PDUFA Action Date is June 28, 2023
VAUGHAN, Ontario and HEIDELBERG , Germany , Sept. 6, 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, plus Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the Oughout. S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for investigational treatment NOV03 (perfluorohexyloctane). A potential first-in-class eye drop with a novel mechanism of action, NOV03 is an investigational therapy to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). NOV03 has been assigned the Prescription Medication User Fee Act (PDUFA) action date of 06 28, 2023 .
“With the FOOD AND DRUG ADMINISTRATION commencing review of the NDA filing, we are one step closer in order to bringing an important new treatment option to the millions of Americans affected by dry vision disease related to Meibomian glandular dysfunction, ” said Joseph C. Papa , CEO, Bausch + Lomb. “NOV03 is distinct from anti-inflammatory and immunomodulatory agents, plus, if approved, would be the first prescription attention drop to address excessive tear evaporation. The approval would also mark a significant milestone for Bausch + Lomb, as the company’s first FDA approval for a prescription medicine since becoming a publicly traded organization earlier this year. inch
DED will be one of the most common ocular surface disorders, with MGD as a major cause of development and progression, affecting approximately nine out associated with 10 individuals with DED. 1, 2 DED due to MGD is usually caused by a deficient tear film lipid layer that leads in order to increased rip evaporation. 3 There is currently no authorized prescription eyesight drop in the United States with regard to DED connected with MGD.
“We are thrilled the FOOD AND DRUG ADMINISTRATION has approved our NDA filing regarding NOV03, ” said Christian Roesky , Ph. D., CEO, Novaliq. “With only limited treatment options currently available, NOV03 is definitely a promising potential brand new therapy, specifically designed to alleviate the signs and symptoms of dried out eye illness associated with Meibomian gland dysfunction. ”
The particular clinical development program intended for NOV03 includes two Phase 3 studies (GOBI plus MOJAVE), both of which demonstrated statistically significant improvement vs. control to get both primary and key secondary sign and symptom endpoints because early since day 15 and through day 57. NOV03 was well tolerated in both research.
About NOV03 (perfluorohexyloctane) Ophthalmic Solution
NOV03 (perfluorohexyloctane) is an investigational, proprietary, water-free, non-steroidal, single-component preservative-free eyes drop. 4 In 2019, Bausch + Lomb acquired a good exclusive license for the commercialization and development of NOV03 in the particular United States and Canada. Data from the 1st pivotal Stage 3 trial (GOBI) were presented at the American Society of Cataract plus Refractive Surgery (ASCRS) annual meeting within Washington, Deb. C. on April 24, 2022 . Data from your second pivotal Phase 3 trial (MOJAVE) were presented at the Association pertaining to Research in Vision and Ophthalmology (ARVO) annual meeting in Denver on May 2, 2022 . Results from the particular pivotal Phase 2 test (SEECASE) had been published within Cornea in September 2021 . 5 The clinical program for NOV03 concluded with the completion associated with a multi-center, open-label, single-arm, 12-month safety extension demo (KALAHARI).
Novaliq can be a biopharmaceutical company concentrating on the advancement and commercialization of first- and best-in-class ocular therapeutics based upon 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 certainly headquartered in Heidelberg, Germany plus Novaliq Inc. has an office in Cambridge, MA, USA. The particular long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, a good 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 hundreds of thousands of people around the world – from the moment of birth via every phase of life. Its comprehensive portfolio associated with more than 400 products includes contact lenses, lens care items, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices plus instruments. Founded in 1853, Bausch + Lomb has a substantial global research and development, manufacturing and commercial footprint with more than 12, 000 employees and a presence within nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario along with corporate offices in Bridgewater, New Jersey . For more information, visit www.bausch.com and connect with us on Twitter , LinkedIn , Facebook and Instagram .
This news release may contain forward-looking statements, which may generally become identified by the use of the words “anticipates, inch “hopes, ” “expects, inch “intends, ” “plans, inch “should, ” “could, inch “would, ” “may, inch “believes, ” “estimates, inch “potential, ” “target, inch 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 plus uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These types of risks and uncertainties include, but are not limited in order to, the risks plus uncertainties discussed in Bausch + Lomb’s filings with the U. S. Securities and Exchange Commission and the Canadian Investments Administrators, which factors are usually incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused simply by or relating to the evolving COVID-19 pandemic, as well as the fear of that pandemic and its potential effects, the particular severity, duration and future impact associated with which are highly uncertain and cannot be predicted, and which might have a material adverse impact on Bausch + Lomb, including but not limited to its project development timelines, launches plus costs (which may increase). Readers are usually cautioned not to place undue reliance on any of these forward-looking claims. These forward-looking statements speak only as of the day hereof. Bausch + Lomb undertakes no obligation in order to update some of these forward-looking statements to reflect events or circumstances after the date of this news release or to reveal actual outcomes, unless required by law.
- Leonardi, The., 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 .
- Lemp, M. A., Crews, L. A., Bron, The. J., Foulks, G. N., & Sullivan, B. M. (2012). Distribution of aqueous-deficient and evaporative dry vision in a clinic-based patient cohort: a retrospective study. Cornea , 31(5), 472–478. https://doi.org/10.1097/ICO.0b013e318225415a
- Geerling G, Baudouin C, Aragona P, et al. (2017). Emerging strategies for the diagnosis and treatment of meibomian gland disorder: Proceedings of the OCEAN group conference. The Ocular Surface, 15(2): 179-192. https://doi.org/10.1016/j.jtos.2017.01.006
- Within December 2019 , Bausch + Lomb acquired the particular rights from Novaliq GmbH to pursue development plus commercialization associated with NOV03 meant for DED and combination products based on NOV03 within additional ophthalmic indications in the United States plus Canada .
- Tauber J, Wirta DL, Sall K, Majmudar PA, Willen G, Krösser S; SEECASE study group. (2021). A randomized clinical research (SEECASE) to assess efficacy, safety, and tolerability of NOV03 designed for remedying of dry eye condition. Cornea; 40(9): 1132-1140. http://doi.org/10.1097/ICO.0000000000002622 .
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