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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

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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: 12 Feb 2026

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At a glance

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

Most Recent Events

  • 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.
  • 20 Jul 2025 According to a Cloudbreak media release, Based on these positive Phase 2 results, company plans to advance CBT-004 into Phase 3 development and initiate discussions with the U.S. Food and Drug Administration (FDA) to establish the regulatory pathway toward potential approval. The company also anticipates providing updates on Phase 3 study design and timing in the coming months.

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