Novaliq Announces First Patient Enrolled in Its SEECASE Phase 2 Trial of NOV03 for the Treatment of Dry Eye Disease

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).

  • Commencement of SEECASE Trial Marks Second Late-Stage Clinical Program in the U.S.
  • Top Line Data Expected Second Half 2018
  • NOV03 is Specifically Designed for Patients with Evaporative Dry Eye Disease Caused by Meibomian Gland Dysfunction

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.


Source:

  1. Garrigue Jean-Sébastien, Amrane Mourad, Faure Marie-Odile, Holopainen Juha M., and Tong Louis. Journal of Ocular Pharmacology and Therapeutics. November 2017, 33(9): 647-661. https://doi.org/10.1089/jop.2017.0052]

Novaliq Announces More than 50% Patients Enrolled in CyclASol® Phase 3 Dry Eye Disease Trial ESSENCE-2

  • Topline results expected in 2nd half 2021; 475 out of a 834 target patients randomized in ESSENCE-2
  • Enrollment for 12-month safety extension trial (ESSENCE-2 OLE) completed
  • Phase 2B/3 Trial ESSENCE-1 Published in Cornea: The Journal of Cornea and External Disease
Heidelberg and Cambridge, MA – April 28, 2021 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that the second Phase 3 clinical trial evaluating CyclASol® to treat the signs and symptoms of dry eye disease (DED) has randomized more than 50% out of 834 targeted patients, with top-line results expected in the 2nd half of 2021.

Betaliq Initiates Enrollment of Phase 2 Clinical Trial For The Treatment of Glaucoma or Ocular Hypertension

Betaliq Initiates Enrollment of Phase 2 Clinical Trial Investigating BTQ-1901-A, BTQ 1901 B and BTQ-1902 For The Treatment of Glaucoma or Ocular Hypertension
TAMPA, FL, UNITED STATES, April 20,2021 /EINPresswire.com/ — Betaliq, Inc., a clinical-stage ophthalmic company focused on developing therapies for the treatment of glaucoma, today announced enrollment of the first subject in their Phase 2 clinical trial. Betaliq’s pipeline consists of two preservative-free and water-free glaucoma drug candidates based on Novaliq GmbH’s EyeSol® technology. EyeSol is the worldwide first and only water-free technology for topical ophthalmology products. Two EyeSol based ophthalmic products are currently approved in Europe and Australia and two active INDs are in late-stage development in the United States.

Partner Bausch + Lomb Announces Statistically Significant Topline Results from the First Phase 3 Trial of NOV03

All Primary and Secondary Endpoints Were Achieved
LAVAL, Quebec, and HEIDELBERG, Germany, April 13, 2021 – Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”), and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced statistically significant topline data from the first Phase 3 trial (GOBI trial) evaluating the investigational drug NOV03 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD).

Bausch + Lomb Completes Enrollment of first Phase 3 Study for Nov03 (perfluorohexyloctane)

LAVAL, Quebec, and HEIDELBERG, Jan. 20 2021 – Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) and Bausch + Lomb, its leading global eye health business, and Novaliq GmbH, a pharmaceutical company focusing on first- and best-in-class ocular therapeutics, announced today that Bausch Health has acquired an exclusive license for the commercialization and development in the United States and Canada of the investigational treatment NOV03 (perfluorohexyloctane), a first-in-class investigational drug with a novel mechanism of action to treat Dry Eye Disease (DED) associated with Meibomian gland dysfunction (MGD).

Novaliq Announces First Patient Randomized in the Phase 3 trial ESSENCE-2 of CyclASol® Topical Ophthalmic Solution for the Treatment of Dry Eye Disease

Novaliq Announces First Patient Randomized in the Phase 3 trial ESSENCE-2 of CyclASol® Topical Ophthalmic Solution for the Treatment of Dry Eye Disease
  • ESSENCE-2 is the second registration trial to complete the clinical development of CyclASol® as agreed with U.S. Food and Drug Administration (FDA)
  • Designed to replicate efficacy demonstrated in previous phase 2/3 ESSENCE-1 trial
  • Topline data expected in 2nd half 2021