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 the submission of a New Drug Application (NDA) at the end of June to the U.S. Food and Drug Administration (FDA) seeking approval for NOV03 (perfluorohexyloctane), an investigational treatment with a proposed indication of treating the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).
“We are thrilled to have the potential to advance the care of people suffering from dry eye disease associated with Meibomian gland dysfunction. If approved by the FDA, NOV03 will be the first available therapy indicated to address the signs and symptoms for this patient population,” said Joseph C. Papa, chairman and CEO, Bausch + Lomb. “The NOV03 filing is an example of the commitment of Bausch + Lomb toward bringing novel 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 tear film lipid layer that leads to increased tear evaporation.3 In one study, it was found that approximately 86% of patients with DED had MGD involvement.4
“We are working hand-in-hand with Bausch + Lomb to bring this novel treatment option, if approved, to the optometric and ophthalmic community so they can help address the needs of patients with dry eye disease associated with Meibomian gland dysfunction,” said Christian Roesky, Ph.D., CEO, Novaliq. “This New Drug Application submission is a critical milestone and the first drug submission of a water-free therapy. We are excited to unfold the full potential of NOV03 by bringing this novel drug option for this condition to the United States.”
About NOV03 (perfluorohexyloctane) Ophthalmic Solution
NOV03 is an investigational, proprietary, water-free, single-component 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 trial (GOBI) evaluating NOV03 (perfluorohexyloctane) were 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) were presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Denver on May 2, 2022. Results from the pivotal Phase 2 trial (SEECASE) were published in Cornea in September 2021.6 The clinical program for NOV03 concluded with the completion of a multi-center, open-label, single-arm, 12-month safety extension trial (KALAHARI).
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.
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 phase of life. Its comprehensive portfolio of more than 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 commercial footprint with more than 12,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visit www.bausch.com and connect with us on Twitter, LinkedIn, Facebook
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