Vabysmo is a bispecific antibody approved in multiple regions, including Europe, the UK, and the US, for the treatment of wAMD and DME. Credit: Pixel-Shot / Shutterstock.

Roche will present clinical and real-world data for Vabysmo (faricimab) for treating wet age-related macular degeneration (wAMD) and diabetic macular oedema (DME) at the 2023 American Society of Retina Specialists (ASRS) Annual Meeting from 28 July to 1 August in Seattle, US.

Roche’s chief medical officer Levi Garraway said in a press release: “The clinical and real-world data at ASRS reinforce the improvement in outcomes brought by Vabysmo in two leading causes of vision loss, particularly new analyses suggesting that Vabysmo is associated with less vision-impacting fibrosis than aflibercept.

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“By improving disease control while offering a potentially less frequent treatment regimen, Vabysmo may help people spend less time managing their condition.”

Vabysmo is a bispecific antibody approved in multiple regions, including Europe, the UK, and the US, for the treatment of wAMD and DME.

New data

The data from two randomised Phase III studies YOSEMITE (NCT03622580) and RHINE (NCT03622593), demonstrated less retinal fibrosis compared to Eylea (aflibercept) in patients with DME. Retinal fibrosis on the retinal surface leads to irreversible vision loss.

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Other positive anatomical changes by Vabysmo include a reduction of macular oedema, and blurry vision caused by leakage of blood vessels into a part of the retina (macula) leading to fluid build-up and swelling.

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Furthermore, data from clinical trials and multicounty real-world FARETINA studies showed that increased intervals between doses of Vabysmo did not negatively impact vision compared to Eylea.

Roche’s ophthalmic pipeline

Vabysmo is being investigated for wAMD, DME and macular oedema due to retinal vein occlusion in multiple Phase III and IV studies.

Two Phase III studies (BALATON – NCT04740905 and COMINO – NCT04740931) evaluate Vabysmo for the treatment of macular oedema following retinal vein occlusion.

 Three Phase III and expansion studies (AVONELLE-X – NCT04777201, TENAYA extension – NCT03823287, and LUCERNE – NCT03823300) assess long-term safety and efficacy of Vabysmo in patients with wAMD.

Vabysmo’s long-term safety and efficacy in DME patients are being evaluated in a Phase III extension study (NCT04432831) and a Phase IV study (NCT05224102) specifically investigating Vabysmo in treatment naïve and underrepresented patient populations.