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Opthea Outlines OPT-302 Pivotal Study Designs In Chronic Eye Disorder

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  • Following consultations with FDA and European Medical Agency, Opthea NASDAQ: OPT) has finalized trial designs for two Phase 3 clinical trials to assess 2 mg OPT-302, administered 4-weekly or 8-weekly in wet age-related macular degeneration (AMD).
  • Each trial will enroll around 990 treatment-naive patients and assess the efficacy and safety of intravitreal 2.0 mg OPT-302 in combination with 0.5 mg Roche's Lucentis (ranibizumab) (ShORe trial) or 2.0 mg Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) Eylea (aflibercept) (COAST trial), compared to ranibizumab or aflibercept monotherapy, respectively.
  • The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity from baseline to week 52 for OPT-302 combination therapy compared to monotherapy.
  • Each patient will continue to be treated for a further year to evaluate extended safety and tolerability over two years.
  • The trials will start in the first quarter of 2021, with topline data expected in the second half of 2023.
  • Price Action: OPT closed 3.5% lower at $10.93 on Tuesday.
 

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Posted-In: Age-Related Macular DegenerationBiotech News Health Care FDA General

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