Sun Pharma Receives FDA Approval for Dry Eye Drug
Friday, August 17, 2018 12:21 AM
MUMBAI, India, PRINCETON, N.J.—Sun Pharmaceutical Industries
(Reuters: SUN.BO) has received approval for its dry eye drug, CEQUA (cyclosporine ophthalmic solution) 0.09 percent, from the U.S. Food and Drug Administration (FDA). CEQUA is indicated to increase tear production in patients with keratoconjunctivitis sicca, or dry eye. 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, according to Sun Pharmaceuticals. The 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, the company said.
“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.