The European Medicines Agency (EMA) has approved Roche’s Vabysmo (faricimab) in single-dose prefilled syringe form for three retinal conditions that cause blindness.
Roche’s ready-to-use drug is indicated for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular oedema (DME) and macular oedema following retinal vein occlusion (RVO), as per a 13 December press release.
Shares in Roche opened 0.5% down at market open on 13 December, likely due to the separate event of Saratoga Research & Investment Management decreasing its position in the pharma company yesterday by 3.5%. The Swiss drugmaker has a market cap of $203.1bn.
Blockbuster Vabysmo has already been available in Europe for the same three diseases in 6.0mg Vabysmo vials. The drug received its most recent approval in July this year when RVO was added to its EU label.
Both the prefilled syringe and vials deliver faricimab, a bispecific antibody that blocks vascular endothelial growth factor-A (VEGF-A) and angiopoietin-2 (Ang-2). Blocking these two protein pathways stabilises blood vessels and prevents fluid leakage, the latter being the cause of vision loss in patients with the conditions.
Together, nAMD, DME and RVO affect more than nine million people in the EU, according to Roche. AMD is the leading cause of vision loss in people over 50 years of age. A 2022 report by nonprofit Retina International estimated the economic burden of late-stage AMD in Germany was €7.6bn.
Regeneron Pharmaceuticals’ Eylea (aflibercept) currently dominates the ophthalmologic market in Europe. Similar to Vabysmo, it is also available in both vials and prefilled syringes, and administered via intravitreal injection. Eylea, along with a higher-dose version at 8mg, generated global sales of $9.38bn – down 3% from 2022. Vabysmo’s sales, meanwhile, grew 324% to bring in $2.64bn.
Eylea took another hit in October when Regeneron lost an attempt to block the launch of a biosimilar developed by Pavblu. The US Food and Drug Administration (FDA) has already approved multiple aflibercept biosimilars this year.
GlobalData’s Pharma Intelligence Centre predicts a continued decrease in sales over the next five years for Eylea amid increased competition from Vabysmo and biosimilars. By 2030, Roche’s candidate is forecast to reach global sales of $8.78bn, whilst Eylea stutters to $2bn.
Roche’s chief medical officer Levi Garraway said: “Approval of the Vabysmo prefilled syringe in the EU offers a convenient way for ophthalmologists to administer this treatment for people with three of the most common causes of vision loss.”
“This simplified administration may thereby help reduce the treatment burden for patients and retina specialists.”
