It addresses a ‘high unmet medical need.’
The U.S. Food and Drug Administration has approved Cequa, a drug intended to increase tear production in patients with dry eye.
Cequa (cyclosporine ophthalmic solution) 0.09% is dosed twice daily and will be available as a single-use vial, according to a press release from Sun Pharmaceutical Industries Ltd.
“Dry Eye Disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated,” said Abhay Gandhi, CEO, North America, Sun Pharma. “The U.S. FDA approval of Cequa represents a long-awaited dry eye treatment option and is an important milestone in the development of Sun’s Ophthalmics business. Cequa, with its novel nanomicellar formulation for a proven dry eye medication, delivers a lipophilic molecule in a clear solution form.”
Cequa will be commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary.
Jodi Luchs, MD, the principal investigator behind the Cequa confirmatory Phase 3 trial, said: “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. 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 drug “provides the highest FDA-approved concentration of cyclosporine A (CsA) and is the first and only approved CsA product that incorporates a nanomicellar technology,” according to the release.