Sun Pharmaceutical Industries Ltd. has received approval for CEQUA (cyclosporine ophthalmic solution 0.09%), from the U.S. Food and Drug Administration (FDA). CEQUA is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).
CEQUA incorporates a nanomicellar technology that allows the cyclosporine A (CsA) molecule to overcome solubility challenges, penetrate the eye’s aqueous layer and prevent the release of the active lipophilic molecule prior to penetration. The nanomicellar formulation technology uses micelles, which are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules formed at a well-defined concentration. The small size of the nanomicelles facilitates entry into corneal and conjunctival cells, enabling delivery of high concentrations of CsA.
In the Phase 3 confirmatory trial on CEQUA, after 12 weeks of treatment, CEQUA showed statistically significant improvement in the primary endpoint of Schirmer’s score (a measurement of tear production). Improvements in secondary endpoints, namely staining assessments) were seen as early as one month after initiating treatment.
CEQUA is dosed twice daily and will be available as a single-use vial. CEQUA will be commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary. Go to SunPharma.com.