Bausch + Lomb Presents Data from First Pivotal Phase 3 Trial of Investigational Treatment NOV03 (Perfluorohexyloctane) at the American Society of Cataract and Refractive Surgery Annual Meeting
04/25/2022
NOV03 Met Both Primary Endpoints for Signs and Symptoms of Dry Eye Disease
Dermaliq Therapeutics Signs USD 15 Million Series A Round to Advance Three Transformative Drug Therapies into the Clinics
01/18/2022
- 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
12/21/2021
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
12/16/2021
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
Novaliq receives EU Quality Management Certificate according to new Medical Device Regulation (MDR)
10/12/2021
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.
Bausch + Lomb announces statistically significant Topline Results from the Second Phase 3 Trial of NOV03 (perfluorohexyloctane) in Dry Eye Disease associated with Meibomian Gland Dysfunction
10/01/2021
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.
Novaliq Completes Enrollment of Second Phase 3 Study for CyclASol® for the Treatment of Dry Eye Disease
08/10/2021
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.
New clinical study shows Novaliq NovaTears®+Omega-3 eye drops is a significantly effective treatment for dry eye disease
07/29/2021
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.
Enrollment of second phase 3 trial for NOV03 completed
07/08/2021
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.
Novaliq Announces More than 50% Patients Enrolled in CyclASol® Phase 3 Dry Eye Disease Trial ESSENCE-2
04/28/2021
- 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
Betaliq Initiates Enrollment of Phase 2 Clinical Trial For The Treatment of Glaucoma or Ocular Hypertension
04/20/2021
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.
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
04/13/2021
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, 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)
01/20/2021
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
12/08/2020
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
Bausch Health Initiates Second Phase 3 Study For NOV03 Investigational Treatment For Dry Eye Disease Associated With Meibomian Gland Dysfunction
11/25/2020
LAVAL, Quebec, Nov. 24, 2020 /PRNewswire/ — Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”) and Bausch + Lomb, its leading global eye health business, announced today that the Company has initiated the second of two Phase 3 studies evaluating the investigational treatment NOV03 (perfluorohexyloctane) as a first-in-class investigational drug with a novel mechanism of action to treat the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian gland dysfunction (MGD). Enrollment of the first Phase 3 study is currently underway and has reached 85% of its enrollment goal.
AFT introduces Novatear+Omega-3 eye drop in Australia
10/19/2020
ASX-listed AFT Pharmaceuticals has expanded its therapeutics range with a new dry eye therapy containing Omega-3.
Development Update on CyclASol® Topical Ophthalmic Solution for the Treatment of Dry Eye Disease
07/24/2020
Heidelberg – July 23, 2020 – Novaliq GmbH, a pharmaceutical company focusing on first- and best-in-class ocular therapeutics, today provided a development update on its investigational water-free and preservative-free drug CyclASol®.
Bausch Health licenses Novaliq’s NOV03 investigational treatment for dry eye disease associated with Meibomian gland dysfunction
12/20/2019
LAVAL, Quebec, and HEIDELBERG, Germany, Dec. 20, 2019 – 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).
Season’s Greetings!
12/18/2019
Thank you for your continued commitment. We wish you and your family a happy holiday season and best wishes for a healthy New Year. See you in 2020 ?
Novaliq and Jiangsu Hengrui Medicine announce a strategic collaboration for the investigational products NOV03 and CyclASol® in China
11/08/2019
- Jiangsu Hengrui Medicine secures exclusive rights to develop, manufacture, and commercialize NOV03 and CyclASol® in China.
- NOV03 (perfluorohexyloctane) is a first-in-class investigational drug with a novel mode of action to treat Dry Eye Disease (DED) associated with Meibomian gland dysfunction (MGD).
- CyclASol® (0.1% cyclosporine A in EyeSol®) is an anti-inflammatory and immunomodulating investigational drug developed for the treatment of aqueous deficient DED.
- Novaliq is eligible to receive upfront and milestone payments of up to $165 million plus royalties