Mixed Results for Roche’s Vamikibart in Phase III Uveitic Macular Edema Trials

Roche presented pivotal Phase III trial data for vamikibart, a non-steroid anti-IL-6 therapy, in uveitic macular edema (UME), a vision-threatening retinal condition2 3.

In the MEERKAT trial, vamikibart met its primary endpoint:
36.9% of the 1 mg dose group achieved a ≥15-letter gain in best corrected visual acuity (BCVA) at week 16, showing statistically significant superiority over sham (P=0.0008)2 3.

In the SANDCAT trial, though vamikibart groups showed improvement in BCVA, the primary endpoint did not reach nominal statistical significance (1 mg dose:
+10.9%, P=0.0699)2 4.

Both trials showed rapid improvements in mean BCVA and central subfield thickness (CST) compared to sham, indicating consistent clinical benefits1 2 3.

Vamikibart was generally well tolerated with few treatment-related ocular adverse events; common events (>5%) included conjunctival hemorrhage and increased intraocular pressure, and no cases of retinal occlusive vasculitis were reported1 3 4.

Differences in primary outcomes between the trials may have resulted from variability in BCVA measurements, patient baseline characteristics, and concomitant medications; further analyses are ongoing1 2.

Vamikibart may offer a promising new targeted treatment for UME beyond traditional steroid therapy, addressing inflammation by inhibiting IL-6 signaling3 8.

The new data from both trials were presented in October 20252 5 6.