FDA OKs new dry eye treatment

Sun Pharmaceuticals announced the approval of their novel cyclosporine A formulation for increasing tear production in patients with dry eye disease.

Cequa contains the highest approved concentration of cyclosporine A (0.09%) to date and uses a nanomicellar technology to improve solubility and facilitate the drug’s entry into corneal and conjunctival cells. The clear aqueous eye drop is dosed twice daily and will be available in single-use vials, according to the press release.

“Dry eye is a complex disease that lacks a ‘one-size-fits-all’ approach. As a clinician treating a high volume of dry eye patients, it’s important to have multiple treatment modalities available at my disposal,” said Jodi Luchs, MD, principal investigator of the phase 3 trial. “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.”

The phase 3 confirmatory study enrolled 744 patients with dry eye who were treated with Cequa or vehicle. After 12 weeks of treatment, the drug met its primary endpoint with a statistically significant improvement in Schirmer's score compared with vehicle (P<0.01). Improvements in ocular staining assessments were evident about 1 month after starting treatment.

Common adverse reactions associated with use of Cequa were instillation site pain (22%) and conjunctival hyperemia (6%).

The eye drop will be will be marketed in the U.S. by Sun Pharma’s eyecare division, Sun Ophthalmics.