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A Phase 2 Multicenter, Randomized, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of CBT-004 Ophthalmic Emulsion in Patients With Vascularized Pinguecula

Trial Profile

A Phase 2 Multicenter, Randomized, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of CBT-004 Ophthalmic Emulsion in Patients With Vascularized Pinguecula

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 Apr 2026

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At a glance

  • Drugs CBT-004 (Primary)
  • Indications Pinguecula
  • Focus Adverse reactions
  • Sponsors Cloudbreak Pharma

Most Recent Events

  • 22 Apr 2026 According to Cludbreak media release, the data from the trial will be presented at Eyecelerator (partnership between ASCRS (American Society of Cataract and Refractive Surgery) and the American Academy of Ophthalmology) at the ARVO 2026.
  • 27 Jan 2026 According to a Cloudbreak media release, company announced the results of a successful End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the late-stage development of CBT-004 for the treatment of pinguecula.
  • 20 Jul 2025 Primary endpoint (Change from Baseline in conjunctival hyperemia grade at Day 28 (Week 4)) has been met.

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