Novaliq GmbH
45 articles about Novaliq GmbH
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European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol® (ciclosporin ophthalmic solution) 0.1% for the Treatment of Dry Eye Disease
8/24/2023
Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, announced that the European Medicines Agency has accepted the marketing authorization application for CyclASol for regulatory review.
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CORRECTING and REPLACING Senju Pharmaceutical and Novaliq Enter Into License Agreement For NOV03 (Perfluorohexyloctane Ophthalmic Solution) For the Treatment of Dry Eye Disease in Japan
6/13/2023
Senju Pharmaceutical Co., Ltd. and Novaliq GmbH are pleased to announce the closing of a license agreement on Japan rights to develop, manufacture, and commercialize NOV03, the first and only prescription treatment for signs and symptoms of dry eye disease that directly targets tear evaporation.
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Senju Pharmaceutical and Novaliq Enter Into License Agreement For NOV03 (Perfluorohexyloctane Ophthalmic Solution) For the Treatment of Dry Eye Disease in Japan
6/13/2023
Senju Pharmaceutical Co., Ltd. and Novaliq GmbH are pleased to announce the closing of a license agreement on Japan rights to develop, manufacture, and commercialize NOV03, the first and only prescription treatment for signs and symptoms of dry eye disease that directly targets tear evaporation.
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The regulator’s approval makes Miebo the first DED treatment that directly addresses tear evaporation. The drug is expected to hit U.S. markets in the second half of 2023.
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Novaliq Announces Presentation of New Scientific Data on CyclASol® 0.1% (Cyclosporine Ophthalmic Solution) at the American Society of Cataract and Refractive Surgery Annual Meeting
5/2/2023
Novaliq Announces Presentation of New Scientific Data on CyclASol ® 0.1% (Cyclosporine Ophthalmic Solution) at the American Society of Cataract and Refractive Surgery Annual Meeting.
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Novaliq Announces Publication of Second Pivotal Phase 3 Trial Data on CyclASol 0.1% (Cyclosporine Ophthalmic Solution) in JAMA Ophthalmology
4/12/2023
Novaliq today announced that results from the second pivotal Phase 3 trial for CyclASol®, ESSENCE-2, have been published in Journal of the American Medical Association (JAMA) Ophthalmology.
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Bausch + Lomb and Novaliq Announce Publication of Second Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in American Journal of Ophthalmology
3/22/2023
Bausch + Lomb and Novaliq Announce Publication of Second Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in American Journal of Ophthalmology.
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Bausch + Lomb and Novaliq Announce Publication of Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in Ophthalmology
1/4/2023
Bausch + Lomb and Novaliq Announce Publication of Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in Ophthalmology.
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Novaliq Announces FDA Acceptance of the New Drug Application for CyclASol® for the Treatment of Dry Eye Disease
10/24/2022
Novaliq Announces FDA Acceptance of the New Drug Application for CyclASol ® for the Treatment of Dry Eye Disease.
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Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol®
8/9/2022
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).
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A roundup of last week's top clinical trial updates and news.
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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
4/26/2022
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.
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Dermaliq Therapeutics Signs USD 15 Million Series A Round to Advance Three Transformative Drug Therapies into Clinical Trials
1/18/2022
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.
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Novaliq Announces POSITIVE Topline Results for SECOND PHASE 3 TRIAL (ESSENCE-2) of CyclASol® in Dry Eye Disease
12/21/2021
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).
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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
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.[1].
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It was a busy week for clinical trial news. Here’s a look.
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Bausch + Lomb Completes Enrollment Of Second Phase 3 Study For NOV03 (perfluorohexyloctane)
7/7/2021
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.
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Novaliq Announces More than 50% Patients Enrolled in CyclASol® Phase 3 Dry Eye Disease Trial ESSENCE-2
4/28/2021
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
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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.