Starting today, cyclosporine is no longer synonymous with Restasis for eye doctors, as a second agent in that class was just approved by the FDA. Sun Pharma’s drug Cequa (cyclosporine ophthalmic solution 0.09%), indicated to increase tear production in dry eye patients, joins the ranks of Restasis and Xiidra (lifitegrast) as only the third Rx product approved for this patient population in 19 years.
Cequa's 0.09% concentration of cyclosporine A (CsA) is the highest on the market, and the product includes a unique ‘nanomicellar’ formulation that Sun Pharma says “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.” Micelles are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules, Sun explains in a press release, and the small size of the nanomicelles allows entry into corneal and conjunctival cells, “enabling delivery of high concentrations of CsA.”
In the Phase III confirmatory trial, Cequa showed statistically significant improvement in the primary endpoint of Schirmer’s score (p< 0.01) after 12 weeks of treatment, the company reports. Improvements in secondary endpoints of ocular staining began one month after initiating treatment, the company adds.
Cequa is dosed twice daily and will be available as a single-use vial. It will be commercialized in the US by Sun Ophthalmics, the company’s branded ophthalmics division.