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Sonja Kroesser named Top 25 Women Leaders in Biotechnology of 2022

Heidelberg, Germany, and Cambridge, MA, USA, November 15, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, is proud to announce that today our own Sonja Kroesser, Vice President and Head of Preclinical and Clinical Development, was named as a Top 25 Women Leaders in Biotechnology of 2022 by the Healthcare Technology Report.

“The accomplished women selected for this year’s awards represent a diverse range of leadership positions, specialties, and backgrounds, from entrepreneurs building new companies, to scientists discovering innovative ways to treat deadly diseases, to executives enabling their companies to navigate an increasingly competitive industry”, says the publication.1 “The exceptional women on this year’s list were selected based on our comprehensive analysis of hundreds of nominations, taking into consideration professional milestones achieved, demonstrated domain expertise, and longevity in the biotech field. Feedback from colleagues, industry influence, and previous honors and recognition received were also assessed, along with numerous other metrics, to arrive at our final list.”

Dr. Krösser is the Vice President and Head of Preclinical and Clinical Development at Novaliq GmbH. In 2022, the U.S. Food and Drug Administration (FDA) accepted two New Drug Applications (NDA) submitted within three months for two first-of-its-kind dry eye disease therapies based on EyeSol®. Both NDAs are based on comprehensive clinical programs that have been designed, planned, and interpreted under Dr. Krösser’s supervision. The two distinct modalities of action of the EyeSol®-based dry eye therapies open new clinical prospects on how to treat this serious disease in the future. If approved by the FDA, important unmet medical needs for approximately 18 million Americans diagnosed with dry eye disease will be addressed.

As a registered pharmacist, Dr. Krösser has dedicated her career to clinical pharmacology and clinical development, starting her career at Merck, a global pharmaceutical company. She received her degree in microbiology at the University of Heidelberg. With profound ophthalmic, clinical, and regulatory experience, Dr. Krösser has demonstrated outstanding achievements in cross-functional leadership and management of global teams with partners around the globe. She is the author of multiple peer-reviewed scientific publications, papers, and posters. With over 20 years of industry experience, Dr. Krösser has changed the paradigm of topical therapies based on water-free eye drops to better treat patients and their vision.”

Please join us in celebrating Dr. Kroesser and The Top 25 Women Leaders in Biotechnology of 2022.

About The Heathcare Technology Report

The Healthcare Technology Report is your comprehensive source for business news, investment activity and corporate actions related to the healthcare technology industry.

About Novaliq

Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology. EyeSol® is Novaliq’s proprietary water-free technology using ultrapure semifluorinated alkanes (SFAs) that are physically, chemically, and physiologically inert with excellent biocompatibility and a very good safety profile. Novaliq offers an industry-leading portfolio addressing today’s unmet medical needs of millions of patients with eye diseases.

In September 2022 acceptance of filing of a New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) was announced for NOV03 (perfluorohexyloctane), for the proposed indication of treating the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). PDUFA target action date for NOV03 is June 28, 2023. In addition to CyclASol®, the company continues to progress multiple additional pipeline opportunities based on its validated EyeSol® platform, both in ophthalmology and adjacent indications like dermatology.

Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More on www.novaliq.com.

Recommended Readings 

  1. https://thehealthcaretechnologyreport.com/the-top-25-women-leaders-in-biotechnology-of-2022/

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).

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.

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.