Phase-IV data shows Cequa helped improve dry eye disease: Sun Pharma

un Pharmaceutical Industries said on Thursday that Phase-IV trial data on its dry eye medication Cequa 0.99 per cent showed sustained improvement in the signs of dry eye disease.

After a drug is approved, researchers look to study the effectiveness of the drug in a wide variety of patients, as well as monitor safety in a large group and enable the development of new uses for the compound. Phase-IV trials are conducted to determine long-term safety and effectiveness and to identify adverse effects that may not have been apparent in prior trials.

Cequa or cyclosporine ophthalmic solution is indicated to increase tear production in patients with dry eye. "In a presentation at the American Academy of Optometry (AAOPT) 2023 annual meeting in New Orleans, La., researchers reported that Cequa elicited significant improvement in corneal fluorescein staining (CFS, a test used to detect damage to the cornea) and in modified Symptom Assessment in Dry Eye (mSANDE) scores in patients with DED whose disease was uncontrolled on Restasis (cyclosporine ophthalmic emulsion) 0.05 per cent therapy," Sun Pharma said in a statement.

 

It was a 12-week Phase-IV multicentre study.

Cequa is the first and only US Food and Drug Administration (FDA)-approved cyclosporine treatment delivered with nanomicellar NCELL technology, which helps to improve the bioavailability of cyclosporine, resulting in improved ocular tissue penetration, the company said.

"We were greatly encouraged to observe significant improvements in dry eye signs and symptoms as early as four weeks into treatment with Cequa, and to see even greater improvements at eight weeks and again at 12 weeks," said lead investigator Josh Johnston, OD, FAAO, of Georgia Eye Partners in Atlanta, Ga.

The study enrolled adults with DED inadequately controlled on current Restasis therapy for at least three months, and who had a history and clinical diagnosis of DED for at least three months before screening/baseline. Patients received one drop of Cequa in each eye twice daily for 12 weeks.