Trial Profile

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

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 27 Oct 2015

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At a glance

Drugs Timbetasin (Primary)
Indications Dry eyes; Keratoconjunctivitis sicca
Focus Adverse reactions; Therapeutic Use
Sponsors Lee's Pharmaceutical

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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