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Phase 1/2, Safety and Efficacy Trial of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP in Patients With Retinitis Pigmentosa

Trial Profile

Phase 1/2, Safety and Efficacy Trial of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP in Patients With Retinitis Pigmentosa

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 17 Jun 2025

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At a glance

  • Drugs BS-01 (Primary)
  • Indications Retinitis pigmentosa
  • Focus Adverse reactions
  • Sponsors Bionic Sight

Most Recent Events

  • 04 Jun 2025 Planned primary completion date changed from 30 Dec 2024 to 30 Dec 2026.
  • 18 Feb 2025 According to a Bionic Sight media release, company announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational product BS01 for the treatment of retinitis pigmentosa (RP) patients with advanced stage vision loss.
  • 01 May 2023 Planned End Date changed from 30 Dec 2027 to 30 Dec 2029.

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