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Roche's Faricimab On Par With Rival Regeneron's Aflibercept In Four Late-Stage Studies In Vision Loss Disorder

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  • Roche Holding’s (OCTMKT: RHHBY) bispecific antibody faricimab has matched Regeneron Pharmaceuticals Inc’s (NASDAQ: REGN) blockbuster drug, Eylea (aflibercept), in four Phase 3 studies, comparing the two in diabetic macular edema (DME) and wet age-related macular degeneration (AMD).
  • New data from the studies showed that faricimab, which targets VEGF and Ang2, given at intervals of up to four months, offered non-inferior vision gains compared to aflibercept, given every two months.
  • Approximately about half of the patients across all four trials eligible for extended dosing with faricimab were able to be treated every four months in the first year in the YOSEMITE and RHINE studies in DME and the TENAYA and LUCERNE studies in AMD.
  • The DME trials tested faricimab in two patient groups - those who received it every two months or those who could choose their treatment intervals of up to four months.
  • In YOSEMITE, the average vision gains from baseline were +11.6 and +10.7 eye chart letters in the faricimab personalized intervals and two-month arms, respectively, and +10.9 letters in the aflibercept arm.
  • In RHINE, the average vision gains from baseline were +10.8 and +11.8 letters in the faricimab personalized intervals and two-month arms, respectively, and +10.3 letters in the aflibercept arm.
  • The TENAYA and LUCERNE studies in AMD assessed faricimab given at fixed intervals of every two, three, or four months, selected based on their disease activity at weeks 20 and 24, compared to aflibercept given every two months.
  • Average vision gains from baseline in the faricimab arms were +5.8 and +6.6 letters, respectively, compared to +5.1 and +6.6 letters in the aflibercept arms.
  • Price Action: RHHBY increased 0.6% at $43.94, and REGN was down 0.78% at $486.94 in the market hours on the last check Friday.
 

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Posted-In: Phase 3 TrialBiotech News Health Care FDA General

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