Sun Pharmaceutical Industries gains FDA approval for CEQUA to treat dry eye disease

Sun Pharmaceutical Industries Ltd. has received approval from the U.S. Food and Drug Administration (FDA) for CEQUA (cyclosporine ophthalmic solution) 0.09%, a significant advancement in the treatment of keratoconjunctivitis sicca, commonly known as dry eye disease. This approval introduces a new therapeutic option for a condition that affects millions worldwide, addressing a substantial unmet medical need.

CEQUA, which features the highest FDA-approved concentration of cyclosporine A (CsA), is the first and only dry eye treatment based on nanomicellar technology. This innovative formulation allows the CsA molecule to overcome solubility challenges, effectively penetrating the eye’s aqueous layer to enhance therapeutic efficacy. The technology ensures the controlled release of the active lipophilic molecule, improving absorption and increasing tear production in patients.

Abhay Gandhi, CEO of North America at Sun Pharma, commented on the breakthrough: “Dry Eye Disease represents an area of high unmet medical need, with a significant number of patients currently untreated. 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 FDA approval of CEQUA was supported by data from a phase 3 confirmatory trial, where the treatment demonstrated statistically significant improvement in tear production as measured by Schirmer’s score after 12 weeks compared to a placebo. Notable improvements were also seen in secondary endpoints, including ocular staining assessments, with some benefits observed as early as one month into the treatment.

CEQUA is recommended to be dosed twice daily and will be available in single-use vials, enhancing convenience and safety for users.

Jodi Luchs, the principal investigator of the CEQUA Phase 3 trial, expressed enthusiasm about the new treatment option: “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. 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.”

With the introduction of CEQUA, Sun Pharma aims to provide a novel and effective solution for patients suffering from dry eye disease, potentially setting a new standard in the management of this chronic condition.