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Novaliq to present at the Ophthalmology Futures Forum on how to break the vicious circle of Dry Eye Disease

Heidelberg, Germany – Sep 19, 2018 – Novaliq will present at the upcoming Ophthalmology Futures Forums in Vienna.
The Ophthalmology Futures Forums were established in 2012 to fill a void with regard to industry – investor meetings specifically for ophthalmology in Europe and Asia. The Forums focus on all aspects of global innovation in ophthalmology by connecting scientists, physicians, regulators, corporate leaders, venture capitalists and other investors who support the advancement of eye care.

In Europe, Dry Eye Disease (DED) has a prevalence of 8-17%. In the top five European countries (France, Germany, Italy, Spain, UK) more than 25 million people have symptoms of dry eyes and 18 million have been diagnosed with DED – yet only 3 million patients have been treated(1).
Current treatment options for patients in Europe are limited; so far only one drug was approved by the European Medicines Agency (EMA) for the treatment of severe keratitis in adults with DED. First choice in Europe remain artificial tears and eye lubricants. Outside Europe only few products are approved for the treatment of DED in US or Japan.
Dry eye has an effect on the quality of life and affects people from all walks of life. At a minimum, dry eye causes discomfort, but it can also cause disabling pain and vision disturbance. Recent publications highlight the correlation of dry eye and reading impairment (2,3). New advances for this disease and genuine treatment options are clearly needed to break the vicious circle of Dry Eye Disease.

With a portfolio of best- and first-in-class products and two global clinical programs for CyclASol® and NOV03, Novaliq takes on the challenge to break the vicious circle of Dry Eye Disease. Results of the global clinical programs are expected to be communicated in October.

Dry Eye Disease causes more than discomfort, since visual function can be impacted as well. Current treatment options for Dry Eye Disease leave too many patients untreated and unsatisfied,” said Christian Roesky, CEO of Novaliq GmbH. “With our drugs in late-stage clinical development, we will redefine how DED is treated.
Christian Roesky will speak at the Ophthalmology Futures Forums, September 20th, 2018 in Vienna, Austria. For further information, please send an email to event@novaliq.com.

 


Sources
1) Dry Eye Syndrome: Global Drug Forecast and Market Analysis to 2026, Published June 2018 by Global Data
2) Karakus S et al; Ophthalmology 2018, 125: 1500-1505
3) Koh S; Cornea 2016, 35: S83-S88

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).

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).

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.

Novaliq Announces FDA Approval of VEVYE (Cyclosporine Ophthalmic Solution) 0.1%, for the Treatment of the Signs and Symptoms of Dry Eye Disease

Novaliq Announces FDA Approval of VEVYE (Cyclosporine Ophthalmic Solution) 0.1% for the Treatment of the Signs and Symptoms of Dry Eye Disease VEVYE is the first and only cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks Heidelberg, Germany and Cambridge, MA, USA, June 8, 2023 – Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has approved VEVYE (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease. VEVYE (development name CyclASol®) is the first and only cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment.

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