Vabysmo®

VABYSMO® (faricimab), vial containing 28.8 mg faricimab (single dose corresponding to 6 mg faricimab/0.05 ml injection solution) for intravitreal use.

Swissmedic authorisation number: 68395
Swissmedic authorisation date: 25 May 2022
 

Pivotal studies (4):

1. TENAYA (NCT03823287, GR40306)

Indication: Neovascular (wet) age-related macular degeneration (nAMD)

Phase: III

Summary: Randomised, double-masked, multicentre, active comparator-controlled study to evaluate the efficacy and safety of intravitreal treatment with Vabysmo compared to intravitreal treatment with aflibercept (Eylea) in patients with nAMD.

Sponsor: F. Hoffmann-La Roche Ltd

2. LUCERNE (NCT03823300, GR40844)

Indication: Neovascular (wet) age-related macular degeneration (nAMD)

Phase: III

Summary: Randomised, double-masked, multicentre, active comparator-controlled study to evaluate the efficacy and safety of intravitreal treatment with Vabysmo compared to intravitreal treatment with aflibercept (Eylea) in patients with nAMD.

Sponsor: F. Hoffmann-La Roche Ltd

3. RHINE (NCT03622593, GR40398)

Indication: Diabetic macular oedema (DMO)

Phase: III

Summary: Randomised, double-masked, multicentre, active comparator-controlled study to evaluate the efficacy and safety of intravitreal treatment with Vabysmo compared to intravitreal treatment with aflibercept (Eylea) in patients with DMO.

Sponsor: F. Hoffmann-La Roche Ltd

4. YOSEMITE (NCT03622580, GR40349)

Indication: Diabetic macular oedema (DMO)

Phase: III

Summary: Randomised, double-masked, multicentre, active comparator-controlled study to evaluate the efficacy and safety of intravitreal treatment with Vabysmo compared to intravitreal treatment with aflibercept (Eylea) in patients with DMO.

Sponsor: F. Hoffmann-La Roche Ltd


Disclaimer: Publication of clinical trial results
The above information and the links provided to clinical data meet the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO) and supplement the information published in connection with the Swiss authorisation of Vabysmo. Articles 71-73 TPO apply to all medicinal products submitted and authorised by Swissmedic from January 2019 onwards. The published data will help doctors and other healthcare providers to make informed treatment decisions and enable researchers to build more easily on the research conducted by Roche and its partners, as well as by other researchers, in order to drive scientific progress.