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# Sun Pharma Tear Production Drug Approved
- URL: https://www.fdaweb.com/sun-pharma-tear-production-drug-approved/
- Published: 2018-08-16T12:00:00.000Z
- Updated: 2026-09-15T00:26:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142136

FDA has approved Sun Pharmaceutical Industries’ Cequa (cyclosporine ophthalmic solution) 0.09%, indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). The drops provide the highest FDA-approved concentration of cyclosporine A and is the first cyclosporine A product that incorporates a nanomicellar technology, according to the company. The formulation “allows the CsA molecule to overcome solubility challenges, penetrate the eye’s aqueous layer and prevents the release of the active lipophilic molecule prior to penetration,” it says.

Approval is based on data from a Phase 3 confirmatory trial of Cequa compared to a vehicle, where the active drug showed statistically significant improvement in tear production, Sun says. Improvements in secondary endpoints (i.e. ocular staining assessments) were seen as early as one month after starting treatment. Cequa is dosed twice daily and will be available as a single-use vial.