CEQUA FDA approval : Sun Pharmaceutical Industries has secured approval for CEQUA (cyclosporine ophthalmic solution) 0.09%, from the US Food and Drug Administration (FDA) to increase tear production in patients having keratoconjunctivitis sicca (dry eye).
According to Sun Pharma, CEQUA is a calcineurin inhibitor immunosuppressant which offers the highest FDA-approved concentration of cyclosporine A (CsA). It is also first and only approved CsA product for dry eye treatment that is based on nanomicellar technology.
The nanomicellar formulation enables the CsA molecule to surpass solubility challenges, penetrate the eye’s aqueous layer and block the release of the active lipophilic molecule before its penetration.
Commenting on CEQUA FDA approval for dry eye treatment, Abhay Gandhi – CEO, North America, Sun Pharma, said: “Dry Eye Disease represents an area of high unmet medical need, with a significant number of patients who are 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.”
CEQUA FDA approval is backed by a phase 3 confirmatory trial in which the Sun Pharma dry eye solution after 12 weeks of treatment demonstrated statistically significant improvement in the primary endpoint, defined to be Schirmer’s score – a measurement of tear production, in comparison to vehicle.
The late-stage trial also showed improvements in secondary endpoints involving ocular staining assessments, which were recorded as early as one month after beginning treatment. CEQUA is indicated to be dosed daily twice for dry eye treatment, said Sun Pharma which will make it available as a single-use vial.
Jodi Luchs, the principal investigator behind the CEQUA confirmatory Phase 3 trial, commenting on CEQUA FDA approval for dry eye treatment said: “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 welcomed news, and I look forward to offering my patients this compelling new option.”
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