RESTASIS
LOE ApproachingNDAOPHTHALMICEMULSIONPriority Review
Approved
Oct 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
10
Data completeness
4/8 — Partial
Priority Review
RESTASIS by AbbVie is systemically. First approved in 2003.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RESTASIS is a cyclosporine ophthalmic emulsion approved in 2003 for keratoconjunctivitis sicca (dry eye disease). It acts as a partial immunomodulator to suppress ocular inflammation and increase tear production in patients with inflammation-associated dry eye. The exact mechanism remains incompletely understood but is thought to work systemically on tear-suppressing inflammatory pathways.
$1.5BPart D
LOE ApproachingA legacy blockbuster facing loss-of-exclusivity presents shrinking commercial opportunity; expect consolidation of brand and promotional teams.
Mechanism of Action
systemically. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, cyclosporine emulsion is thought to act as a partial immunomodulator. The exact mechanism of action is not known.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease
Started Aug 2018
100 enrolled
Dry Eye
Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis®
Started Jul 2015
51 enrolled
Dry Eye Syndromes
Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease
Started Apr 2014
55 enrolled
Dry Eye Syndromes
Study of Tisporin Eye Drops Group and Restasis Eye Drops Group After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Moderate to Severe Dry Eye Disease
Started Dec 2013
86 enrolled
Dry Eye Syndromes
Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)
Started May 2013
102 enrolled
Keratoconjunctivitis Sicca
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.