluid and blood, causing damage to the macula and leading to distorted or blurred vision. If left untreated, wet AMD can result in rapid and severe vision loss, impacting daily activities such as reading, driving, and recognizing faces.

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