Glaukos Shares Pop After Positive Data From Ocular Pressure Candidate

  • Glaukos Corporation GKOS announced positive topline data for both Phase 3 trials of iDose TR. It achieved its pre-specified primary efficacy endpoints through 3 months and demonstrated excellent tolerability and a favorable safety profile through 12 months.
  • The fast- and slow-release iDose TR arms achieved the primary efficacy endpoint of non-inferiority to the active comparator arm (topical timolol ophthalmic solution).
  • Related: Glaukos Inks Licensing Pact For Rare Eye Disorder Treatment.
  • For the GC-010 trial, the intraocular pressure (IOP) reductions from baseline were 6.6-8.5 mmHg in the slow-release iDose TR arm versus 6.6-7.7 mmHg in the timolol control arm.
  • For the GC-012 trial, IOP reductions were 6.7-8.4 mmHg in the slow-release iDose TR arm versus 6.8-7.2 mmHg in the timolol control arm.
  • 93% of slow-release iDose TR subjects remained well-controlled on the same or fewer IOP-lowering topical medications at 12 months compared to screening after a single administration of iDose TR, versus 67% of timolol control subjects.
  • Additionally, 81% of slow-release iDose TR subjects were completely free of IOP-lowering topical medications.
  • iDose TR demonstrated a favorable safety profile.
  • Glaukos plans to move forward with its plans for marketing application submission to the FDA for the slow-release iDose TR model, with an expected FDA review and decision completed by the end of 2023.
  • Price Action: GKOS shares are up 16.80% at $56.16 on the last check Wednesday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsHealth CareMoversTrading IdeasGeneralBriefswhy it's moving
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!