The European Commission (EC) has approved Roche’s Vabysmo (faricimab) for the treatment of retinal vein occlusion, adding a third indication for the company’s blockbuster drug.
The approval is specifically for the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO), according to a 30 July press release. RVO is the second most common cause of vision loss due to retinal vascular diseases, after macular degeneration.
The regulatory greenlight in Europe follows approval in the US; Vabysmo was approved for RVO by the US Food and Drug Administration in October 2023.
Along with RVO, Vabysmo is approved for wet age-related macular degeneration (AMD) and diabetic macular oedema (DME) in Europe. The three conditions are among the leading causes of vision loss, affecting around 80 million people worldwide, according to Roche.
Vabysmo is the first bispecific antibody approved for the eye. It works by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), proteins that contribute to vision loss by destabilising blood vessels and creating new leaky vessels.
GlobalData senior pharma analyst Sara Reci said: “If Roche’s Vabysmo continues to provide promising sales figures for the foreseeable future, in addition to the company’s anticipated re-launch of Susvimo and Suvsimo’s label expansion, Roche will have put itself on track to becoming an industry leader within the ophthalmological space.”
Susvimo is another product from Roche’s pipeline indicated for wet AMD.
Earlier this month, a prefilled syringe version of Vabysmo was approved in the US for the same three vision loss conditions. The ready-to-use dosing option will be available to US retina specialists and patients later this year.
The RVO approval was based on positive results from two Phase III studies. The BALATON (NCT04740905) and COMINO (NCT04740931) studies compared Vabysmo to Regeneron’s Eylea (aflibercept) in 1,282 patients with different forms of RVO. Both studies met their primary endpoint of non-inferior visual acuity gains at 24 weeks. Longer-term data showed that 60% of patients in BALATON and 48% in COMINO were able to extend their treatment intervals to three to four months apart. Currently, RVO treatments are administered every couple of months.
Roche’s chief medical officer Levi Garraway said: “Vabysmo is a new treatment option for people with retinal vein occlusion in Europe that can help preserve and improve vision, with the added benefit of retinal drying.”
Regeneron’s Eylea currently dominates the ophthalmology market, netting $5.89bn in sales last year. However, product revenues were down by 6.3% from the year before due to increased competition from Vabysmo and others. Regeneron has also been locked in various court battles over alleged patent infringements from the company’s deploying aflibercept biosimilars.
Vabysmo surged through the blockbuster qualifying line in only its second year on the market, notching $2.66bn in global sales in 2023. The drug is predicted to see revenues of $8.5bn by 2030, according to GlobalData’s Pharma Intelligence Centre.
GlobalData is the parent company of Pharmaceutical Technology.
