Press Releases

Heidelberg, Germany, October 12, 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 it has implemented and applies a quality management system in accordance with Annex IX, Chapter I of the EU Medical Device Regulation (MDR), for conformity assessment of its medical devices NovaTears^®, NovaTears^®+Omega-3 and EvoTears™ OMEGA.

LAVAL, QC and HEIDELBERG, Germany, Sept. 30, 2021 – Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) and Novaliq GmbH (“Novaliq”), a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced statistically significant topline data from the second Phase 3 (MOJAVE) 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). The companies announced statistically significant topline data from the first Phase 3 trial (GOBI trial) in April 2021.

Heidelberg, Germany, and Cambridge, MA, August 10, 2021 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol^® water-free technology, today announced the second of two Phase 3 (ESSENCE-2) studies, evaluating the investigational drug CyclASol^® to treat the signs and symptoms of dry eye disease DED, has been completely enrolled with a total of 834 participants.

NovaTears^®+Omega-3, an innovative dry eye treatment in-licensed and distributed in Australia and New Zealand by AFT Pharmaceuticals, is a significantly effective treatment for evaporative Dry Eye Disease (DED), a new clinical study¹ has found.

LAVAL, QC and HEIDELBERG, Germany, July 7, 2021 /PRNewswire/ — Bausch + Lomb, a leading global eye health business of BauschHealth Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”), and Novaliq GmbH, a biopharmaceutical companyfocusing on first- and best-in-class ocular therapeutics, today announced the second of two Phase 3 (MOJAVE) studies evaluating theinvestigational drug NOV03 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs andsymptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD), has been completely enrolled with a total of622 participants.

• 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 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.

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).

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

• 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 2^nd half 2021