Heidelberg, Germany – January 8, 2018 – Novaliq GmbH, a specialty pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, today announced that it 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. At the air-water interface, the tear film lipid layer (TFLL), which consists of a mixture of lipids and proteins, plays a key role in tear surface tension and is important for the physiological hydration of the ocular surface and for ocular homeostasis1.
The TFLL is impaired in patients with evaporative dry eye caused by Meibomian gland dysfunction (MGD). Currently, treatment options for these patients are limited. NOV03 is designed to immediately stabilize the lipid layer, thereby preventing excessive evaporation of the lipid layer. As NOV03 further penetrates the Meibomian glands, it potentially dissolves Meibomian lipids and eventually helps to improve Meibomian gland functionality. NOV03 may become the first non-blurring, water and surfactant-free treatment to address the medical needs of these patients.
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.
“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 disease1,” said Joseph Tauber, MD, and practicing ophthalmologist at Tauber Eye Center, Kansas City, MO. “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 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.”
Bausch + Lomb and Novaliq Announce Publication of Second Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in American Journal of Ophthalmology NOV03 Consistently Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction NOV03 PDUFA Action Date is June 28, 2023VAUGHAN, Ontario, and HEIDELBERG, Germany, March 22, 2023 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, today announced that American Journal of Ophthalmology has published results from MOJAVE, the second pivotal Phase 3 trial for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Results from the first pivotal Phase 3 trial, GOBI, were published earlier this year in Ophthalmology. The U.S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.
Heidelberg, Germany, and Cambridge, MA, USA, Feb 8, 2023 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced its plans for filing a Marketing Authorisation Application (MAA) for CyclASol® (ciclosporin ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment of dry eye disease (DED) in the European Union.