Novaliq has announced results from a pivotal Phase III trial for CyclASol showing improvement in patients with dry eye disease (DED). The positive results, published in the Journal of the American Medical Association Opthalmology, is a milestone for the drug which has a Prescription Drug User Fee Act (PDUFA) action date of June 8, 2023.

Treatment of DED has been dominated by Allergan’s Restasis which was launched in 2003. Recent additions to this therapeutic indication include Novartis’ Xidra and Sun Pharma’s Cequa. Current treatments have been associated with difficulties, however, including slow onset of action and tolerability issues.

According to D. Esen Akpek, MD, professor of ophthalmology at the Wilmer Eye Institute of Johns Hopkins hospital, Baltimore, Massachusetts, corneal staining is one of the most critical parameters of DED. Novaliq’s CyclASol demonstrated noticeable improvements in corneal staining on the National Eye Institute (NEI) scale. The score recorded was an immediately noticeable and clinically meaningful response in dry eye disease therapy.

In the trial, called ESSENCE-2, nearly 72% of patients treated with CyclASol showed a noticeable response after four weeks of treatment. Novaliq says that the rapidity of onset and magnitude of the effect on corneal staining has not been demonstrated in current treatment options.

Novaliq’s compound consists of cyclosporine solubilized in perfluorobutylpentane. It is a water-free solution and negates the requirement for surfactant, oils, or preservative use. Cyclosporine is an immunomodulator that reduces inflammation associate with DED.

“High quality clinical research and scientific communications of the results are key strengths at Novaliq,” said Dr. Christian Roesky, CEO Novaliq. “The breadth and depth of the scientific publications on CyclASol in peer-reviewed journals provide increasing evidence on the clinical value of our water-free technology to address unmet patient and medical needs”.