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A Phase 3, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration

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Trial Profile

A Phase 3, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 May 2025

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At a glance

  • Drugs Axitinib (Primary) ; Aflibercept
  • Indications Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms SOL-R
  • Sponsors Ocular Therapeutix

Most Recent Events

  • 28 May 2025 According to an Ocular Therapeutix media release, The FDA has agreed that together, SOL-1 and SOL-R could constitute two adequate and well-controlled trials to support a potential New Drug Application (NDA) and label for AXPAXLI in wet AMD. Pending positive results from SOL-1 and SOL-R, Ocular plans to submit an NDA for FDA review following 56-week data from SOL-R.
  • 28 May 2025 According to an Ocular Therapeutix media release, company announced that enrollment in the SOL-R registrational trial of its product candidate AXPAXLI in wet age-related macular degeneration (wet AMD) will close this week.
  • 03 Mar 2025 According to an Ocular Therapeutix media release, trial protocol modified to randomize approximately 555 subjects (previously 825) as enrollment continues to stay strong.

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