Roche has reported one-year results from the Phase III MEERKAT and SANDCAT studies of investigational vamikibart, showing sustained improvements in vision and reductions in macular thickness (swelling in the back of the eye due to retinal fluid) in patients with uveitic macular edema (UME).
The findings were presented at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting in New Orleans, Louisiana.
The studies evaluated vamikibart against a sham procedure designed to mimic intravitreal (IVT) injections. Across both trials, patients treated with vamikibart showed sustained visual and anatomical improvements through Week 52.
Roche has also announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for vamikibart for the treatment of UME, based on the results from the MEERKAT and SANDCAT studies. The agency is expected to decide on the application by July 2027.
If approved, vamikibart could become the first targeted, non-steroidal treatment for UME. Regulatory submissions have also been filed and accepted in the European Union, China and Japan.
“These one-year results strengthen vamikibart’s clinical profile, confirming that initial visual and anatomical improvements are maintained over 52 weeks,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.
Key findings from MEERKAT and SANDCAT studies
MEERKAT and SANDCAT are identical Phase III, global, multicentre, randomised, double-masked, sham comparator-controlled trials evaluating intravitreal (IVT) vamikibart in adults with UME.
Participants received 0.25 mg vamikibart, 1 mg vamikibart or sham IVT injection every four weeks for up to 16 weeks, followed by as-needed (PRN) treatment through Week 52.
At Week 52, both studies showed a numerically higher proportion of vamikibart-treated patients achieving vision gains compared with those receiving sham treatment on the primary endpoint.
Key secondary endpoints also indicated sustained improvements in best-corrected visual acuity (BCVA) and central subfield thickness (CST), a measure of retinal swelling associated with macular edema.
The findings also suggested a low treatment burden. Approximately two-thirds of eligible patients did not require retreatment after Week 16, while most of those who received additional treatment required only one more injection.
Vamikibart was well tolerated across both studies, with a favourable safety profile and a low incidence of treatment-related ocular adverse events and intraocular inflammation.
Addressing an unmet need in uveitic macular edema
Uveitic macular edema occurs when fluid accumulates in the macula, the central part of the retina responsible for detailed vision, as a result of uveitis, an inflammatory eye condition. It is a leading cause of moderate-to-severe vision loss in people with uveitis and predominantly affects working-age adults.
Corticosteroids are commonly used to treat UME, but prolonged use can increase the risk of complications, including elevated intraocular pressure, glaucoma and cataracts. Treatment options also have recognised efficacy limitations, highlighting the need for alternatives that can control inflammation while preserving vision.
“Currently, UME is commonly treated with off-label therapies or ocular steroids, the latter carrying significant long-term side effects like glaucoma and cataract formation,” said Nisha Acharya, Distinguished Professor of Ophthalmology at the University of California, San Francisco (UCSF), and Director of its Uveitis and Ocular Inflammatory Disease Service.
She added that vamikibart could offer a potential new treatment option by targeting the inflammation underlying the condition.
About Vamikibart
Vamikibart is an investigational monoclonal antibody engineered for intravitreal administration. It targets interleukin-6 (IL-6), a cytokine involved in the inflammatory pathways associated with UME.
In the Phase I DOVETAIL study, vamikibart demonstrated rapid improvements in vision and resolution of macular edema in people with UME. The treatment was also well tolerated, with no treatment-related serious adverse events reported.
Based on these findings, Roche initiated the MEERKAT and SANDCAT Phase III trials. Vamikibart is being investigated in retinal diseases involving inflammatory pathways and has received orphan drug designation in the United States and the European Union.
