CHMP recommends EU approval of Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss

  • Vabysmo (faricimab) simultaneously targets and inhibits two disease pathways that drive neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME)
  • The CHMP recommendation is based on results across four phase III studies: TENAYA and LUCERNE in nAMD at year one, and YOSEMITE and RHINE in DME up to two years
  • The totality of the data across all studies in nAMD and DME available to date showed that over 60% of people treated with Vabysmo were able to extend treatment to every four months, while improving and maintaining vision
  • If approved, Vabysmo would offer the first new mechanism of action in over a decade for people in the EU with nAMD and DME

Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Vabysmo®️ (faricimab) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). Based on this recommendation, a final decision regarding the approval of Vabysmo is expected from the European Commission in the near future.

Neovascular AMD and DME are two leading causes of vision loss, together affecting over 40 million people worldwide. 1,2,3,4 The current standards of care typically require eye injections every one to two months. 5,6 Vabysmo has the potential to extend the time between eye injections to up to four months while improving and maintaining vision. 7,8,9,10 If approved, it would offer the first new mechanism of action in over a decade for people in the EU with these conditions. 11,12

“Today’s recommendation marks a significant step forward in redefining treatment for people in the EU with nAMD and DME,” said Levi Garraway, M.D., PhD., Roche’s Chief Medical Officer and Head of Global Product Development. “With the potential to require fewer injections over time while also improving and maintaining vision, Vabysmo could offer a less burdensome treatment schedule for patients, their caregivers, and healthcare systems.”

The CHMP recommendation is based on results across four phase III studies: TENAYA and LUCERNE in nAMD at year one, and YOSEMITE and RHINE in DME up to two years. The studies showed that people treated with Vabysmo at intervals of up to four months achieved non-inferior vision gains versus aflibercept given every two months. 7,8,9 The totality of the data across all four studies in nAMD and DME available to date showed that over 60% of people treated with Vabysmo were able to extend treatment to every four months, while improving and maintaining vision. 7,8,9,10 Vabysmo was generally well tolerated in all four studies, with a favourable benefit-risk profile. 7,8,9

Vabysmo is the first bispecific antibody for the eye. It targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). By independently blocking both pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels and thereby reduce inflammation, leakage and abnormal vessel growth (neovascularisation) more than inhibition of VEGF-A alone. 7 This sustained blood vessel stabilisation may improve disease control and vision outcomes for longer. 7,8

Roche has a robust phase III clinical development programme for Vabysmo. The programme includes AVONELLE-X, an extension study of TENAYA and LUCERNE evaluating the long-term safety and tolerability of Vabysmo in nAMD, and RHONE-X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and tolerability of Vabysmo in DME. 13,14 Additionally, the COMINO and BALATON trials are also underway, evaluating the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion. 15,16 Roche has also initiated the phase IV Elevatum study of Vabysmo in underrepresented patient populations with DME. 17

Vabysmo was generally well tolerated in both studies, with a favourable benefit-risk profile. In TENAYA and LUCERNE, the most common adverse reactions (≥3% of participants) included cataract, conjunctival haemorrhage, vitreous floaters, retinal pigment epithelial tears, increase of intraocular pressure and eye pain. Safety results were consistent across study arms.

Vabysmo was generally well tolerated in both studies, with a favourable benefit-risk profile. In YOSEMITE and RHINE, the most common adverse reactions (≥3% of participants) included cataract, conjunctival haemorrhage, vitreous floaters, increase of intraocular pressure and eye pain. Safety results were consistent across study arms.

About diabetic macular edema
Affecting around 21 million people globally, diabetic macular edema (DME) is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated. 3,25 DME occurs when damaged blood vessels leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving. 21,26 The number of people with DME is expected to grow as the prevalence of diabetes increases. 27

About Vabysmo®️ (faricimab) 8
Vabysmo is the first bispecific antibody approved for the eye. It targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

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