Trial Profile
A Phase 3, Multicenter, Randomized, Double-masked, and Placebo-controlled Study Evaluating the Efficacy and Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease and History of Recent Artificial Tear Use
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 04 May 2022
Price :
$35
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At a glance
- Drugs Lifitegrast (Primary)
- Indications Dry eyes
- Focus Registrational; Therapeutic Use
- Acronyms OPUS-3
- Sponsors Shire
- 29 Jun 2020 According to a Takeda media release, Novartis Europharm Limiteds (Novartis) has withdrawn the Marketing Authorisation Application (MAA) for Xiidra (lifitegrast ophthalmic solution) 5% product (Xiidra) in Europe, as posted on the European Medicines Agencys website on 26th Jun 2020.
- 03 Jan 2018 According to a Shire plc media release, Xiidra (lifitegrast ophthalmic solution 5%) has been approved in Canada for the treatment of dry eye disease based on results from five trials including this one.
- 15 Aug 2017 According to a Shire media release, based on the data from this and other four trials (see profiles 245946, 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.