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 Presents Data from Second Phase 3 Trial of Investigational Treatment CyclASol® at ASCRS Annual Meeting

Heidelberg, Germany, and Cambridge, MA, USA, April 26, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that data from the second pivotal Phase 3 trial (ESSENCE-2) evaluating the investigational drug CyclASol® for the treatment of dry eye disease (DED), was presented as part of a podium symposium at the American Cataract and Refractive Surgery (ASCRS) annual meeting in Washington D.C. on April 24, 2022.

Bausch + Lomb Presents Data from First Pivotal Phase 3 Trial of Investigational Treatment NOV03 at ASCRS Annual Meeting

VAUGHAN, ON and LAVAL, QC and HEIDELBERG, Germany, April 25, 2022 /PRNewswire/ — Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”), and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that data from the first pivotal Phase 3 trial (GOBI) of NOV03 (perfluorohexyloctane), which is being investigated 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), was presented yesterday as part of a podium presentation on April 24, 2022, at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in Washington, D.C.

Dermaliq Therapeutics Signs USD 15 Million Series A Round to Advance Three Transformative Drug Therapies into the Clinics

  • Dermaliq Therapeutics, Inc. is an independent private pharmaceutical company emerged from Novaliq
  • Spin-off to unlock value in the space of medical dermatology by using Novaliq’s transformative technology outside eye care
  • 3E Bioventures Capital and Beijing Whale Technology Corporation Ltd join as new investors
  • Proceeds will be used for three Phase 1/2a clinical development programs in dermatology

Novaliq Announces Positive Topline Results for Second Phase 3 Trial (Essence-2) of CyclASol® in Dry Eye Disease

Heidelberg, Germany, and Cambridge, MA, USA, December 21, 2021 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced key results of the second pivotal Phase 3 trial (ESSENCE-2) evaluating the investigational drug CyclASol® for the treatment of dry eye disease (DED).

Phase 3 trial of SHR8058 eye drops (perfluorohexyloctane) conducted by Jiangsu Hengrui Pharmaceuticals in the People’s Republic of China shows statistically significant topline results

Heidelberg, Germany, and Cambridge, MA, USA, December 16, 2021 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today provided a development update on the phase 3 trial of SHR8058 eye drops (perfluorohexyloctane) for the treatment of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD) conducted by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”) (SSE: 600276) in the People’s Republic of China showing statistically significant topline results compared to 0.6% sodium chloride solution.1