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A first Phase 3 Clinical trial of CLS-AX in wet AMD (Wet-age-related-macular-degeneration)

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Trial Profile

A first Phase 3 Clinical trial of CLS-AX in wet AMD (Wet-age-related-macular-degeneration)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2025

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At a glance

  • Drugs Axitinib (Primary)
  • Indications Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 30 Sep 2025 According to an Ocular Therapeutix media release, company announced the pricing of an underwritten offering and expects to use the net proceeds, together with its existing cash and cash equivalents, to fund its planned open-label extension study of AXPAXLI in patients with wet age-related macular degeneration (wet AMD), as well as its planned phase 3 clinical trials of AXPAXLI for the treatment of non-proliferative diabetic retinopathy.
  • 26 Aug 2025 According to a Clearside Biomedical media release, updates from this trial to be at the 25th EURETINA Congress from 4 - 7 Sep, 2025 in Paris, France.
  • 27 Mar 2025 According to a Clearside Biomedical media release, company announced completion of an End-of-Phase 2 meeting with the FDA and alignment on Phase 3 plans for suprachoroidal CLS-AX in wet AMD.The meeting and formal minutes confirmed key elements of the proposed pivotal Phase 3 program, including agreement on the protocol design of two non-inferiority trials, patient population, primary and secondary endpoints, and use of sham injections.

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