Author’s Name(s): Nupura Bakshi, Carlos Pavesio, Eric Suhler, Phoebe Lin, Meike Pauly- Evers, Daniela Willen, William Holmes, Federica Storti, Zeinab Barekati, Tatiana Gott, Benedicte Passemard, Lachlan Macgregor, Sumit Sharma, Sascha Fauser, Marina Mesquida

Author’s Disclosure Block: Nupura Bakshi: Roche, Grant/research support, Bayer, Membership on an advisory panel, standing committee or board of directors, Biogen, Membership on an advisory panel, standing committee or board of directors; Carlos Pavesio: AbbVie, Alimera, Allergan, Roche; Eric Suhler: Consultant: AbbVie, Clearside Biomedical, EyePoint, Gilead Sciences, Kriya, Roche; Research Support: AbbVie, Clearside Biomedical, EyePoint, Gilead Sciences, Roche; Phoebe Lin: Consultant: Bausch + Lomb, Roche/Genentech, Inc; Meike Pauly- Evers: F. Hoffmann-La Roche Ltd.; Stock/Stock Options: Roche; Daniela Willen: Employee: F. Hoffmann-La Roche Ltd.; Stock/Stock Options: Roche; William Holmes: Employee: Roche Products Ltd.; Stock/Stock Options: Roche; Federica Storti: Employee: F. Hoffmann-La Roche Ltd.; Stock/Stock Options: Roche; Zeinab Barekati: F. Hoffmann-La Roche Ltd.; Stock/Stock Options: Roche; Tatiana Gott: Employee: Roche Translational & Clinical Research Center; Stock/Stock Options: Roche; Benedicte Passemard: Employee: F. Hoffmann-La Roche Ltd.; Stock/Stock Options: Roche; Lachlan Macgregor: Employee: F. Hoffmann-La Roche Ltd., Stock/Stock Options: Roche; Sumit Sharma: Consultant: AbbVie, Alimera, Bausch + Lomb, Clearside Biomedical, EyePoint, Genentech, Inc., Regeneron, Regenxbio, Roche; Research Support: EyePoint, Genentech, Inc., Gilead Sciences, Ionis, Roche, Santen; Sascha Fauser: Employee: F. Hoffmann-La Roche Ltd., Stock/Stock Options: Roche; Marina Mesquida: Employee: F. Hoffmann-La Roche Ltd., Stock/Stock Options: Roche; Lachlan Macgregor: Employee: F. Hoffmann-La Roche Ltd.; Stock/Stock Options: Roche; Sumit Sharma MD: Consultant: AbbVie, Alimera, Bausch + Lomb, Clearside Biomedical,EyePoint, Genentech, Inc., Regeneron, Regenxbio, Roche; Research Support: EyePoint, Genentech, Inc., Gilead Sciences, Ionis, Roche, Santen; Sascha Fauser: Financial Disclosures: Employee: F. Hoffmann-La Roche Ltd.; Stock/Stock Options: Roche; Marina Mesquida, Financial Disclosures: Employee: F. Hoffmann-La Roche Ltd.
 

Abstract Body
Purpose:Inflammation is a key pathway in retinal disease pathophysiology. However, anti-inflammatory corticosteroid use carries a significant risk of side effects. Vamikibart (RG6179) is a recombinant monoclonal antibody that potently inhibits all forms of interleukin-6 signalling. We report the final results of intravitreal (IVT) vamikibart treatment in patients with uveitic macular edema (UME) from the DOVETAIL study. Study Design: DOVETAIL is a phase 1, multicenter, nonrandomized, open-label, multiple ascending dose study to investigate the safety, tolerability, efficacy, and pharmacokinetics/pharmacodynamics profile of vamikibart in both diabetic macular edema (DME) and UME.
Methods: Patients ≥ 18 years of age with noninfectious uveitis and concurrent macula edema (central subfield thickness ≥ 325 μm) were included (N = 37). Patients were enrolled into 3 dose groups – 0.25 mg (n = 12), 1 mg (n = 12), and 2.5 mg (n = 13) – and received IVT vamikibart at weeks 0, 4, and 8, followed by post-treatment observation until week 36. Results: The DOVETAIL study has recently concluded, and the baseline characteristics, final exploratory efficacy outcomes, and safety data for patients with UME will be available for presentation. Promising preliminary efficacy and safety results for patients with UME from the DOVETAIL study have been reported previously (Sharma A et al. J Vitreoretin Dis. 2023;7(6):474-476). Conclusions: This phase 1 clinical trial will provide data on the safety and efficacy of vamikibart IVT therapy in patients with UME. Two phase 2 studies in DME (monotherapy [NCT05151731] and in combination with ranibizumab [NCT05151744]) and 2 phase 3 trials in UME (MEERKAT [NCT05642312] and SANDCAT [NCT05642325]) are currently underway to further assess the clinical potential of vamikibart in retinal diseases.