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Phase 3 pivotal clinical study of OTX-TKI for the treatment of Diabetic Retinopathy

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Trial Profile

Phase 3 pivotal clinical study of OTX-TKI for the treatment of Diabetic Retinopathy

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 21 Jan 2025

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At a glance

  • Drugs Axitinib (Primary)
  • Indications Diabetic retinopathy
  • Focus Adverse reactions; Registrational

Most Recent Events

  • 14 Jan 2025 According to an Ocular Therapeutix media release, company plans to seek FDA feedback in H1 2025 on clinical trial design for AXPAXLI in NPDR
  • 06 Apr 2024 According to an Ocular media release, positive HELIOS results support decision to move directly to a Phase 3 study with AXPAXLI in patients with NPDR, pending discussions with the FDA.
  • 18 Dec 2023 According to an Ocular Therapeutix media release, company announced Closing of Public Offering of Common Stock and Full Exercise by Underwriters of Option to Purchase Additional Shares and to use the net proceeds from this offering, together with its existing cash and cash equivalents, to fund this trial.

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