Heidelberg, Germany-based pharmaceutical company Novaliq GmbH has begun randomization of patients in its SEECASE Phase 2 clinical trial for the treatment of dry eye disease (DED).
DED is a multifactorial and complex disease of the ocular surface. An interface of lipids and proteins, known as the tear film layer (TFLL), is important for physiological hydration of the ocular surface and for ocular homeostasis. The TFLL is impaired in patients with evaporative dry eye caused by Meibomian gland dysfunction. The trial drug NOV03 is thus designed to immediately stabilize the lipid layer, preventing its excessive evaporation.
NOV03 works by penetrating the Meibomian glands, where it potentially dissolves Meibomian lipids and eventually helps to improve the gland functionality. NOV03 may become the first non-blurring, water and surfactant-free treatment to address the medical needs of these patients.
“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,” says Joseph Tauber, MD, practicing ophthalmologist at Tauber Eye Center, Kansas City, MO.
Novaliq’s SEECASE clinical trial (NCT 03333057) is a phase 2, multi-center, randomized, double-masked, saline-controlled study to evaluate the effect of NOV03 at two different dosing regimens on signs and symptoms of DED. NOV03 will be studied in two dosing regimens, two and four instillations per day.
“The initiation of this phase 2 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,” says Sonja Krösser, PhD, VP Clinical Development at Novaliq GmbH. “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 2 trial.”
See the full press release from Novaliq.