Novaliq’s NovaTears®+Omega-3 Approved in Europe for the Enhanced Treatment of Evaporative Dry Eye Disease
Novaliq GmbH, a specialty pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, today announced the European registration of NovaTears®+Omega-3 for the enhanced treatment of the signs and symptoms of evaporative dry eye disease (DED).
NovaTears®+Omega-3 is a technological breakthrough in the treatment of DED. Using Novaliq’s proprietary, water-free EyeSol® drug delivery technology, NovaTears®+Omega-3 is the first eye drop containing high concentrations of Omega-3 (0.2%) ethyl ester of plant origin. Previously unattainable, the treatment is available in a convenient multi-dose bottle, demonstrating both superior stability at room temperature and the enabling properties of Novaliq’s water-free platform technology.
NovaTears®+Omega-3 stabilizes the lipid layer of the tear film and reduces the evaporation of the underlying water phase of the tear film and supplements the lipid layer with essential Omega-3 fatty acids. The outer layer of the natural tear film, the lipid layer, protects the tear film against evaporation. It contains a mixture of cholesterol, fatty acids, phospholipids and waxes. To stabilize the tear film in case of impairment and to reduce tear evaporation, the lipid layer can be supplemented by externally applied fatty acids. Ideally these fatty acids should be of natural origin and be present in the human body to minimize the risk of local intolerances.
NovaTears® is the first, clinically proven lipid layer stabilizer that improves signs and symptoms in patients with DED without causing vision blurring. With the addition of Omega-3 fatty acid, this effect can be further enhanced. Until now Omega-3 fatty acids could only be reliably supplemented through diets (e.g. fish) or balanced nutrition.
“It is well-known that dry eye disease compromises the lipid layer of the tear film, which, in healthy eyes, protects the tear film against evaporation,” says Jerry Cagle, PhD, Former Chief Scientific Officer of Alcon, and member of Novaliq’s Supervisory Board. “The addition of Omega-3 fatty acids to an already powerful NovaTears® eye drop will provide dry eye patients with additional relief and physiological benefits by stabilizing the lipid layer. This will be a welcome and much-needed addition to ophthalmologists’ arsenal of DED products in Europe.”
“NovaTears® as the first and only treatment specifically designed to treat evaporative DED provides high efficacy and great comfort to patients,” says Bernhard Günther, Founder and Chief Innovation Officer, Novaliq GmbH. “The therapeutic benefits of combining these qualities with those of Omega-3 fatty acids offer further advantages. I am confident that all dry eye patients will greatly benefit from this breakthrough innovation."
About the Tear Film, Omega-3 Fatty Acids and NovaTears®
The outer layer of the tear film—the lipid layer—protects the tear film against evaporation and contains a mixture of cholesterol, fatty acids, phospholipids and waxes. To stabilize the tear film in cases of impairment, e.g. by meibomian gland dysfunction (MGD), and to reduce tear evaporation, the lipid layer can be supplemented by externally applied fatty acids ideally of natural origin to minimize the risk of ocular intolerability. Omega-3 supplements have been widely known and accepted in eye care for many years. A recent study reported that dry eye patients with MGD show a decrease of polyunsaturated fatty acids in the tear film1. These patients should clearly benefit from the supplementation with naturally occurring omega-3 fatty acids.
NovaTears® is already clinically proven to be a lipid layer stabilizer. With the addition of Omega-3 fatty acids, this effect can be further enhanced. Until now Omega-3 fatty acids could only be reliably supplemented by following a well-balanced diet rich in foods containing Omega-3 fatty acids such as fish. NovaTears® efficacy and safety have been clinically validated by 4 prospective, post-market studies. Post-market clinical studies with NovaTears®+Omega-3 are planned for 2018.
About Novaliq – Novaliq GmbH, founded in 2007, is a Heidelberg based specialty pharmaceutical company focused on ophthalmology. Its mission is to transform poorly soluble drugs into effective ocular therapeutics for both the front and the back of the eye. Novaliq’s proprietary EyeSol® technology enhances the topical bio-availability, stability and safety of traditionally insoluble or unstable drugs improving the delivery, efficacy and convenience of treatments for ocular surface diseases including dry eye through preservative free and multi dose formulations. Novaliq has developed a tiered and long-term sustainable dry eye family of truly differentiated products that addresses the different needs of dry eye patients. Novaliq’s most advanced product is NovaTears® with CE-approval marketed under the brand name EvoTears® in Europe. CyclASol® a second-generation prescription drug is currently in preparation for a pivotal trial. More on www.novaliq.com.
1. Suzuki, Tomo; Fujiwara, Satoshi; Maekawa, Megumi; Nagase, Midori; Yamamoto, Yorihiro; Kinoshita, Shigeru. “Fatty acid composition and lipid hydroperoxide in the meibum of patients with Meibomian gland dysfunction.” Investigative Ophthalmology & Visual Science, June 2015, Vol.56, 4474.
