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Efficacy and Safety of Vamikibart Patients With Uveitic Macular Edema: Week 16 Results from the Phase 3 MEERKAT and SANDCAT Trials
Presenter:
Quan Dong Nguyen, MD, MSc
Authors:
1. Quan Dong Nguyen, MD, MSc (presenting author). 2. Rahul N. Khurana, MD. 3. Nisha Acharya, MD, MS. 4. Carlos Pavesio, MD, FRCOphth. 5. Koh-Hei Sonoda, MD, PhD. 6. Deanna Galloway, MSc. 7. Zdenka Haskova, MD, PhD. 8. Emma Harrell, BSc (Hons). 9. Marina Mesquida, MD, MSc, PhD. 10. David Silverman, MSc, MBChB, MRCOphth. 11. André Vicente, MD, PhD. 12. Laura Steeples, MBChB (Hons), FRCOphth. 13. Eric Suhler, MD, MPH.
1. Byers Eye Institute, Stanford University, Palo Alto, CA
2. Northern California Retina Vitreous Associates, Mountain View, CA; Department of Ophthalmology, University of California San Francisco, San Francisco, CA
3. Francis I. Proctor Foundation and Department of Ophthalmology, University of California San Francisco, San Francisco, CA
4. Moorfields Eye Hospital, London, UK
5. Department of Clinical Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan
6. Roche Products Ltd., Welwyn Garden City, UK
7. Genentech, Inc., South San Francisco, CA
8. Roche Products Ltd., Welwyn Garden City, UK
9. F. Hoffmann-La Roche Ltd., Basel, Switzerland
10. Roche Products Ltd., Welwyn, UK
11. F. Hoffmann-La Roche Ltd., Basel, Switzerland
12. Roche Products Ltd., Welwyn, UK
13. Casey Eye Institute, Oregon Health & Science University, Portland, OR
Affiliation:
Purpose
Interleukin-6 (IL-6) is a key inflammatory mediator in the pathogenesis of uveitic macular edema (UME), a vision-threatening complication of noninfectious uveitis (NIU). Vamikibart is a first-in-class anti–IL-6 recombinant, humanized, monoclonal antibody designed for intravitreal (IVT) administration. Here, we present Week (W)16 results from the phase 3 MEERKAT and SANDCAT trials.
Methods
MEERKAT (MK; NCT05642312; N=245) and SANDCAT (SC; NCT05642325; N=256) are identical global phase 3 trials evaluating the efficacy and safety of IVT vamikibart (0.25 mg, 1.0 mg, vs sham; 1:1:1; 4× monthly then pro re nata to W48) in adult patients with UME (central subfield thickness [CST] ≥325 µm and best-corrected visual acuity [BCVA] score of 73–19 letters). All NIU etiologies and anatomical types were included, as well as both active and inactive NIU at baseline. The primary endpoint was the proportion of patients with a ≥15-letter gain in BCVA from baseline at W16; secondary endpoints included change from baseline (CFB) in BCVA and CST at W16.
Results
Vamikibart showed clinically meaningful efficacy vs sham at W16. Proportion of patients with ≥15-letter improvement in BCVA for MK/SC: 26.1/34.0% 0.25 mg, 43.2/24.2% 1.0 mg vamikibart vs 6.3/13.3% sham. Mean CFB in BCVA for MK/SC: +9.6/+11.9 letters 0.25 mg, +12.8/+9.2 letters 1.0 mg vamikibart vs +3.5/+5.0 letters sham. Mean CFB in CST for MK/SC: –187.5/–209.7 µm 0.25 mg, –196.1/–194.7 µm 1.0 mg vamikibart vs –58.5/–43.5 µm sham. Overall, the incidence of serious ocular adverse events, intraocular inflammation, and elevated intraocular pressure was low, and there were no events of retinal occlusive vasculitis.
Conclusions
Vamikibart, a novel IVT anti–IL-6 therapy, demonstrated efficacy in vision and anatomical outcomes, and was well tolerated in patients with UME. Vamikibart is a non-steroid treatment that directly targets macular edema due to ocular inflammation.