A phase IIb study of RGN 259 eye drops for the treatment of moderate to severe dry eye in China

Trial Profile

A phase IIb study of RGN 259 eye drops for the treatment of moderate to severe dry eye in China

Planning
Phase of Trial: Phase II

Latest Information Update: 23 Oct 2015

At a glance

  • Drugs Thymosin-beta-4 (Primary)
  • Indications Dry eyes; Keratoconjunctivitis sicca
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Lees Pharmaceutical Holdings
  • Most Recent Events

    • 23 Oct 2015 According to RegeneRx Biopharmaceuticals media release, company received notice from China's FDA (CFDA) declining its IND application because the API was manufactured outside of China.
    • 17 Feb 2015 This trial is expected to be initiated before the third quarter of 2015, with results in late 2015 or early 2016, according to a RegeneRx media release.
    • 17 Feb 2015 Lees Pharmaceutical Holdings is awaiting regulatory approval to begin this dose-response study, according to a RegeneRx media release.
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