Novaliq named Finalist in “Clinical Trial Result of the Year” category of the Clinical & Research Excellence Awards CARE 2019

  • Novaliq is recognized for its SEECASE clinical trial results of NOV03 demonstrating unprecedented sign and symptom improvements for Dry Eye Disease (DED) patients while offering an excellent safety profile
  • NOV03 is potentially the first drug targeting the key underlying cause of evaporative DED, the leading reason for this undertreated disease that impacts visual function

Heidelberg – February 26, 2019 – Novaliq, the pharmaceutical company for the development and commercialization of first- and best-in-class ocular therapeutics based on the water-free EyeSol® technology, has been named a finalist in “Clinical Trial Result of the Year” category of the CARE Awards, which recognizes outstanding work across the global clinical research enterprise.

In 2018, Novaliq conducted the SEECASE trial which enrolled 336 patients at ten clinical sites in the United States and published topline data in October 2018. SEECASE was a phase 2, multi-center, randomized, double-masked, controlled clinical trial (NCT03333057) and was designed to evaluate the effects of two dosing regimens of NOV03 on signs and symptoms of Dry Eye Disease (DED). The trial results showed that NOV03 effectively improved both clinical signs of ocular health and patient-reported symptoms, with a fast onset of action, in patients with DED associated with MGD.

NOV03 is a potential breakthrough therapy for DED patients based on its novel mode of action. NOV03 stabilizes the lipid layer of the tear film and thereby prevents excessive tear evaporation, and also penetrates meibomian glands, potentially dissolving thickened meibum to improve meibomian gland function.It is therefore the first time that a drug addresses the underlying cause of evaporative DED.

Based on the unprecedented findings from the SEECASE trial, Novaliq has accelerated its development program to achieve regulatory approval and drug availability on the market soon. The final pivotal clinical trial is expected to start in 2019, leading to the NDA filing in 2021.

The CARE Awards 2019 features 11 categories, significant accomplishments and highlight innovation across the industry – from rare diseases drug development and patient centricity in trials and research, to product and technological development, clinical results and collaborative efforts between individuals, departments, or companies. Entries are judged independently by a panel of experts from all core sectors of the clinical R&D industry.

“We are thrilled to be selected as one of three finalists for the clinical trial results of the SEECASE trial and thus be acknowledged for the dedicated work of Novaliq’s clinical development team lead by Sonja Krösser, PhD, VP Preclinical & Clinical Development. This worldwide recognition of the trial outcomes is reflecting the high potential of NOV03 eye drops to impact the lives of many untreated patients suffering from dry eye disease and further supports Novaliq’s strategy to accelerate the last phase of development,” said Gabriela Burian MD, Consulting Chief Medical Officer at Novaliq.

The 2019 winners will be announced at a ceremony on Thursday, May 2ndat the Hyatt Regency Boston, MA, where distinguished leaders in the biopharmaceutical, CRO, and diagnostic industries gathered from all corners of the globe.

You can view the full list of finalists here: https://pharmaintelligence.informa.com/events/awards/care-awards-2019/shortlist

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