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Cequa FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 17, 2018.

FDA Approved: Yes (First approved August 14, 2018)
Brand name: Cequa
Generic name: cyclosporine
Dosage form: Ophthalmic Solution
Company: Sun Pharmaceutical Industries Inc.
Treatment for: Dry Eye Disease

Cequa (cyclosporine) ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with dry eye disease (keratoconjunctivitis sicca).

Dry eye disease occurs when the quantity and/or quality of tears fails to keep the surface of the eye properly lubricated, causing a scratchy sensation or a feeling that there is something in the eye. The risk of developing dry eye increases with age, and is more common in women than in men.

Dosage and Administration

Cequa ophthalmic solution 0.9% is available in sterile, preservative-free, 0.25 mL single-use vials.

One drop is instilled into in the eye(s) twice daily (approximately 12 hours apart).

The solution from each individual single-use vial is to be used immediately after opening, and the remaining contents should be discarded immediately after administration.

Warnings and Precautions

Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, patients are advised not to touch the vial tip to the eye or other surfaces.

Use with Contact Lenses: Cequa should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of Cequa ophthalmic solution.

Adverse Reactions

The most common adverse reactions (reported in >5% of patients were pain on instillation of drops and conjunctival hyperemia (redness). Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection.

Development timeline for Cequa

Aug 16, 2018Approval Sun Pharma Announces FDA Approval of Cequa (cyclosporine) Ophthalmic Solution to Treat Dry Eye Disease

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.