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sun pharma

Sun Pharma gets USFDA approval for its novel Dry Eye treatment drug

Sun Pharma has received USFDA approval for its novel drug Cequa. This novel drug is indicated to in the treatment of dry eye. The drug increases tear production in patients with dry eye.

Cequa (cyclosporine A, ophthalmic solution) is a patented, novel, proprietary nanomicellar formulation of cyclosporine A, 0.09% in a clear, preservative-free, aqueous solution. Company claims that Cequa has the highest FDA-approved concentration of cyclosporine A (CsA) and it is the first and only approved CsA product that incorporates a nanomicellar technology.

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.

In the Phase 3 trials, Cequa showed statistically significant improvement in the primary endpoint after 12 weeks of treatment while the improvements in secondary endpoints were seen as early as 1 month in the treatment. Cequa is dosed twice daily and will be available as a single-use vial.

Dry Eye Disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated. The USFDA approval of Cequa represents a long-awaited dry eye treatment option and is an important milestone for Sun’s Ophthalmics business.

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