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