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.
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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.
Bausch + Lomb and Novaliq Announce Publication of Second Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in American Journal of Ophthalmology NOV03 Consistently Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction NOV03 PDUFA Action Date is June 28, 2023VAUGHAN, Ontario, and HEIDELBERG, Germany, March 22, 2023 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, today announced that American Journal of Ophthalmology has published results from MOJAVE, the second pivotal Phase 3 trial for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Results from the first pivotal Phase 3 trial, GOBI, were published earlier this year in Ophthalmology. The U.S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.
Heidelberg, Germany, and Cambridge, MA, USA, Feb 8, 2023 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced its plans for filing a Marketing Authorisation Application (MAA) for CyclASol® (ciclosporin ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment of dry eye disease (DED) in the European Union.