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.

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.

Novaliq announces FDA acceptance of the new drug application for CyclaSol® for the treatment of dry eye disease

• PDUFA target action date is June 8, 2023

HEIDELBERG, Germany, and CAMBRIDGE, MA, USA, October 24, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CyclASol® (cyclosporine ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment for the signs and symptoms of dry eye disease (DED).

FDA accepts NDA filing for NOV03

VAUGHAN, Ontario, and HEIDELBERG, Germany, Sept. 6, 2022 – Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and 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 accepted the New Drug Application (NDA) filing for investigational treatment NOV03 (perfluorohexyloctane). A potential first-in-class eye drop with a novel mechanism of action, NOV03 is an investigational therapy to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). NOV03 has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

Dermaliq Therapeutics Announces First Patient Dosed in Phase 1b/2 Trial Evaluating DLQ02 for Treatment of Plaque Psoriasis

Wilmington, Delaware, August 18, 2022 – Dermaliq Therapeutics, Inc. (Dermaliq), a private, clinical stage pharmaceutical company with a focus on dermatology, today announced first patient dosed in a Phase 1b/2a trial with DLQ02, a topical calcineurin inhibitor. The trial is designed to evaluate the safety, systemic absorption, pharmacodynamics, and clinical efficacy of DLQ02 in patients with plaque psoriasis.

Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol®

Heidelberg, Germany, and Cambridge, MA, USA, August 09, 2022 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for CyclASol® (cyclosporine ophthalmic solution), a proposed novel treatment for the signs and symptoms of dry eye disease (DED).