Skip to main content

Novaliq named Finalist in “Clinical Trial Result of the Year” category of the LifeStars Awards 2019

Heidelberg, Germany – September 10, 2019 – Novaliq is pleased to announce that it has been recognised in the finalist roster of the Clinical Trial of the Year at the 2019 Lifestars AwardsTM.

Lifestars is a celebration of the success stories, innovations, transformational deals and the people, teams and organisations that play such a critical role in the advancement of the industry over the last 12 months across Europe and the US.

In 2018, Novaliq conducted SEECASE-1, a phase 2, multi-center, randomized, double-masked, comparator-controlled clinical trial (NCT03333057) which was designed to evaluate the effects of NOV03 at two different dosing regimens on signs and symptoms of DED.

NOV03 (100% perfluorohexyloctane) stabilizes the lipid layer of the tear film for hours, thereby preventing excessive tear evaporation. Furthermore, NOV03 uniquely penetrates Meibomian glands and potentially dissolve thickened Meibum, thereby improving Meibomian gland function and quality. Patients enrolled were suffering from DED due to significant MGD presence – a very symptomatic and highly underserved population.

In SEECASE-1, NOV03 showed unprecedented sign and symptom improvements for DED patients while offering an excellent safety and tolerability profile; the new mode of action of NOV03 addresses the underlying causes of evaporative DED associated with MGD, thereby treating signs and symptoms of the diseases in a highly effective way.

The international awards brings together hundreds of global life science leaders, investors and deal makers and key stakeholders from the wider eco-system to recognise the achievements of the industry. 17 awards will be contested during a prestigious gala dinner hosted at the Honourable Artillery Company in London, UK on the 19thNovember. The Awards will support Teenage Cancer Trust as the official Charity beneficiary.

“We are pleased being nominated by LSX for a Lifestars Award for our NOV03 Clinical trial showing significant benefits for patients with dry eye disease which is associated with meibomian gland dysfunction.” Sonja Krösser, PhD, VP Preclinical and Clinical Development, Novaliq GmbH.

“Lifestars presents a fantastic opportunity to bring together a deserved audience and highlight the advances being made in our industry. It’s testament to Novaliq efforts that this year’s judging faculty have recognised them in this manner.” Neil Darkes, Co-CEO, LSX Ltd. and LifestarsTM

 

About LifestarsTM

The LifestarsTM Awards are organised by LSX, an influential community of senior life science decision makers. Through impactful events, powerful thought leadership content and unique networking opportunities, LSX exists to forge a fundamentally better way to promote and facilitate investment, financing, partnerships and deal making in healthcare. For more information please visit www.lsxleaders.com/lifestars-awards

About Novaliq

Novaliq is a pharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free eye drop technology. Novaliq offers an industry-leading portfolio addressing the needs of patients with eye diseases: NOV03 is the first investigational drug in phase 3 to treat evaporative DED associated with Meibomian gland dysfunction in a highly effective way. CyclASol®, 0.1% cyclosporine A in EyeSol®, is an anti-inflammatory and immunomodulating drug developed for the treatment of aqueous deficient DED. NovaTears® water-free eye drops for dry eye have CE certification and are commercialized in Australia/New Zealand by AFT Pharmaceuticals and in Europe as EvoTears® by Ursapharm. Headquartered in Heidelberg/Germany, Novaliq has an office in Cambridge, MA/USA. Long-term shareholder is dievini Hopp BioTech.

Novaliq and Laboratoires Théa Announce Partnership and EU Approval for Vevizye (Ciclosporin 0.1% Eye Drops Solution)

Heidelberg, Germany, Cambridge, MA, USA, and CLERMONT-FERRAND, France, October 2, 2024 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, and Laboratoires Théa (Théa), the leading independent eye care group in Europe, announce European Commission approval of Vevizye® (ciclosporin 0.1% eye drops solution) in Europe and the closing of a partnership under which Théa has acquired the rights to commercialise the product in Europe and selected countries in the Middle East and North Africa (MENA).
Read more

Novaliq Receives Positive CHMP Opinion FOR Vevizye® in Dry EYE Disease

Heidelberg, Germany, and Cambridge, MA, USA, July 29, 2024 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, announces that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorisation in the European Union for Vevizye®, intended for the treatment of moderate to severe dry eye disease in adult patients, which has not improved despite treatment with tear substitutes.

Read more

European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol® (Ciclosporin eye drops, solution 1 mg/mL) for the Treatment of Dry Eye Disease

Heidelberg, Germany, and Cambridge, MA, USA, August 24, 2023 – Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new drug treatment for dry eye disease in patients not responding to tear substitutes. The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized procedure for all 27 member states of the European Union (EU).
Read more

Harrow Acquires U.S. and Canadian Commercial Rights to VEVYE® (Cyclosporine Ophthalmic Solution) 0.1% from Novaliq

VEVYE® is the First and Only Cyclosporine-Based Product Indicated for the Treatment of Both Signs and Symptoms of Dry Eye Disease with Efficacy Demonstrated After Four Weeks VEVYE® is the Only Water-Free Ophthalmic Product with Convenient Twice-Daily (BID) Dosing NASHVILLE, Tenn. & HEIDELBERG, Germany, July 18, 2023 – Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, and Novaliq GmbH, a German biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced an agreement under which Harrow will acquire the U.S. and Canadian commercial rights for VEVYE® (cyclosporine ophthalmic solution) 0.1%, a patented, non-preserved, ophthalmic solution prescription drug based on Novaliq’s proprietary EyeSol® water-free technology. VEVYE, which is dispensed topically in a unique 10 microliter per one drop and is labeled for twicedaily (BID) dosing, is the first and only cyclosporine-based product indicated for the treatment of both signs and symptoms of dry eye disease (DED). VEVYE was approved on May 30, 2023, by the U.S. Food and Drug Administration (FDA).
Read more

Senju Pharmaceutical and Novaliq Enter Into License Agreement For NOV03 (Perfluorohexyloctane Ophthalmic Solution) For the Treatment of Dry Eye Disease in Japan

Senju Pharmaceutical and Novaliq Enter Into License Agreement For NOV03 (Perfluorohexyloctane Ophthalmic Solution) For the Treatment of Dry Eye Disease in Japan Osaka, Japan & Heidelberg, Germany, and Cambridge, MA, USA, June 13, 2023 – 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.
Read more