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Novaliq Establishes U.S. Subsidiary in Cambridge, Massachusetts to Strengthen Its Presence in the Growing U.S. Eye Care Market

Heidelberg, Germany – January 8, 2018 – 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 formation of its new subsidiary, Novaliq Inc., which will be located in Cambridge, Massachusetts, U.S.

As an emerging leader in the field of ophthalmology, Novaliq is currently pursuing two late-stage clinical trials in the United States:

Novaliq’s ESSENCE phase 2b/3 clinical trial (NCT 03292809) is a pivotal randomized, double-masked, vehicle-controlled, multi-center trial, designed to evaluate the safety, efficacy and tolerability of topical CyclASol® for the treatment of dry eye disease (DED). CyclASol®, has demonstrated better efficacy and tolerability versus current gold-standard Restasis™ in a US Phase 2 trial.
Novaliq’s SEECASE clinical trial (NCT 03333057) is a phase 2, multi-center, randomized, double-masked, saline-controlled study to evaluate the effect of NOV03 at two different dosing regimens on the signs and symptoms of evaporative DED. NOV03 is potentially the first DED drug treatment addressing Meibomian gland dysfunction (MGD) and evaporative-caused DED.

The new Cambridge-based office will be headed by Novaliq’s founder and current chief innovation officer (CIO), Bernhard Günther. Mr. Günther will build the new U.S. organization to leverage the advantages and the potential of the water-free EyeSol® drug delivery technology and innovative products in the U.S. Novaliq Inc. is a 100% subsidiary of Novaliq GmbH.

“Over the past two years, Novaliq has gained significant momentum,” says Mr. Günther. “With the opening of our new U.S. subsidiary, we can better serve the important and growing U.S. eye care market. I am excited to take on this new challenge and to lead the internationalization of the Novaliq group.”

“As a leader in DED with first and best-in-class products, we see our role in redefining how this disease is treated,” says Christian Roesky, PhD, CEO of Novaliq GmbH. “In the U.S., more than 16 million patients are diagnosed with DED; however, only approximately 10 percent are being treated. This significant gap is a clear indication that new DED therapies are needed. A strong presence in the United States will assist us to better serve this vital pharma market.”

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.

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

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