Sun Pharma’s novel ophthalmic treatment now TGA approved

Sun Pharma gains TGA approval of novel aqueous, nanomicellar ophthalmic ciclosporin solution, for treatment of moderate-to-severe keratoconjunctivitis sicca (dry eye), where prior use of artificial tears has not been sufficient.

CEQUA’s (ciclosporin 900 microgram/mL) novel delivery system, utilising nanomicellar technology, improves the formulation’s bioavailability and allows for a more than 10-fold increase in the aqueous solubility of ciclosporin.

According to leading Ophthalmologist from Vision Eye Institute, Associate Professor Colin Chan, Sydney, the TGA approval of an additional treatment option for dry eye disease will be welcomed by clinicians and patients alike, given the prevalence of the disease.

“Dry eye affects more than seven (7.4) per cent of the Australian population. The disease represents one of the most common reasons for seeking medical eye care, with a quarter of patients who visit ophthalmic clinics reporting symptoms of dry eye.

“Furthermore, one in five patients with dry eye are dissatisfied with their overall treatment due to lack of symptom relief, the time taken to relieve symptoms, and treatment side-effects,” said A/Prof Chan.

Ciclosporin is the first agent used in the treatment of dry eye to address the pathogenesis of the disease.

“The TGA’s approval of this novel treatment with improved solubility and tissue bioavailability, helps to fulfil a clinically unmet need for dry eye therapies especially for patients who don’t respond to previous therapies,” said A/Prof Chan.

CEQUA is a S4 product and requires a prescription. Sun Pharma is seeking PBS reimbursement for this product.