Swiss pharmaceutical giant Roche (SWX: ROG) announced last week that it has received an indication extension approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Vabysmo (faricimab) to treat macular edema following retinal vein occlusion (RVO). This approval broadens the therapeutic applications of Vabysmo, which was previously registered in the US for neovascular or wet age-related macular degeneration (nAMD) and diabetic macular edema (DME).
Clinical Trial Results and FDA Decision
The FDA’s decision is supported by positive results from two late-stage trials that demonstrated rapid and robust drying of retinal fluid. The trials also met the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept, a standard of care treatment. These outcomes highlight the potential of Vabysmo to provide a new treatment option for patients suffering from macular edema secondary to RVO.
Drug Label Update and Safety Information
In conjunction with the approval, Roche updated the drug label for Vabysmo to include warnings about rare cases of retinal vasculitis and retinal vascular occlusion. This update ensures that healthcare providers and patients are fully informed about the potential risks associated with the use of Vabysmo, aligning with Roche’s commitment to patient safety and transparency.
Conclusion
The expanded indication for Vabysmo marks a significant milestone for Roche, as it continues to leverage its innovative bispecific antibody technology to address unmet medical needs in ophthalmology. With this approval, Roche reinforces its position as a leader in developing treatments for retinal diseases, offering hope to patients with limited treatment options.-Fineline Info & Tech
