VAUGHAN, Ontario & HEIDELBERG, Germany–( )–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 that Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, has published results from the particular pivotal Phase 3 trial GOBI, which is one associated with two pivotal Phase 3 trials for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). The U. S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

NOV03 was specifically developed to address excess tear evaporation plus alleviate the signs or symptoms of dry vision disease associated with Meibomian gland dysfunction, ” said Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb. “ These findings reinforce NOV03 as the potential new treatment option that is distinct from anti-inflammatory and immunomodulatory agents. We are excited that the particular FDA is reviewing the New Drug Application with regard to NOV03, which, if approved, would provide millions of patients with dried out eye illness related to Meibomian gland disorder a prescription treatment choice. ” 1

DED is usually one associated with the most common ocular surface disorders, with MGD as a major cause of development and progression, affecting approximately nine out of 10 people with DED. 2, 3 DED due to MGD is caused by a deficient tear film lipid layer that leads in order to increased rip evaporation. 4 There is currently no authorized prescription attention drop in the United States indicated regarding DED connected with MGD.

These data show that the particular GOBI test met both co-primary endpoints and all key secondary endpoints, with statistical significance achieved in treating the signs associated with dry eyesight disease connected with Meibomian gland malfunction as early as day 15, ” said Christian Roesky, Ph. D., CEO, Novaliq. “ We are pleased to be able to share these exciting findings in Ophthalmology, plus we look forward to our continued collaboration along with Bausch + Lomb in order to hopefully bring NOV03 to market in the particular United States, and ultimately address an unmet medical need for those suffering with dry eye condition associated with Meibomian gland problems. ”

All of the individuals in the study were required to meet specific criteria indicating presence of Meibomian gland dysfunction. The results of this study reinforce NOV03 as a potential treatment option for this patient population with unmet healthcare needs, ” said Yehia Hashad, M. D., executive vice president, Research & Development and chief medical officer, Bausch + Lomb.

The data from the Stage 3, multicenter, randomized, hypotonic saline-controlled, double masked GOBI study was based on outcomes from 597 subjects aged 18 years and older who were randomized to either receive treatment along with NOV03 four times daily or hypotonic saline solution four times daily (n=303 NOV03; n=294 saline).

The two primary endpoints had been change from baseline at Week 8 (Day 57 ± 2) in total corneal fluorescein staining (tCFS) plus eye dryness Visual Analog Scale (VAS) score. Key secondary endpoints included change from baseline in eyes dryness VAS score and tCFS in Week two (Day 15 ± 1) and eye burning/stinging VAS score plus central corneal fluorescein discoloration (cCFS) from Week eight. Significant improvements vs. hypotonic saline solution were seen as early because day fifteen. Data highlights include:

Primary endpoints

  • At Week 8, change from baseline in tCFS has been statistically significantly greater in the NOV03 arm compared to the control saline group (least-squares [LS] mean treatment difference, -0. 97; (95% confidence interval [CI]: -1. 40 vs . -0. 55) (P< 0. 001)).
  • At 7 days 8, vision dryness VAS score was statistically significantly improved inside the NOV03 arm compared to control team (LS mean treatment difference, -7. 6; (95% CI: -11. 8 vs. -3. 4) (P< 0. 001).

Key secondary endpoints

  • At Week 2 (day 15), tCFS and eye vaginal dryness VAS score were statistically significant in comparison to saline, with an LS mean treatment distinction (95% CI) for differ from baseline in tCFS of -0. six (-0. 9, -0. 2) (P< 0. 01) plus VAS score of -4. 7 (-8. 2, -1. 2) (P< 0. 01).
  • At Week 8, VAS burning/stinging rating and cCFS also favored the NOV03 group, having an LS mean treatment difference (95% CI) for vary from baseline inside VAS burning/stinging score associated with -5. 5 (-9. five, -1. 6) (P< 0. 01) and cCFS of -0. two (-0. 4, -0. 1) (P< 0. 01).

In the particular study, NOV03 was well tolerated with few subjects experiencing ocular adverse events (AEs) (9. 6% NOV03 group, 7. 5% control group) or treatment-related ocular AEs (6. 3% NOV03 group, three or more. 1% manage group). Most AEs were mild in order to moderate in severity. The particular most common AEs (incidence ≥1%) experienced within the NOV03 group had been blurred vision, mostly mild and transient (3. 0% vs 0. 3%), instillation site pain (1. 0% vs one. 0%), plus eye discharge (1. 0% versus 0. 0%). Ocular AEs led to therapy discontinuation in one subject in the NOV03 group (eye irritation) and three subjects within the saline team (conjunctivitis, dry eye, punctate keratitis).

