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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 (nAMD)

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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 (nAMD)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2025

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At a glance

  • Drugs Axitinib (Primary) ; Aflibercept
  • Indications Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms SOL-1
  • Sponsors Ocular Therapeutix

Most Recent Events

  • 04 Nov 2025 According to an Ocular Therapeutix media release, topline data from this trial is expected in Q1 2026.
  • 04 Nov 2025 According to an Ocular Therapeutix media release, Pending positive results from SOL-1 and SOL-R, Ocular plans to submit a New Drug Application (NDA) for FDA review following 56-week topline data from SOL-R.
  • 05 Aug 2025 According to an Ocular Therapeutix media release,The Company plans to incorporate a single long term, open label extension study for both SOL trials (SOL 1 and SOL R), Subjects will be eligible to enter the extension study be eligible to enter this study after completing the two year safety follow up period in either of SOL trials.

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