36 articles with Novaliq GmbH
Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol®
Novaliq, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for CyclASol® (cyclosporine ophthalmic solution), a proposed novel treatment for the signs and symptoms of dry eye disease (DED).
A roundup of last week's top clinical trial updates and news.
NOVALIQ PRESENTS DATA FROM SECOND PHASE 3 TRIAL OF INVESTIGATIONAL TREATMENT CYCLASOL® (0.1% CYCLOSPORINE OPHTHALMIC SOLUTION) AT THE AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY ANNUAL MEETING
Novaliq 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.
Dermaliq Therapeutics Signs USD 15 Million Series A Round to Advance Three Transformative Drug Therapies into Clinical Trials
Novaliq GmbH, 3E Bioventures Capital and Beijing Whale Technology Corporation Ltd. announced the establishment of Dermaliq Therapeutics, Inc, a newly formed Delaware-based pharmaceutical development company, and the signing of a USD 15 million Series A financing round.
Novaliq Announces POSITIVE Topline Results for SECOND PHASE 3 TRIAL (ESSENCE-2) of CyclASol® in Dry Eye Disease
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
Novaliq provided a development update on the phase 3 trial of SHR8058 eye drops for the treatment of dry eye disease associated with Meibomian gland dysfunction conducted by Jiangsu Hengrui Pharmaceuticals Co., Ltd. in the People's Republic of China showing statistically significant topline results compared to 0.6% sodium chloride solution..
10/11/2021Another busy week for clinical trial news. Here’s a look.
It was a busy week for clinical trial news. Here’s a look.
Bausch + Lomb and Novaliq GmbH announced the second of two Phase 3 studies evaluating the investigational drug NOV03 as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease associated with meibomian gland dysfunction, has been completely enrolled with a total of 622 participants.
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
The company launched with $6 million in equity funding, which is still open. Betaliq has two compounds in its pipeline, both which use Novaliq’s waterfree EyeSol technology for ophthalmology products.
Novaliq and BLP Management Group Established New Company, Betaliq Inc., to Leverage EyeSol Technology to Treat Glaucoma
Novaliq GmbH, a specialty pharmaceutical company for the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol® and BLP Management group announce the formation and funding of Betaliq Inc., a new company located in Tampa, Florida.
Novaliq named Finalist in “Clinical Trial Result of the Year” category of the Clinical & Research Excellence Awards CARE 2019
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
Novaliq Announces Positive Topline Results for Its SEECASE Phase 2 Trial of NOV03 for the Treatment of Patients with Dry Eye Disease
The SEECASE trial met its prespecified primary endpoint for both treatment schedules at 8 weeks
Novaliq Announces Positive Topline Results for Its CyclASol® Phase 2B/3 Essence Trial in Patients with Dry Eye Disease
The ESSENCE trial met its primary endpoint at 4 weeks and demonstrated superiority of CyclASol® over vehicle in change from baseline on corneal fluorescein staining
Novaliq Raises New Capital to Accelerate the Commercialization of its Lead Products for Dry Eye Disease
Focus on clinical development and to prepare commercialization of CyclASol® and NOV03
As an emerging leader in the field of ophthalmology, Novaliq is currently pursuing two late-stage clinical trials in the United States.
Novaliq Announces First Patient Enrolled in Its SEECASE Phase II Trial of NOV03 for the Treatment of Dry Eye Disease
Novaliq announced that it has begun randomization of patients in its SEECASE Phase 2 clinical trial for the treatment of dry eye disease (DED).
Novaliq’s NovaTears+Omega-3 Approved in Europe for the Enhanced Treatment of Evaporative Dry Eye Disease
NovaTears+Omega-3 is a technological breakthrough in the treatment of DED.
Novaliq Announces First Patient Randomized in Its ESSENCE Phase 2b/3 Trial of CyclASol for the Treatment of the Signs and Symptoms of Dry Eye Disease
CyclASol potentially overcomes the current intolerability and efficacy profiles due to the benefits of a water-free vehicle and the mechanism of drug delivery.