About NOV03 (perfluorohexyloctane) Ophthalmic Solution

NOV03 is a good investigational, proprietary, water-free, single-component preservative-free attention drop. 5 In 2019, Bausch + Lomb acquired an exclusive license for the commercialization and development of NOV03 in the usa plus Canada. Results from the particular pivotal Phase 2 demo (SEECASE) were published inside Cornea in September 2021. Data from your first crucial Phase 3 trial (GOBI) were presented at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in Washington, D. C. on April 24, 2022. Data through the second pivotal Stage 3 trial (MOJAVE) had been presented at the Association intended for Research within Vision and Ophthalmology (ARVO) annual conference in Denver on May 2, 2022. The clinical program to get NOV03 concluded with the particular completion of a multi-center, open-label, single-arm, 12-month safety extension trial (KALAHARI). In September 2022, Bausch + Lomb and NOV03 announced that the U. S. FDA had accepted the particular NDA filing for NOV03 and designated a PDUFA action day of 06 28, 2023.

About Novaliq

Novaliq is a biopharmaceutical company centering on the development plus commercialization associated with first- and best-in-class ocular therapeutics depending on EyeSol ® , the worldwide first water-free technology. Novaliq offers a good industry-leading portfolio addressing today’s unmet clinical needs of countless sufferers with eyesight diseases. Novaliq GmbH will be headquartered inside Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is usually dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life plus Health Sciences companies. More on www.novaliq.com .

Regarding Bausch + Lomb

Bausch + Lomb is focused on protecting and enhancing the particular gift associated with sight pertaining to millions of people around the world – from the moment of birth through every phase associated with life. Its comprehensive profile of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter items and ophthalmic surgical devices and instruments. Founded within 1853, Bausch + Lomb has the significant global research and development, manufacturing and commercial footprint along with more than 12, 000 employees plus a presence in nearly 100 countries. Bausch + Lomb is definitely 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 plus Instagram .

Forward-looking Statements

This news release may contain forward-looking statements, which usually may generally be identified by the use of the words “anticipates, ” “hopes, ” “expects, ” “intends, ” “plans, ” “should, ” “could, ” “would, ” “may, ” “believes, ” “estimates, ” “potential, ” “target, ” or even “continue” and variations or similar expressions. These statements are based upon the current expectations plus beliefs associated with management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the particular forward-looking statements. These dangers and questions include, but are not limited to, the risks and uncertainties discussed within Bausch + Lomb’s filings with the U. H. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited in order to, risks plus uncertainties caused by or even relating to the evolving COVID-19 pandemic, and the fear of that will pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain plus cannot be predicted, and which may have a material adverse impact on Bausch + Lomb, including but not small to its project development timelines, launches and costs (which might increase). Readers are cautioned not in order to place undue reliance upon any of these forward-looking statements. These types of forward-looking claims speak only as of the particular date hereof. Bausch + Lomb undertakes no obligation to update some of these forward-looking statements to reflect occasions or circumstances after the time of this news release or to reflect actual outcomes, unless required by law.

References

  1. National Eye Institute. Dry Eye. Last updated 04 8, 2022. Accessed December 21, 2022. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/dry-eye
  2. Leonardi, A., Modugno, R. L., & Salami, E. (2021). Allergy and Dried out Eye Disease. Ocular immunology and inflammation , 29(6), 1168-1176. https://doi.org/10.1080/09273948.2020.1841804 .
  3. Lemp, MA, Crews, LA, Bron AJ. (2012). Distribution of Aqueous-Deficient and Evaporative Dry Eye in a Clinic-Based Patient Cohort: a retrospective study. Cornea , 31(5), 472-478. https://journals.lww.com/corneajrnl/Abstract/2012/05000/Distribution_of_Aqueous_Deficient_and_Evaporative.2.aspx
  4. Geerling G, Baudouin Chemical, Aragona P, et al. (2017). Emerging strategies meant for the diagnosis and treatment of meibomian gland disorder: Proceedings from the OCEAN group meeting. The Ocular Surface , 15(2): 179-192. https://doi.org/10.1016/j.jtos.2017.01.006
  5. In December 2019, Bausch Health acquired the rights from Novaliq GmbH in order to pursue advancement and commercialization of NOV03 for DED and combination products based on NOV03 in additional ophthalmic indications in the United States and Canada.

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