Bausch + Lomb, Novaliq submit NDA for NOV03

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NOV03 is an investigational treatment with a proposed indication of treating the signs and symptoms of dry eye disease associated with Meibomian gland dysfunction.

Bausch + Lomb Corp. and Novaliq GmbH today announced the submission of a New Drug Application (NDA) at the end of June to the 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).

Joseph C. Papa, chairman and CEO of Bausch + Lomb, said the company is pleased by the prospects of advancing 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," Papa said in a news release. “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."

According to the companies, 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," Christian Roesky, PhD, CEO of Novaliq, said in the news release. "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."


NOV03 is an investigational, proprietary, water-free, single-component preservative-free eye drop.5 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 earlier this year in Washington, D.C

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. 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).

References

  1. Leonardi, A., Modugno, R. L., & Salami, E. (2021). Allergy and Dry Eye Disease. Ocular immunology and inflammation29(6), 1168–1176. https://doi.org/10.1080/09273948.2020.1841804.
  2. 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.
  3. 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.
  4. 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. Cornea31(5), 472–478. doi: 10.1097/ICO.0b013e318225415a.
  5. 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.
  6. 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.