Novaliq has reported positive topline results from its ESSENCE pivotal clinical trial, designed to evaluate the efficacy, safety and tolerability of preservative-free ophthalmic solution CyclASol 0.1% to treat dry eye disease (DED).

The randomised, multi-centre phase IIb/III clinical trial (NCT03292809) enrolled 328 patients.

It evaluated its primary efficacy endpoint at four weeks, with continued dosing for efficacy, as well as safety evaluations, over three months.

For the double-masked, vehicle-controlled trial, patients were enrolled at nine clinical sites in the US.

ESSENCE has been designed to confirm the results of the CYS-002 proof of concept trial. In this, CyclASol demonstrated strong drug effects against the vehicle with high safety and tolerability.

“These results provide pivotal evidence and a clear direction for Novaliq.”

At day 29, the trial met its primary efficacy endpoint of improving corneal fluorescein staining over the vehicle, with high statistical significance (p = 0.0002).

The clinical significance of these outcomes is shown by a high responder rate (>50%) on both corneal and conjunctival staining at four weeks and three months respectively.

OSDI was the second primary endpoint and was tested hierarchically following total corneal fluorescein staining but not powered. It indicated that all patients benefit from the treatment.

The study confirmed the safety and tolerability profile of CyclASol.

Novaliq consulting CMO Gabriela Burian said: “CyclASol 0.1% unfolds the full potential of cyclosporine for the first time in the treatment of DED and demonstrates the superior benefits of our non-aqueous, preservative-free formulation, allowing clinicians to treat more of their patients suffering from DED.

“These results provide pivotal evidence and a clear direction for Novaliq to pursue a timely completion of the clinical development of CyclASol.”