Sun Pharma gets FDA nod for Cequa's dry eye treatment
Sun Pharmaceutical Industries has received the FDA green light for Cequa (cyclosporine ophthalmic solution) 0.09%, it announced Thursday.
Cequa is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye)and is the first and only approved CsA product that incorporates a nanomicellar technology, according to the company.
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.
“Dry eye disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated,” Sun Pharma CEO North America Abhay Gandhi, said in a press statement. “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.”
The product will be commercialized by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary.
Cequa is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye)and is the first and only approved CsA product that incorporates a nanomicellar technology, according to the company.
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.
“Dry eye disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated,” Sun Pharma CEO North America Abhay Gandhi, said in a press statement. “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.”
The product will be commercialized by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary.