Genentech, a member of the Roche Group, announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for faricimab-svoa (Vabysmo) to treat macular edema following retinal vein occlusion (RVO).
What’s the difference between a BLA and sBLA?
A Biologics License Application (BLA) is an official request to the FDA for permission to introduce or deliver a biologic product through interstate commerce, linking back to the original paperwork submitted to the government from clinical studies.
An sBLA may be considered a follow-up to the original BLA as a new treatment indication and more extended data to support the claim.
If the sBLA is for the same indication, however, the new data could indicate a change in treatment protocol.
Give me a refresh on Vabysmo.
Vabysmo is the first bispecific antibody that was FDA approved (in 2022) to be administered via intravitreal injection into the eye for patients with neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).
It is also currently approved in 60 countries.
Click here for a rundown.
Didn’t we just hear about it?
Yes! Just 2 weeks ago Genentech reported Vabysmo superiority results from a post-hoc analysis—based on the phase 3 trials TENAYA (NCT03823287) and LUCERNE (NCT03823300) for wet AMD as well as YOSEMITE (NCT03622580) and RHINE (NCT03622593) for DME—comparing Vabysmo to aflibercept for drying retinal fluid.
So what clinical data is this new approval based on?
The sBLA is based on positive data from two ongoing randomized, multicenter, double-masked, global phase 3 trials—BALATON (NCT04740905) and COMINO (NCT04740931)—that also compared the safety and efficacy of Vabysmo versus aflibercept over the course of 6 months.
The BALATON study has enrolled 533 patients with branch RVO, while the COMINO includes 729 patients with central RVO or hemiretinal vein occlusion.
Findings so far?
Both trials have met their primary endpoint of change in best-corrected visual acuity (BCVA) from baseline at 24 weeks as well as secondary endpoint of change in central subfield thickness (CST) from baseline over time up to 24 weeks.
This data is consistent with previous clinical trials.
Significance?
If approved by the FDA, this would be the third indication for Vabysmo; it would also become the first bispecific antibody available for blinding retinal conditions.
What’s next?
Based on sBLA acceptance, Genentech can introduce Vabysmo into interstate commerce and market it for its approved patients. Stay tuned for further updates!