Swissmedic authorisation number: 68395
Swissmedic authorisation date: 25 May 2022
1.
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 faricimab compared to intravitreal treatment with aflibercept in patients with nAMD.
Sponsor: F. Hoffmann-La Roche Ltd
2.
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 faricimab compared to intravitreal treatment with aflibercept in patients with nAMD.
Sponsor: F. Hoffmann-La Roche Ltd
3.
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 faricimab compared to intravitreal treatment with aflibercept in patients with DMO.
Sponsor: F. Hoffmann-La Roche Ltd
4.
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 faricimab compared to intravitreal treatment with aflibercept in patients with DMO.
Sponsor: F. Hoffmann-La Roche Ltd
5.
Indication: Branch retinal vein occlusion
Phase: III
Summary: Randomized, double-masked, multicenter, active comparator-controlled, parallel-group study evaluating the efficacy and safety of faricimab administered by intravitreal (IVT) injection, compared to IVT treatment with aflibercept until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).
Sponsor: F. Hoffmann-La Roche Ltd
6.
Indication: Central retinal vein occlusion
Phase: III
Summary: Randomized, double-masked, multicenter, active comparator-controlled, parallel-group study evaluating the efficacy and safety of faricimab administered by intravitreal (IVT) injection, compared to IVT treatment with aflibercept until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).
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.
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