Key Takeaways

• Phase 1 data for vamikibart (RG6179/EBI-031, Genentech/Roche) show that this therapy for uveitic macular edema is safe and tolerable.
• At 12 weeks, the mean (standard deviation [SD]) change from baseline in BCVA was +9.9 (8.9) letters, an approximate 2-line improvement, and mean (SD) CST reduction was −165.1 (147.5) µm.
• The MEERKAT and SANDCAT phase 3 trials are underway to further evaluate vamikibart in uveitic macular edema.

Researchers recently published in JAMA Ophthalmology their findings of the phase 1 DOVETAIL nonrandomized clinical trial investigating vamikibart (RG6179/EBI-031, Genentech/Roche), an anti-interleukin-6 (IL-6) monoclonal antibody, for the treatment of uveitic macular edema (UME).

The study assessed the safety, tolerability, and effects of intravitreal vamikibart in 37 patients with UME secondary to noninfectious uveitis (NIU). Participants were enrolled into three dose groups (0.25 mg, 1 mg, or 2.5 mg) and received treatment at day 1, week 4, and week 8, followed by observation until weeks 20 (2.5 mg) or 36 (0.25 mg or 1 mg).

At 12 weeks, vamikibart (all doses) was tolerated and associated with improved BCVA and central subfield thickness (CST). The mean (standard deviation [SD]) change from baseline in BCVA was +9.9 (8.9) letters, an approximate 2-line improvement, and mean (SD) CST reduction was −165.1 (147.5) µm. Of the 37 participants, 36 continued vamikibart throughout the 12 weeks. Ocular adverse events (AEs) in the study eye were reported in 19 patients (51.4%), including one serious AE (uveitis worsening, unrelated to study drug) and one treatment-related AE (transient VA reduction). No cases of retinal vasculitis were reported.

The study authors concluded that these results support the safety, tolerability, and potential effects of vamikibart for UME secondary to NIU. The phase 3 MEERKAT (NCT05642312) and SANDCAT (NCT05642325) trials are underway to further evaluate vamikibart in UME.