NDAOPHTHALMICEMULSIONPriority Review
Approved
Dec 2002
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
RESTASIS (cyclosporine) by AbbVie is calcineurin inhibitors [moa]. Approved for dry eye disease, kidney transplantation, liver transplantation and 1 more indications. First approved in 2002.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RESTASIS (cyclosporine) is an ophthalmic emulsion formulation of the calcineurin inhibitor immunosuppressant cyclosporine, approved by the FDA on December 23, 2002. It is indicated for the treatment of dry eye disease by reducing inflammation and promoting tear production. The drug works by inhibiting calcineurin, a key enzyme in T-cell activation, thereby suppressing the immune-mediated inflammation that characterizes keratoconjunctivitis sicca. RESTASIS remains the market-leading cyclosporine product in the dry eye indication and occupies a dominant position in the ophthalmic immunosuppressant landscape.
$1.5BPart D
8.0 years to LOEMechanism of Action
Calcineurin Inhibitors
Pharmacologic Class:
Calcineurin Inhibitor Immunosuppressant
Indications (4)
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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.