August 17, 2018
The US Food and Drug Administration (FDA) has approved cyclosporine A ophthalmic solution 0.09% (Cequa, Sun Pharmaceuticals) to increase tear production in patients with keratoconjunctivitis sicca (dry eye), the company has announced.
Cequa is a patented, novel, proprietary nanomicellar formulation of cyclosporine A, 0.09% in a clear, preservative-free, aqueous solution.
"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 company said in a news release. "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."
Cequa was assessed in a phase 3 confirmatory study involving 744 patients with dry eye who were treated with Cequa or its vehicle. After 12 weeks of treatment, Cequa led to a statistically significant improvement in the primary endpoint, Schirmer's score (a measurement of tear production; P < .01) compared with vehicle.
Improvements in ocular staining assessments (secondary endpoints) were evident as early as 1 month after starting treatment. Cequa is dosed twice daily and will be available as a single-use vial, the company said.
In a prior phase 2b/3 clinical trial with 455 patients, Cequa demonstrated increased tear production (P < .01) and was well tolerated. Several key secondary endpoints also showed statistically significant improvements compared with vehicle.
The most common adverse reaction following the use of cyclosporine ophthalmic solution 0.09% was instillation site pain (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of the patients were eye irritation, blepharitis, urinary tract infection, headache, and bronchitis.
Cequa should not be administered while patients are wearing contact lenses, according to the company.
Dry eye disease is a chronic disease affecting upward of 16 million people in the United States alone.
"Dry eye is a complex disease that lacks a 'one-size-fits-all' approach," Jodi Luchs, MD, who led the confirmatory study, said in the news release. "As a clinician treating a high volume of dry eye patients, it's important to have multiple treatment modalities available at my disposal. Given its strong clinical trial performance, the approval of Cequa is welcomed news, and I look forward to offering my patients this compelling new option."