Outlook Therapeutics Submits Re-filed BLA for LYTENAVA™ for Wet AMD Treatment
ISELIN, N.J., Feb. 28, 2025 – Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pioneering biopharmaceutical company, recently announced the re-submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic product. This product, if approved, will be marketed under the brand name LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).
Background on Wet AMD and Current Treatment Landscape
Wet AMD is a progressive form of age-related macular degeneration, a leading cause of vision loss in older adults. The condition is characterized by the growth of new, abnormal blood vessels under the retina, which leak fluid and protein, leading to damage and vision loss. Current treatments for wet AMD include anti-vascular endothelial growth factor (anti-VEGF) therapies, such as Lucentis® (ranibizumab) and Eylea® (aflibercept), administered as frequent intravitreal injections. These injections can be burdensome for patients due to their frequent administration and associated costs.
About ONS-5010 (LYTENAVA™) and Its Potential Benefits
ONS-5010 is a proposed ophthalmic formulation of bevacizumab, a well-established anti-VEGF therapy, which has shown promise in clinical trials for the treatment of wet AMD. The re-filed BLA submission includes data from the pivotal phase 3 CHALLENGE and CHANCE trials, which demonstrated the non-inferiority of ONS-5010 to Lucentis® in terms of vision gains and safety. If approved, LYTENAVA™ would offer several potential advantages over current treatments:
- Longer dosing interval: LYTENAVA™ could potentially reduce the need for frequent intravitreal injections, offering greater convenience for patients.
- Lower cost: As an ophthalmic formulation, LYTENAVA™ may be less expensive than Lucentis® or Eylea®, making it a more accessible treatment option for patients.
- Reduced injection-related risks: Eliminating the need for frequent intravitreal injections could help reduce the risks associated with the injection procedure, such as infection, endophthalmitis, and retinal detachment.
Impact on Individuals and the World
For individuals with wet AMD, the approval of LYTENAVA™ could mean improved convenience, reduced treatment costs, and a safer alternative to current intravitreal injections. The availability of a longer-lasting, cost-effective treatment option could also have a significant impact on the global wet AMD patient population:
- Improved patient access: With a longer dosing interval and potentially lower cost, LYTENAVA™ could make wet AMD treatment more accessible to a larger number of patients, especially in countries where cost is a significant barrier to care.
- Reduced burden on healthcare systems: By reducing the frequency of intravitreal injections, healthcare systems could save on administration costs, allowing for the allocation of resources to other critical areas.
- Advancements in AMD research: The success of LYTENAVA™ could encourage further research into alternative treatment modalities for wet AMD, potentially leading to even more effective and convenient therapies.
Conclusion
Outlook Therapeutics’ re-submission of the BLA for LYTENAVA™ marks an important step forward in the treatment of wet age-related macular degeneration. If approved, LYTENAVA™ could offer patients a more convenient, cost-effective, and safer alternative to current intravitreal anti-VEGF therapies. The potential benefits of this investigational ophthalmic product extend far beyond individual patients, with the potential to significantly impact healthcare systems and advance AMD research. Stay tuned for updates on the FDA’s decision regarding the approval of LYTENAVA™.
