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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
2023-06-13
·
BioSpace
临床3期
引进/卖出
上市批准
临床结果
OSAKA, Japan & HEIDELBERG, Germany & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Senju Pharmaceutical Co., Ltd.
, a researched-based Japanese pharmaceutical company focusing the field of ophthalmology, and
Novaliq GmbH
, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on its unique EyeSol® water-free technology, are pleased to announce the closing of a license agreement on Japan rights to develop, manufacture, and commercialize
NOV03
(
perfluorohexyloctane
ophthalmic solution), the first and only prescription treatment for signs and symptoms of
dry eye disease
that directly targets tear evaporation. “We are thrilled to collaborate with
Novaliq
as a pioneer for cutting edge water-free eye drop technology. On the basis of very unique features and unparalleled clinical data of NOV03, we strongly believe that it will provide huge clinical benefits to Japanese patients”, said Shuhei Yoshida, President of
Senju Pharmaceutical
. NOV03 is a first-in-class, preservative-free treatment for signs and symptoms of
dry eye disease
. Its unique mode of action directly targets tear evaporation by forming a monolayer at the air-liquid interface of the tear film.
NOV03
has demonstrated safety and efficacy in the indication in multiple, adequately controlled studies in patients with a history of
dry eye disease
and clinical signs of Meibomian gland dysfunction. In Japan, potentially more than 5 million patients are diagnosed with
dry eye disease
[1] and current treatment options addressing
evaporative dry eye disease
or
dry eye
associated with clinical signs of Meibomian gland dysfunction are limited. “We are proud to partner with
Senju Pharmaceutical
, a leading ophthalmic company in Japan, to bring NOV03 to patients in Japan”, said Dr. Christian Roesky, CEO,
Novaliq
. “
NOV03
offers a new and unique mode of action and is clinically validated. Its safety and efficacy has been demonstrated in numerous studies in Europe, United States and China. With approximately 10 million units sold in Europe and Australia since its launch in 2015, our water-free EyeSol® technology is proven to be safe and well accepted”. Under the terms of the license agreement,
Novaliq
Novaliq
is eligible to receive upfront and milestone payments contingent upon the achievement of regulatory and sales milestones as well as royalties on net sales of
NOV03
in Japan. About NOV03 (
perfluorohexyloctane ophthalmic solution
) NOV03 (
perfluorohexyloctane
ophthalmic solution) is a water-free, preservative-free eye drop being developed as a treatment for patients with
dry eye disease
associated with Meibomian gland dysfunction. It has a novel mode of action to stabilize the tear film lipid layer and thereby protects from excessive evaporation. In addition, it has been shown to penetrate into the Meibomian glands and potentially liquify altered secretions. Four adequate and well controlled studies have demonstrated that
NOV03
improves the signs and symptoms of
dry eye disease
in patients with clinical signs of Meibomian gland dysfunction and is very well tolerated [2-5].
NOV03
is a
Food and Drug Administration (FDA)
approved drug therapy in the USA for the treatment of the signs and symptoms of
dry eye disease
and in NDA review in China. About
Senju Pharmaceutical
Senju
is a privately held, research-based Japanese pharmaceutical company that develops, manufactures, and commercializes a variety of innovative products, focusing on the field of ophthalmology to improve the health and quality of vision for people worldwide through the company’s products. The characters that comprise
Senju
's company name in Japanese language are "Sen" and "Ju“, or "thousand" and "bringing happiness".
Senju
's mission is to improve the joy of living of people associated with the company through the development of original pharmaceutical products.
Senju
is headquartered in Osaka, Japan and has its subsidiaries and representative offices around the world. More on . About
Novaliq
Novaliq
is a private biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology, using ultrapure semifluorinated alkanes (SFAs) that are physically, chemically, and physiologically inert with excellent biocompatibility and a very good safety profile. On May 18th, 2023, U.S. FDA approved
MIEBO
™ (
perfluorohexyloctane
ophthalmic solution; formerly known as
NOV03
) followed by the approval of
VEVYE
™ (
cyclosporine
ophthalmic solution, development name
CyclASol
®) 0.1% on May 30th, 2023. In the EU,
perfluorohexyloctane
is registered as a medical device to treat patients with
dry eye disease
since 2013. The company continues to progress into other ophthalmic indications based on its validated EyeSol® platform.
Novaliq GmbH
is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is
dievini Hopp BioTech holding GmbH & Co. KG
, an active investor in Life and Health Sciences companies. More on . Recommended Readings Global Data.
Dry Eye Syndrome
: Seven-Market Drug Forecast and Market Analysis Update | December 2022 Tauber J, Wirta DL, Sall K, Majmudar PA, Willen D, Krösser S; SEECASE study group. A Randomized Clinical Study (SEECASE) to Assess Efficacy, Safety, and Tolerability of
NOV03
for Treatment of
Dry Eye Disease
. Cornea. 2021 Sep 1;40(9):1132-1140 Tian L, Gao Z, Zhu L, Shi X, Zhao S, Gu H, Xu G, Wang L, Dai H, Zhang H, Jin X, Ma K, Xu Y, Ma L, Pei C, Ke B, Krösser S, Zhang Y, Jie Y.
Perfluorohexyloctane
Eye Drops for
Dry Eye Disease
Associated With Meibomian Gland Dysfunction in Chinese Patients: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Apr 1;141(4):385-392 Tauber J, Berdy GJ, Wirta DL, Krösser S, Vittitow JL; GOBI Study Group. NOV03 for
Dry Eye Disease
Associated with Meibomian Gland Dysfunction: Results of the Randomized Phase 3 GOBI Study. Ophthalmology. 2023 May;130(5):516-524 Sheppard JD, Kurata F, Epitropoulos AT, Krösser S, Vittitow JL; MOJAVE STUDY GROUP. NOV03 for Signs and Symptoms of
Dry Eye Disease
Associated With Meibomian Gland Dysfunction: the Randomized Phase 3 MOJAVE Study: NOV03 for
Dry Eye Disease
Associated With Meibomian Gland Dysfunction (69 characters; limit, 60). Am J Ophthalmol. 2023 Mar 20: S0002-9394(23)00098-3 Any product/brand names and/or logos are trademarks of the respective owners. © 2023
Novaliq GmbH
, Heidelberg, Germany. View source version on businesswire.com: Contacts
Novaliq
Media Contact: Simone Angstmann-Mehr info@novaliq.com
Senju
Media Contact:
Senju Communications
cc@senju.co.jp Source:
Novaliq GmbH
View this news release online at:
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文中所述内容并不反映新药情报库及其所属公司任何意见及观点,如有版权侵扰或错误之处,请及时联系我们,我们会在24小时内配合处理。
机构
dievini Hopp BioTech holding GmbH & Co. KG
US Food & Drug Administration
Senju-USA, Inc.
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