Roche Presents New Phase III Pivotal Data for Vamikibart in Uveitic Macular Edema

Strategic Insights -

Roche, a global pharmaceutical company, has presented new phase III pivotal data for vamikibart, a non-steroid targeted therapy designed to address inflammation driving uveitic macular edema (UME). The data, presented at the American Academy of Ophthalmology annual meeting (AAO 2025), demonstrate the potential of vamikibart in providing a new treatment option for patients with UME.

The pivotal studies, MEERKAT and SANDCAT, evaluated the efficacy and safety of two doses of vamikibart (0.25 and 1 mg) compared with a sham procedure that mimics intravitreal (IVT) injections in people with UME. The primary and secondary endpoint data support the potential for rapid improvements in vision and reductions in macular thickness with vamikibart treatment.

Key Takeaways:

  • Vamikibart is the first non-steroid targeted therapy designed to address inflammation driving UME and may offer a potential new treatment option for patients.
  • Vision improvements were seen in both pivotal studies, achieving statistical significance in MEERKAT and nominal significance in SANDCAT.
  • The MEERKAT and SANDCAT trials are ongoing, and the data will be discussed with health authorities globally.
  • Vamikibart was generally well tolerated in both studies, with a low incidence of treatment-related ocular adverse events (AEs) and intraocular inflammation (IOI) events.
  • The most common AEs (≥5%) in either trial in patients receiving vamikibart were conjunctival hemorrhage and raised intraocular pressure.
  • The underlying variability of best corrected visual acuity (BCVA) as an endpoint, along with variations in patient baseline characteristics and concomitant medications, may have influenced the differences in trial primary outcomes.
  • Further analyses are currently underway to address these differences and confirm the efficacy and safety of vamikibart.

Statistics:

  • The primary endpoint data demonstrated statistically significant superiority over sham in MEERKAT (19.9% improvement, P=0.0008) and nominal significance in SANDCAT (36.9% improvement, P=0.01).
  • A numerically higher proportion of patients treated with vamikibart gained vision in both trials (MEERKAT: 36.5% and SANDCAT: 43.0%).
  • The average change from baseline in best corrected visual acuity (BCVA) was significantly improved with vamikibart treatment in both trials (MEERKAT: +15.6 letters and SANDCAT: +19.4 letters).
  • The average change from baseline in central subfield thickness (CST) was also significantly improved with vamikibart treatment in both trials (MEERKAT: -154.6 μm and SANDCAT: -172.1 μm).

Sources:

  • M2 PressWIRE, October 20, 2025: "Roche presents new phase III pivotal data for vamikibart in uveitic macular edema (UME)"
  • American Academy of Ophthalmology (AAO) 2025 annual meeting, Orlando, Florida, United States (2025)