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A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of OCS-01 Ophthalmic Suspension in the Treatment of Inflammation and Pain Following Cataract Surgery

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Trial Profile

A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of OCS-01 Ophthalmic Suspension in the Treatment of Inflammation and Pain Following Cataract Surgery

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2024

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At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Postoperative inflammation; Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Acronyms OPTIMIZE-2
  • Sponsors Oculis Pharma

Most Recent Events

  • 10 Dec 2024 Status changed from recruiting to discontinued. (Sponsor decision to close study due to third-party administrative error preventing analysis of trial results. There was no issue in terms of quality of the investigational product, and no safety risk to any study subject.)
  • 27 Aug 2024 According to Oculis Pharma media release, The Company will close the Phase 3 OPTIMIZE-2 trial due to a third-party administrative error which affected the conduct of the trial and prevents analysis of trial results.
  • 18 Mar 2024 According to an Oculis media release, R & D expenses were CHF 8.0 million or $9.0 million for the three-months ended Dec 31, 2023, compared to CHF 6.9 million or $7.1 million in the same period in 2022. The increase was primarily due to the commencement of three clinical trials during the fourth quarter of 2023: DIAMOND-1 Stage 2, OPTIMIZE-2 and RELIEF.

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