# # #
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
American Airlines Announces Nonstop Philadelphia (PHL) to Orlando Melbourne (MLB)22.9.2018 01:13 | Tiedote
Glorious beaches by day and theme park fireworks by night just got more convenient for Philadelphia travelers. American Airlines announced today that it will begin nonstop flights to Orlando Melbourne International Airport (MLB) starting February 16, 2019. The Central Florida airport is conveniently located in the heart of the tourism region and is the closest airport to NASA rocket launches, Port Canaveral’s cruises and what critics call “some of the most beautiful beaches Florida has to offer.” The flights will depart Saturdays from Philadelphia at 8:05 a.m., arriving in Florida at 10:48 a.m. The Embraer 175 jet arrival time syncs perfectly with cruise ship noon early boarding. Melbourne Airport Express offers nonstop shuttle service to the port, and all major rental car companies are onsite. The return flight to PHL departs at 11:24 a.m. and arrives in PHL at 1:55 p.m., with enough time to connect to some of American’s largest international destinations, including recently announced
Amy Palladino Joins BCW as Executive Vice President, Managing Director, Corporate Practice21.9.2018 20:43 | Tiedote
BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced that Amy Palladino has joined the agency as Executive Vice President, Managing Director in the agency’s U.S. Corporate Practice. Based in New York, Palladino will focus on senior client counsel and executive positioning for the agency’s largest corporate clients. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005507/en/ Amy Palladino Joins BCW (Burson Cohn & Wolfe) “Amy is a talented and highly experienced communications executive with a track record of solving clients’ complex challenges and building business through smart, integrated communications approaches,” said Chris Foster, President, North America, BCW. “Her creativity and judgement will be enormously valuable to our current and prospective clients.” Palladino has more than 20 years of experience advising global clients across numerous industries, including technology, healthcar
Heidelberg Engineering Announces the CE-Marking of ANTERION21.9.2018 19:41 | Tiedote
Heidelberg Engineering, the leader in diagnostic imaging known for the internationally-acclaimed SPECTRALIS ® retina and glaucoma platform, announces the CE-marking of ANTERION ® – an innovative platform designed to transform anterior segment diagnostics and workflow. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005442/en/ The new Heidelberg Engineering ANTERION® provides the most important anterior segment examinations and measurements in one modular, upgradeable platform. (Graphic: Business Wire) The new ANTERION provides the most important anterior segment examinations and measurements in one modular, upgradeable platform. It is a single, workflow-efficient solution that brings together corneal topography and tomography, anterior segment metrics, axial length measurement and IOL calculation to transform the day-to-day routine of busy practices and clinics. Heidelberg Engineering has leveraged its core OCT technolo
Florian Winterstein Becomes New CEO of Jedox21.9.2018 18:46 | Tiedote
The supervisory board of Jedox AG, a leading vendor of business intelligence and enterprise planning software, has appointed Florian Winterstein as Chief Executive Officer (CEO) effective October 2, 2018. This nomination will support Jedox’s international growth and a new development phase initiated by its latest fund raising in April 2018 with Iris Capital, eCAPITAL entrepreneurial Partners AG and Wecken & Cie. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005416/en/ Florian Winterstein (Photo: Business Wire) With 25 years of experience in strategy consulting and leadership in software and service organizations, Winterstein brings to the company a valuable combination of expertise in cloud solutions, business development, and value creation for customers and partners. As former Chief Strategy Officer of BravoSolution, he positioned the software-as-a-service company as trendsetting digitalization partner, extending it
Avinor to Test Autonomous Snowploughs at Oslo Airport This Winter21.9.2018 17:37 | Tiedote
Since 2010 Avinor has had a vision and a desire to automate winter maintenance. In March autonomous snow clearing was demonstrated at Fagernes Airport, and this winter Avinor is taking this a step further by testing two autonomous snowploughs at Oslo Airport. The project is one of the first globally where large machinery will operate autonomously to keep snow away from airport areas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005363/en/ Avinor to Test Autonomous Snowploughs at Oslo Airport This Winter (Photo: Business Wire) “Innovation is important to Avinor. In the future, many tasks in aviation will be resolved in other ways than today. Avinor wants to test autonomy, and does of course see a potential for rationalization in the future through new solutions for winter operations and in other areas. Avinor is at the forefront of testing this technology, but it is essential that safety is ensured in all such testing
Takeda Receives Positive CHMP Opinion Recommending ALUNBRIG® (brigatinib) for the Treatment of ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib21.9.2018 16:30 | Tiedote
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of ALUNBRIG® (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. ALUNBRIG is a tyrosine kinase inhibitor (TKI) designed to target and inhibit the ALK mutation in NSCLC. Approximately three to five percent of NSCLC patients globally have the ALK mutation. If the CHMP opinion is affirmed, and the European Commission approves ALUNBRIG, it will become the only ALK inhibitor available in the European Union as a one tablet per day dose that can be taken with or without food. The randomized, global Phase 2 ALTA trial was designed to investigate the efficacy and safety of ALUNBRIG in patients with locally advanced or metastatic ALK+
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme