Medication Monitor

Generic Name (Trade Name—Company)
August 20, 2018

Cyclosporine ophthalmic solution 0.09%

(Cequa—Sun Pharma)
New solution treats dry eye disease

Sun Pharma announced FDA approval of cyclosporine ophthalmic solution 0.09% to increase tear production in patients with keratoconjunctivitis sicca (dry eye).     

Approval was based on a Phase III trail showing that after 12 weeks of treatment, cyclosporine ophthalmic solution 0.09% showed statistically significant improvement in the primary endpoint, Schirmer’s score (a measurement of tear production), compared with vehicle. Improvements in secondary endpoints (i.e. ocular staining assessments) were seen as early as 1 month after initiating treatment.

The solution is dosed twice daily and will be available as a single-use vial.