MUMBAI, India and PRINCETON, N.J.—Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) has announced that the Food and Drug Administration (FDA) granted approval to its dry eye treatment Cequa (cyclosporine ophthalmic solution) 0.09%. Cequa is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye), according to Sun’s announcement. 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 announcement noted.

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.

“Dry Eye Disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated,” Abhay Gandhi, chief executive officer, North America, Sun Pharma, said in the announcement. “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.”

Jodi Luchs, MD, the principal investigator behind the Cequa confirmatory Phase 3 trial, noted: “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 welcome news, and I look forward to offering my patients this compelling new option.”