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 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