Heidelberg, Germany, October 12, 2021 – Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced that it has implemented and applies a quality management system in accordance with Annex IX, Chapter I of the EU Medical Device Regulation (MDR), for conformity assessment of its medical devices NovaTears®, NovaTears®+Omega-3 and EvoTears™ OMEGA.
Medical devices are products or equipment intended generally for a medical use. On 26 May, 2021, the Medical Device Directive (MDD) has been replaced by the new Medical Device Regulation (MDR). MDR is designed to be an improved version of MDD, increasing in particular the standards on quality and safety measures.
Medical devices in the EU have to undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment.
The changes introduced in the MDR affect a variety of aspects in the CE marking process. Some of these processes include device classification, technical file documentation, new responsibilities for the European Medicines Agency (EMA) and post-market activities. The goal of this is to increase the qualitative standards of medical devices within the EU, ensuring improved levels of safety whilst encouraging innovation.
An audit by mdc medical device certification GmbH has proven that Novaliq’s quality management system fullfils the respective requirements and a conformity certificate has been issued in September 2021.
“We are very pleased with our decision to implement MDR already in 2021. The safety and quality of our products is a priority to us. Therefore we always seek to implement the highest standards for the benefit of patients, customers and partners ,” said Christian Roesky, Ph.D., Managing Director and CEO, Novaliq.
About Novaliq’s medical device eye care products
NovaTears® is the first water-free and preservation-free eye drop for the treatment of dry eye. The product is CE certified since 2014 and successfully commercialized in Australia/New Zealand by AFT Pharmaceuticals and in Europe as EvoTears™ by Ursapharm. As the first-of-its kind, NovaTears® offers a new mode of action by acting as a lubricating lipid layer stabilizer and evaporative barrier for improving tear film stability and quality. NovaTears® is clinically validated by demonstrating improvement in signs and symptoms in evaporative dry eye disease (DED) and dry eye associated with meibomian gland dysfunction (MGD) patients.1;2 With millions of NovaTears®/EvoTears™ units sold, the technology is proven to be safe and well accepted.
NovaTears®+Omega-3 is the first vegan eye drop formulation combining perfluorohexyloctane, the sole ingredient of NovaTears®, with omega-3 fatty acid esters which are a natural component of the tear film and potentially important for evaporation and oxidative stress resistance. The product is free of antimicrobial preservatives and does not contain phosphate. NovaTears®+Omega-3 eye drops provide an easy and unique way to supply omega-3 right to the place of application for patients concerned about their eyes. The product received CE-marking in October 2017 and is commercialized in Australia/New Zealand by AFT Pharmaceuticals and in Europe as EvoTears™ OMEGA by Ursapharm.
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. Novaliq offers an industry-leading portfolio addressing today’s unmet medical needs of millions of patients with eye diseases. 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.