Novaliq said today that it has begun randomizing patients in a Phase II trial of its product candidate for dry eye disease.
Patients with evaporative dry eye disease caused by Meibomian gland dysfunction have impaired tear film lipid layers, according to the specialty pharma company, and treatment options for these patients are limited. Novaliq’s NOV03 product is designed to stabilize the eye’s lipid layer and prevent excessive evaporation.
As NOV03 gets into the Meibomian glands, the company hypothesizes that it dissolves Meibomian lipids and eventually helps to boost Meibomian gland functionality.
“I’m pleased to be participating in this important study which has the potential to benefit the approximately 16 million diagnosed U.S. Americans who suffer from dry eye disease“ Dr. Joseph Tauber, an ophthalmologist at Tauber Eye Center in Kansas City, said in prepared remarks. “The tear film’s lipid layer is frequently impaired in patients with evaporative dry eye and MGD. A curative therapeutic option that addresses the tear film and is free of water, surfactants, and preservatives, would be greatly welcomed and provide real clinical value to patients and doctors alike.”
“The initiation of this Phase II U.S. trial represents another significant clinical milestone that advances our clinical dry eye program, and moves us a step closer to bringing novel dry eye treatments to market that meet unmet needs,” Sonja Krösser, VP of clinical development, added. “Earlier studies have demonstrated a highly favorable safety and efficacy profile in patients with DED, particularly for evaporative DED and MGD. We are optimistic that we will see similar outcomes in the Seecase Phase II trial.”