FDA approves CEQUA to treat Dry Eye syndrome.- Sun Pharma + Sun Ophthalmics.

Sun Pharmaceutical Industries Ltd. announced that Sun Pharma has received approval for CEQUA (cyclosporine ophthalmic solution) 0.09%, from the 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 III 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.>

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.

CEQUA (cyclosporine ophthalmic solution) 0.09%, for topical ophthalmic use will be commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma�s wholly owned subsidiary. .