A Phase 2, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of Three Different Concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution in Subjects With Dry Eye Using the Controlled Adverse Environment (CAE) Model
Phase of Trial: Phase II
Latest Information Update: 15 Aug 2017
At a glance
- Drugs Lifitegrast (Primary)
- Indications Dry eyes
- Focus Registrational; Therapeutic Use
- Sponsors Shire
- 15 Aug 2017 According to a Shire media release, based on the data from this and other four trials (see profiles 251148, 239561, 239552 and 239399), the Marketing Authorization Application (MAA) for lifitegrast, submitted on 07 August 2017, has been validated by the UK as the Reference Member State involved in the Decentralized Procedure (DCP) MAA was submitted to Denmark, Norway, Sweden, Finland, the UK, Germany, the Netherlands, France, Italy, Portugal, Spain and Greece.
- 14 Feb 2017 According to a Shire Pharma media release, company has filed a New Drug Submission (NDS) with Health Canada for the marketing authorization of lifitegrast for the treatment of dry eye disease in adults in Canada.
- 04 Feb 2016 According to a Shire media release, the US FDA has acknowledged the receipt of resubmission of NDA for lifitegrast.