Outlook Therapeutics Announces Regulatory Approval of Bevacizumab Ophthalmic Formulation in EU and UK for Wet Age-Related Macular Degeneration
ISELIN, N.J., January 22, 2025 – Outlook Therapeutics, Inc., a leading biopharmaceutical company, is thrilled to announce that it has secured regulatory approval from the European Union (EU) and the United Kingdom (UK) for the use of its ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD). This marks a significant milestone for Outlook Therapeutics as it brings a new and innovative treatment option to patients suffering from this debilitating condition.
Background on Wet AMD and Bevacizumab
Age-related macular degeneration (AMD) is a progressive disease that affects the macula, a small spot near the center of the retina, which is responsible for sharp, central vision, necessary for reading, driving, and recognizing faces. Wet AMD is a more severe form of the disease, characterized by the growth of new, abnormal blood vessels under the retina, which can leak fluid and blood, causing damage to the macula and vision loss. Bevacizumab is a monoclonal antibody that inhibits the activity of vascular endothelial growth factor (VEGF), a protein that plays a key role in the development of new blood vessels in wet AMD.
Regulatory Approval in EU and UK
The EU and UK regulatory agencies, the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA), respectively, have granted marketing authorization for Outlook Therapeutics’ bevacizumab ophthalmic formulation, marketed under the brand name YEVAMUS® (bevacizumab injection for intravitreal use). This approval is based on data from the pivotal Phase 3 CHANGE trial, which demonstrated the safety and efficacy of YEVAMUS® in improving visual acuity and anatomical outcomes in patients with wet AMD.
Impact on Patients
For millions of patients with wet AMD, the approval of YEVAMUS® represents a new hope for preserving and improving their vision. Wet AMD can cause significant vision loss, and current treatments can be costly, invasive, and require frequent injections. The availability of an ophthalmic formulation of bevacizumab will offer patients a more convenient and less invasive treatment option, potentially reducing the burden of frequent injections and improving overall patient experience.
Impact on the World
The approval of YEVAMUS® in the EU and UK is not only a victory for Outlook Therapeutics and its patients but also for the global healthcare community. Age-related macular degeneration is a leading cause of vision loss worldwide, and the availability of a more convenient and less invasive treatment option will have a significant impact on the lives of millions of patients. Furthermore, this approval sets the stage for potential regulatory approvals in other regions, including the United States, further expanding the reach of this innovative treatment.
Conclusion
Outlook Therapeutics’ regulatory approval of the ophthalmic formulation of bevacizumab for the treatment of wet AMD marks a major milestone in the fight against vision loss due to this debilitating condition. The convenience and less invasive nature of this treatment option will undoubtedly improve the lives of millions of patients, and its potential global reach is truly exciting. As we move forward, we can look forward to continued advancements in the field of ophthalmology and the development of new and innovative treatments for various eye conditions.
- Outlook Therapeutics secures regulatory approval for ophthalmic formulation of bevacizumab in EU and UK for wet AMD
- Bevacizumab is a monoclonal antibody that inhibits VEGF, a protein involved in the development of new blood vessels in wet AMD
- YEVAMUS®, the brand name for the bevacizumab ophthalmic formulation, is a more convenient and less invasive treatment option
- Approval based on data from the pivotal Phase 3 CHANGE trial
- Impact on patients: potential reduction in burden of frequent injections and improved overall patient experience
- Impact on the world: potential for global reach and continued advancements in ophthalmology
