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Phase 3 trial of Lacripep in primary Sjögren's Syndrome

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Trial Profile

Phase 3 trial of Lacripep in primary Sjögren's Syndrome

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 21 Feb 2022

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At a glance

  • Drugs Lacritin (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Sponsors TearSolutions

Most Recent Events

  • 21 Feb 2022 New trial record
  • 14 Feb 2022 According to a TearSolutions, Inc media release, in late 2021 it received official minutes from a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the development of Lacripep for the treatment of keratoconjunctivitis sicca, also known as DED, and is planning to begin one of two phase III trials. FDA provided guidance with regard to the study design for the first phase III
  • 14 Feb 2022 According to a TearSolutions, Inc media release, The Company is currently planning the first phase III with targeted first enrollment in July 2022, for which the Company would expect top-line efficacy results from the general DED study in Q1 2023 and at the end of 2023 for the pSS DED study. The initiation and execution of the first phase III, beyond the start-up phase, is subject to additional funding or strategic partnering and may be further impacted by the COVID-19 pandemic.

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