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A Phase 2/3 Double-Masked, Randomized, 2 Stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema

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Trial Profile

A Phase 2/3 Double-Masked, Randomized, 2 Stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema

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

Latest Information Update: 28 Apr 2026

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At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Diabetic macular oedema
  • Focus Registrational; Therapeutic Use
  • Acronyms DIAMOND; DIAMOND 1
  • Sponsors Oculis Pharma

Most Recent Events

  • 20 Apr 2026 According to an Oculis Pharma media release,company announced completion of the final patient visit in the OCS-01 Phase 3 DIAMOND program in diabetic macular edema (DME) and expects to report topline results in June 2026 followed by a potential NDA submission in Q4 2026.
  • 31 Mar 2026 This trial has been discontinued due to sponsor decision in Spain and Hungary.
  • 09 Jan 2026 According to an Oculis Pharma media release, Topline results from both DIAMOND Phase 3 trials are expected in Q2 2026 with NDA submission to the FDA planned for Q4 2026.

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