Posted by Michael Wonder on 17 Aug 2018
Sun Pharma announces U.S. FDA approval of Cequa to treat dry eye disease
16 August 2018 - Cequa (cyclosporine ophthalmic solution) 0.09% for topical ophthalmic use is the first and only dry eye treatment to combine cyclosporine A with nanomicellar technology.
Sun Pharmaceutical Industries today announced that Sun Pharma has received approval for Cequa (cyclosporine ophthalmic solution) 0.09%, from the U.S. FDA. Cequa is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).
Cequa provides the highest FDA-approved concentration of cyclosporine A (CsA) and is the first and only approved CsA product that incorporates a nanomicellar technology. The innovative nanomicellar 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. In the Phase 3 confirmatory trial on Cequa, after 12 weeks of treatment, as compared to vehicle, Cequa showed statistically significant improvement in the primary endpoint, Schirmer’s score (a measurement of tear production) (p<0.01). Improvements in secondary endpoints (i.e. ocular staining assessments) were seen as early as 1 month after initiating treatment. Cequa is dosed twice daily and will be available as a single-use vial.
