VAUGHAN, ON and HEIDELBERG, Germany, July 7, 2022 /PRNewswire/ — 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 focused on first-in-class and best-in-class ocular therapeutics, today announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) in late June. from the United States to seek approval of NOV03 (perfluorohexyloctane), an investigational treatment with a proposed indication for the treatment of signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD) .
“We are excited to have the potential to advance the care of people with dry eye disease associated with meibomian gland dysfunction. If approved by the FDA, NOV03 will be the first available treatment indicated to treat the signs and symptoms in this patient population,” said Joseph C. Papa, Chairman and CEO of Bausch + Lomb. “The NOV03 case is an example of Bausch + Lomb’s commitment to bringing new treatment options to the industry so that we can better serve patients.”
DED is one of the most common ocular surface disorders, with approximately 18 million Americans diagnosed with DED.1.2 MGD is a major cause of the development and progression of evaporative DED, which is caused by a deficient lipid layer in the tear film that leads to increased tear evaporation.3 In one study, it was found that approximately 86% of DED patients had MGD involvement.4
“We are working hand-in-hand with Bausch + Lomb to bring this new treatment option, if approved, to the optometric and ophthalmic community so they can help meet the needs of patients with dry eye disease associated with dysfunction. of the meibomian gland,” said Christian Rosky, Ph.D., CEO, Novaliq. “This New Drug Application Submission is a critical milestone and the first drug submission for a waterless therapy. We are excited to unleash the full potential of NOV03 by providing this new drug option for this condition at United States.”
About NOV03 (Perfluorohexyloctane) Ophthalmic Solution
NOV03 is an experimental, exclusive, water-free and preservative-free eye drop.5 In 2019, Bausch + Lomb acquired an exclusive license for the commercialization and development of NOV03 in the United States and Canada. Data from the first pivotal Phase 3 (GOBI) trial evaluating NOV03 (perfluorohexyloctane) was presented at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting in washington d.c. on April 24, 2022. Data from the second pivotal Phase 3 trial (MOJAVE) was presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in denver on May 2, 2022. The results of the pivotal phase 2 trial (SEECASE) have been published in Cornea in September 2021.6 The clinical program for NOV03 has concluded with the completion of a 12-month, single-arm, open-label, multicenter safety extension trial (KALAHARI).
Novaliq is a biopharmaceutical company focused on the development and commercialization of premium ocular therapeutic products based on EyeSol®, the world’s first waterless technology. Novaliq offers an industry-leading portfolio that addresses the current unmet medical needs of millions of eye disease patients. 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 sciences and healthcare companies. More information at www.novaliq.com.
About Bausch + Lomb
Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every stage of life. Its comprehensive portfolio of over 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products, and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and sales footprint with more than 12,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, ON with headquarters in Bridgewater, New Jersey. For more information, visit www.bausch.com and contact us at TwitterLinkedIn, Facebook and Instagram.
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Leonardi, A., Modugno, RL and Salami, E. (2021). Allergy and dry eye. Ocular immunology and inflammation, 29(6), 1168-1176. https://doi.org/10.1080/09273948.2020.1841804.
Dry Eye Products Market Report 2020: A Global Analysis from 2019 to 2025. Market Scope. Retrieved from https://www.market-scope.com/pages/reports/250/2020-ophthalmic-landscape-report-global-analysis-for-2019-to-2025-april-2021#reports.
Geerling, Gerd et al. “Emerging Strategies for the Diagnosis and Treatment of Meibomian Gland Dysfunction: Proceedings of the OCEAN Group Meeting.” The ocular surface flight. 15.2 (2017): 179-192. doi:10.1016/j.jtos.2017.01.006.
Lemp, MA, Crews, LA, Bron, AJ, Foulks, GN and Sullivan, BD (2012). Distribution of water-deficient and evaporative dry eye disease in a cohort of clinical patients: a retrospective study. Cornea, 31(5), 472–478. doi: 10.1097/ICO.0b013e318225415a.
In December 2019Bausch Health has acquired the rights from Novaliq GmbH to continue the development and commercialization of NOV03 for DED and combination products based on NOV03 in additional ophthalmic indications in United States and Canada.
Tauber J, Wirta DL, Sall K, Majmudar PA, Willen D, Krösser S; SEECASE study group. A randomized clinical study (SEECASE) to evaluate the efficacy, safety and tolerability of NOV03 for the treatment of dry eye disease. Cornea. 2021; 40(9):1132-1140.
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