Sun Pharma announced that the Food and Drug Administration (FDA) has approved Cequa (cyclosporine ophthalmic solution) 0.09% for use in patients with keratoconjunctivitis sicca or dry eye disease. 

Cequa, a calcineurin inhibitor immunosuppressant, is the first cyclosporine A product to utilize nanomicellar technology. The unique formulation allows the drug molecule to overcome solubility difficulties, penetrate the eye’s aqueous layer, and prevent the release of active lipophilic molecule prior to penetration. Topical administration of cyclosporine is thought to act as a partial immunomodulator. 

Cequa was evaluated in 2 multicenter, randomized studies involving 1,048 patients with dry eye disease. Compared to vehicle at day 84, use of Cequa for 12 weeks led to a statistically significant improvement (≥10mm increase in tear production from baseline) in the Schirmer score (primary endpoint; P <.01). In both studies, the effect was seen in approximately 17% vs 9% of patients in the Cequa and vehicle groups, respectively. For secondary endpoints such as ocular staining assessments, improvements were seen as early as 1 month after starting treatment.  

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Cequa will be available as 0.9mg/mL strength preservative-free solution in 0.25mL single-use vials. Each box contains 6 pouches containing 10 vials each. The entire contents of each box should be dispensed intact. 

For more information call (800) 406-7984 or visit