Genentech, a member of the Roche Group, has unveiled results from two pivotal Phase III trials—MEERKAT and SANDCAT—evaluating the investigational drug vamikibart for uveitic macular edema (UME), a sight-threatening complication of uveitis. As reported by Business Wire, the studies compared two doses of vamikibart (0.25 mg and 1 mg) against a sham procedure mimicking intravitreal injections.
Key Findings:
- Vamikibart demonstrated rapid improvements in vision and reductions in macular thickness, with statistically significant superiority over sham in the MEERKAT trial.
- Both trials showed clinically meaningful gains in best corrected visual acuity (BCVA) and central subfield thickness (CST), supporting vamikibart’s efficacy.
- The drug was well tolerated, with a low incidence of ocular adverse events and no cases of retinal occlusive vasculitis.
Clinical Significance: Current UME treatments rely heavily on corticosteroids, which carry risks such as elevated intraocular pressure, glaucoma, and cataracts. Vamikibart, a locally injectable non-steroidal monoclonal antibody targeting IL-6, offers a promising alternative with fewer side effects.
Study Design: MEERKAT and SANDCAT were identical, global, double-masked, sham-controlled trials involving treatment every four weeks for 16 weeks. The primary endpoint was a ≥15-letter improvement in BCVA, with secondary endpoints assessing average changes in BCVA and CST.
About UME: Though rare, UME is a leading cause of vision loss in uveitis patients and contributes significantly to blindness worldwide. It affects quality of life and daily functioning, and current therapies have notable limitations.
Next Steps: Genentech plans to engage with regulatory authorities to discuss vamikibart’s potential as a first-in-class treatment for UME. The drug holds orphan designation in both the U.S. and EU.
For more information, visit Genentech’s website.
