Novel anti-IL-6 antibody shows promise in uveitic macular edema

Interleukin (IL)-6 inhibition with vamikibart is safe and well tolerated and helps improve clinical outcomes in patients with uveitic macular edema (UME), as shown in the phase I DOVETAIL nonrandomized clinical trial.

DOVETAIL included 37 adult patients (mean age 63.5 years, 59.5 percent female, 91.9 percent White) with UME secondary to noninfectious uveitis, with optical coherence tomography central subfield thickness (CST) of ≥325 µm and a best-corrected visual acuity (BCVA) letter score of 78 to 19.

The patients were assigned to receive intravitreal injections of vamikibart at 0.25 mg (n=12), 1 mg (n=12), or 2.5 mg (n=13). Treatment was administered at day 1, week 4, and week 8. All patients were followed up until week 20 (2.5-mg group) or 36 (0.25- and 1-mg groups).

Safety and tolerability were assessed as the primary outcomes. BCVA and CST were also evaluated in exploratory analysis.

At week 12, BCVA letter score increased by a mean of 9.9 from baseline overall, corresponding to an approximate 2-line improvement (11.1 in the 0.25-mg group, 10.3 in the 1-mg group, and 8.4 in the 2.5-mg group). CST decreased by a mean of 165.1 µm (−125.0, −188.1, and −183.6 µm in the respective dose groups).

Thirty-six patients completed the 12-week vamikibart treatment. Among these patients, ocular adverse events (AEs) in the study eye occurred in 51.4 percent, including one case of serious uveitis worsening unrelated to the study drug and one case of treatment-related transient decrease in visual acuity. None of the patients had retinal vasculitis (occlusive or nonocclusive).