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

HEIDELBERG, Germany--(BUSINESS WIRE)-- 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.

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