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]

NOV03 Consistently Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction

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, 2023

VAUGHAN, 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.

Jiangsu Hengrui Pharmaceuticals’ Marketing Authorization Application for Innovative Drug SHR8058 (Perfluorohexyloctane) for the Treatment of Dry Eye Disease has been accepted in the People’s Republic of China

February 2, 2023. Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”), received the “Notice of Acceptance” from the Chinese National Medical Products Administration (NMPA). The marketing authorization application for SHR8058 (perfluorohexyloctance) eye drops was accepted for the treatment of dry eye disease associated with Meibomian gland dysfunction by NMPA.

Novaliq Plans to File a Marketing Authorisation Application for CyclASol® in the E.U. for the treatment of Dry Eye Disease in July 2023

  • CHMP determined CyclASol is eligible for a centralised procedure
  • Novaliq has submitted a Letter of intent to file a Marketing Authorisation Application (MAA) in July 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.

Bausch + Lomb and Novaliq Announce Publication of Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in Ophthalmology

NOV03 is Being Investigated to Treat the Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction NOV03 PDUFA Action Date is June 28, 2023 VAUGHAN, Ontario, and HEIDELBERG, Germany, Jan. 4, 2023 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in class ocular therapeutics, today announced that Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, has published results from the pivotal Phase 3 trial GOBI, which is one of two pivotal Phase 3 trials for NOV03 (perfluorohexyloctane).

Sonja Kroesser named Top 25 Women Leaders in Biotechnology of 2022

Heidelberg, Germany, and Cambridge, MA, USA, November 15, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, is proud to announce that today our own Sonja Kroesser, Vice President and Head of Preclinical and Clinical Development, was named as a Top 25 Women Leaders in Biotechnology of 2022 by the Healthcare Technology Report.