AAO 2026: Vamikibart shows sustained gains in uveitic macular edema as FDA accepts BLA

At this year’s American Academy of Ophthalmology 2026 Annual Meeting (AAO 2026) in New Orleans, LA, Roche presented 52 week data from the phase III MEERKAT and SANDCAT studies evaluating investigational vamikibart compared with a sham procedure that mimics intravitreal (IVT) injections in adults with uveitic macular edema (UME). According to the company, data continues to support the potential for “rapid and sustained improvements in vision and reductions in macular thickness” with vamikibart treatment.^1,2

In addition to the results, Roche also announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for vamikibart for the treatment of UME—which is based on results from the 2 trials. The FDA is expected to decide on approval by July 2027.¹

Vamikibart is an investigational monoclonal antibody that has been specifically engineered for IVT administration. It targets interleukin-6 (IL-6), a key cytokine in the inflammatory pathway in UME. In the phase 1 DOVETAIL trial, vamikibart provided rapid vision improvements and resolution of macular edema in people with UME—resulting in the commencement of MEERKAT and SANDCAT.

MEERKAT (NCT05642312) and SANDCAT (NCT05642325) are 2 identical global, parallel, multicenter, randomized, double-masked, sham comparator-controlled, 52-week trials of intravitreal (IVT) vamikibart in uveitic macular edema (UME). In both trials, patients were randomized to receive treatment every 4 weeks with either 0.25 mg vamikibart, 1 mg vamikibart or sham IVT injection, for up to 16 weeks, followed by PRN treatment through week 52. The primary endpoint of both trials was the proportion of participants with a 15 letter or more improvement from baseline in best corrected visual acuity (BCVA) at week 16, with key secondary endpoints including the average change from baseline in BCVA and CST at week 16.¹

Nisha Acharya, MD, MD, distinguished professor of ophthalmology at UCSF and director of the uveitis and ocular inflammatory disease service, commented in a press release from the company, “vamikibart is the first non-steroid targeted therapy to demonstrate meaningful and sustained visual and anatomical improvements in people with UME, offering a potential new treatment option that directly targets the inflammation driving this sight-threatening condition.”

Data showed that at 52 weeks, a numerically higher proportion of vamikibart-treated patients achieved vision gains compared to sham treatment on the primary endpoint in both MEERKAT and SANDCAT. Additionally, key secondary endpoints showed benefit was maintained, with sustained improvements in average change from baseline in best corrected visual acuity (BCVA) and average change from baseline in central subfield thickness (CST). Of patients treated, approximately two-thirds of eligible patients required no retreatment after 16 weeks, while the majority of those who did required only 1 additional injection.

Earlier this year at ARVO, Eduardo Uchiyama, MD, and colleagues presented week 16 outcomes from MEERKAT and SANDCAT.³

In MEERKAT and SANDCAT, respectively, mean CST change from baseline was −187.5/−209.7 μm with vamikibart 0.25 mg and −196.1/−194.7 μm with vamikibart 1.0 mg, versus −58.5/−43.5 μm with sham. The proportion of patients achieving UME resolution (CST below 325 μm) was 56.7/63.3% with 0.25 mg and 61.2/57.3% with 1.0 mg, versus 16.3/18.0% with sham. The proportion of patients achieving a ≥15-letter improvement in BCVA was 26.1/34.0% with 0.25 mg and 43.2/24.2% with 1.0 mg, versus 6.3/13.3% with sham. Mean BCVA change from baseline was +9.6/+11.9 letters with 0.25 mg and +12.8/+9.2 letters with 1.0 mg, versus +3.5/+5.0 letters with sham.

References:

1. Roche presents new Phase III one-year data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss. Roche. Published October 9, 2026. Accessed October 13, 2026. https://www.roche.com/media/releases/med-cor-2026-10-10

2. Acharya N, et al. Vamikibart for Uveitic Macular Edema: Week 52 Efficacy and Safety Results From the Phase 3 MEERKAT and SANDCAT Trials. Presented at: the American Academy of Ophthalmology Annual Meeting (AAO 2026); 2026 October 10; New Orleans, Louisiana, United States.

3. Stevenson S. ARVO 2026: Vamikibart trials advance IL-6 inhibition in retinal disease. Ophthalmology Times. Published May 6, 2026. Accessed October 13, 2026. https://www.ophthalmologytimes.com/view/arvo-2026-vamikibart-trials-advance-il-6-inhibition-in-retinal-disease