Business Wire

Novaliq’s NovaTears®+Omega-3 Approved in Europe for the Enhanced Treatment of Evaporative Dry Eye Disease

Del

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.

Source:

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.

# # #

Contact information

Novaliq GmbH
For US:
Michael O’Rourke, + 1-813-323-1438
Strategic Consultant
mrourke@novaliq.com
or
For EU/Asia:
Heidrun Kirsch, + 49 6221 50259 243
VP Marketing
hkirsch@novaliq.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

IWBI Launches Global Network of Advisors for WELL Portfolio16.10.2018 18:00Pressemelding

The International WELL Building Institute™ (IWBI™) today announced the formation of a global advisory to help shape and advance the implementation of the WELL Portfolio™ Pathway pilot, a new streamlined pathway for WELL Certification™ for multiple new or existing buildings and tenant spaces in a single portfolio. WELL Portfolio, announced this past month, is being released as part of the WELL v2™ pilot, the latest iteration of the WELL Building Standard™ (WELL™). It is part of a suite of enhancements to WELL that addresses growing demand across the building industry for a program that helps owners, developers and tenants streamline and scale health and wellness upgrades to their real estate assets. The advisory includes a collection of professionals, practitioners and experts across a range of industries and sectors, each serving a one-year term. “Since we launched WELL, we’ve seen an explosion of interest from global companies to bring the same health and wellness benefits across thei

The X7 Delivers Right-sized Packaging Automation from Packsize While Reducing Labor, Shipping, and Material Costs16.10.2018 17:55Pressemelding

The continued decline in unemployment is impacting companies across nearly every industry; a reported 3.7 percent national average in September by the U.S. Department of Labor. Heightened demand for goods ordered over the internet amplifies the worker shortage for these companies shipping products. To ensure optimal and timely outcomes and smart industry improvements for its customers, Packsize today announces its fully automated, right-sized packaging system, the X7™. The new automated custom box-making system represents a significant investment by Packsize in machine learning, packaging process automation, corrugated infrastructure and testing, and business intelligence. The automated system is the second in the company’s X Series line of automated, On Demand Packaging® technology solutions. Advancing packaging automation for complex, single- and multiple-item orders, the X7™ achieves sustainability and supply chain workflow optimization. Delivering the most needed functions to make,

Event Software Company Aventri Acquires ITN International16.10.2018 16:00Pressemelding

Leading event management software company Aventri announced the acquisition of ITN International, the industry leader in NFC, mobile and cloud-based technology. With the acquisition of ITN, Aventri will broaden its technology and service offerings, expanding its global reach and the events that they support. Servicing annually 125 events, 10,000 exhibitors and 1.5 million attendees, ITN serves event producers by combining technology with personalized professional services to optimize events. A look at their product set includes: Online registration system with speaker management, agenda builder, session scheduling, and more. Onsite services include NFC badges, check-in stations, lead retrieval, apps, RFID scanning and more. Data visualization tools with advanced reporting and analytics around registration, badge activity and scans. “The acquisition of ITN as a global provider of cloud-based event management solutions is a major growth opportunity for Aventri,” says Oni Chukwu, CEO of A

Thales and Gemalto Are Granted Regulatory Clearance from the Competition Commission in South Africa16.10.2018 16:00Pressemelding

Regulatory News: Reference is made to the joint press release by Thales (Euronext Paris: HO) and Gemalto (Euronext Amsterdam and Paris: GTO) dated 27 March 2018 in relation to the launch of the recommended all-cash offer by Thales for all the issued and outstanding shares of Gemalto (the “Offer”), the publication of the Offer Document, and the joint press release of Thales and Gemalto dated 10 August 2018 in relation to the further extension of the Acceptance Period. Terms not defined in this press release will have the meaning as set forth in the Offer Document. Thales and Gemalto today announce that they have received Regulatory Clearance from the Competition Commission in South Africa. Together with the antitrust clearances obtained in China, Israel and Turkey, and clearances relating to foreign investments in Australia, Canada and the USA (CFIUS), Thales and Gemalto have now obtained 7 of the required 14 Regulatory Clearances. Thales and Gemalto continue to work constructively with

Piraeus Bank Finances the Development of Thriassio Transit Center16.10.2018 15:39Pressemelding

Piraeus Bank will finance the development of the Thriassio Transit Center, which will help increase freight transport by rail and promote Greece as a major freight hub in the trans-European transport network. The Center will significantly increase freight transport by rail and promote Greece as a major freight hub in the trans-European transport network. It will contribute to the provision of upgraded services while also reducing transport costs, which are key factors in lowering the final price of products, having a direct positive impact on the competitiveness of the economy and GDP growth. The project is also expected to boost local employment, creating up to 5,000 jobs over the next 10 years. The new Thriasio Transit Center is expected to become operational in 2024. Piraeus Bank Chief Executive Officer, Mr. Christos Megalou said: “Piraeus Bank are always looking for suitable investment projects that align with our strategy to be a pillar of stability for the Greek economy and we ar

Inside Secure’s Latest Whitebox Software Security Tool Brings Mobile Developers New Levels of Protection, Performance and Control16.10.2018 15:36Pressemelding

Regulatory News: Inside Secure (Paris:INSD), at the heart of security solutions for mobile and connected devices, today announced general availability of its Whitebox 3.0 software crypto-security tool that protects cryptographic keys and algorithms inside mobile applications that demand top-notch security. Inherently running in an exposed environment, mobile applications are susceptible to attackers who can then see all the secrets within the app. As a proven innovator in software security, Inside Secure builds on numerous years of successful integrations for top developers to offer the best technology for hiding data and cryptography on mobile devices. Serving as an appealing alternative to an expensive, hardware-dependent Trusted Execution Environment (TEE) or Secure Element (SE) Whitebox 3.0 secures assets with uniquely powerful features that bring industry-changing gains in performance and flexibility – key traits that developers demand. Inside Secure’s pure software approach means