Bausch + Lomb and Novaliq Announce Submission of New Drug Application for Investigational Treatment NOV03 (Perfluorohexyloctane)
Bausch + Lomb and Novaliq announced on July 7, 2022, the submission of a New Drug Application (NDA) for NOV03 (perfluorohexyloctane) to the FDA. This investigational treatment aims to address dry eye disease (DED) associated with Meibomian gland dysfunction (MGD), which affects approximately 18 million Americans. If approved, NOV03 would be the first therapy indicated for this condition. The NDA submission marks a significant milestone in Bausch + Lomb's commitment to developing innovative eye care solutions.
- Submission of NDA for NOV03 could fulfill a significant unmet medical need in treating dry eye disease.
- If approved, NOV03 would be the first therapy specifically aimed at DED associated with MGD.
- FDA approval is uncertain, and delays could impact the expected market entry for NOV03.
- Potential risks associated with the clinical trial outcomes and market acceptance.
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 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
"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).
About Novaliq
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 and Instagram.
Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb's filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch + Lomb, including but not limited to its project development timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
References
- Leonardi, A., Modugno, R. L., & Salami, E. (2021). Allergy and Dry Eye Disease. Ocular immunology and inflammation, 29(6), 1168–1176. https://doi.org/10.1080/09273948.2020.1841804.
- 2020 Dry Eye Products Market Report: A global Analysis for 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 vol. 15,2 (2017): 179-192. doi:10.1016/j.jtos.2017.01.006.
- Lemp, M. A., Crews, L. A., Bron, A. J., Foulks, G. N., & Sullivan, B. D. (2012). Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea, 31(5), 472–478. doi: 10.1097/ICO.0b013e318225415a.
- In December 2019, Bausch Health acquired the rights from Novaliq GmbH to pursue development and commercialization of NOV03 for DED and combination products based on NOV03 in additional ophthalmic indications in the 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 Assess Efficacy, Safety, and Tolerability of NOV03 for Treatment of Dry Eye Disease. Cornea. 2021; 40(9):1132-1140.
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