COX Nicox SA

BAUSCH HEALTH ANNOUNCES VYZULTA® (LATANOPROSTENE BUNOD OPHTHALMIC SOLUTION), 0.024%, IS NOW APPROVED IN SEVEN COUNTRIES

BAUSCH HEALTH ANNOUNCES VYZULTA® (LATANOPROSTENE BUNOD OPHTHALMIC SOLUTION), 0.024%, IS NOW APPROVED IN SEVEN COUNTRIES



Nicox Investors & Media Contact:


Gavin Spencer



+33 (0)4 97 24 53 00



Mary-Ann Chang



3



Nicox Media France Contact:

Sophie Baumont



49



Investor Contact:

Art Shannon



(514) 856-3855

(877) 281-6642 (toll free)



               
Media Contact:

Lainie Keller



 (908) 927-1198

 

                                                                                               



BAUSCH HEALTH ANNOUNCES VYZULTA® (LATANOPROSTENE BUNOD OPHTHALMIC SOLUTION), 0.024%, IS NOW APPROVED IN SEVEN COUNTRIES

Recent Access Wins Also Make VYZULTA Available To More Americans and Canadians

SOPHIA ANTIPOLIS, France, and LAVAL, Quebec, Sept. 24, 2020 – Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”), Bausch + Lomb, a leading global eye health business, and Nicox (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, has received regulatory approval in Ukraine, bringing the total number of countries where VYZULTA is approved to market to seven. These countries include Argentina, Canada, Hong Kong, Mexico, Taiwan, Ukraine and the United States.

In Canada, VYZULTA also now has public drug reimbursement in the provinces of Alberta, Saskatchewan, Manitoba, New Brunswick, Newfoundland and Labrador and Nova Scotia, and as part of the federal Non-Insured Health Benefits. These provinces join Ontario, which made VYZULTA available to patients in December 2019.

Additionally, due to a recent formulary change in the United States, Medicare Part D coverage of VYZULTA increased in the United States to approximately 45% up from approximately 30%1 earlier this year. VYZULTA is indicated in the United States for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.2

“We are committed to continuing to secure additional regulatory approvals in multiple markets around the world, as well as working to increase access and availability for VYZULTA, because it is an important

treatment option for people suffering from glaucoma,” said Joseph C. Papa, chairman and CEO, Bausch Health.





Indication and Important Safety Information about VYZULTA



INDICATION AND USAGE

VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.



IMPORTANT SAFETY INFORMATION

  • Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent
  • Gradual changes to eyelashes, including increased length, increased thickness, and number of eyelashes, may occur. These changes are usually reversible upon treatment discontinuation
  • Use with caution in patients with a history of intraocular inflammation (iritis/uveitis). VYZULTA should generally not be used in patients with active intraocular inflammation
  • Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin analogs. Use with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema
  • There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products that were inadvertently contaminated by patients
  • Contact lenses should be removed prior to the administration of VYZULTA and may be reinserted 15 minutes after administration
  • Most common ocular adverse reactions with incidence ≥2% are conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%)

Please see full prescribing information .



About Nicox

Nicox S.A. is an ophthalmology company developing innovative solutions to help maintain vision and improve ocular health.  Nicox’s lead program in clinical development is NCX 470, a novel, second-generation nitric oxide-donating bimatoprost analog, for lowering intraocular pressure in patients with glaucoma.  The company is also developing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis. Nicox generates revenue from VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch & Lomb Incorporated and ZERVIATE™ in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and Southeast Asian markets. Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes. For more information on Nicox, its products or pipeline, please visit: .

About Bausch + Lomb

Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on helping people see better. Its core businesses include over-the-counter products, dietary supplements, eye care products, ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. Bausch + Lomb develops, manufactures and markets one of the most comprehensive product portfolios in the industry, which is available in more than 100 countries. For more information, visit .  

About Bausch Health

Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at .

Nicox Forward-looking Statements

The information contained in this document may be modified without prior notice.  This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance.  These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.  Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements. Risks factors which are likely to have a material effect on Nicox’s business are presented in the 3rd chapter of the ‘Document d’enregistrement universel, rapport financier annuel et rapport de gestion 2019’ filed with the French Autorité des Marchés Financiers (AMF) on March 6, 2020 which are available on Nicox’s website ().

Bausch Health Forward-looking Statements

This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “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 Health’s most recent annual report on Form 10-K and detailed from time to time in Bausch Health’s other 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 Health, including but not limited to its project development timelines, 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 Health 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.

###

VYZULTA is a trademark of Bausch & Lomb Incorporated or its affiliates.

© 2020 Bausch & Lomb Incorporated or its affiliates.


VYZ.0198.USA.20






1 Managed Markets Insight & Technology, LLC database as of September 2020

2 VYZULTA® [prescribing information]. Bridgewater, NJ: Bausch & Lomb Incorporated; 2019.

 

 

Attachment

EN
24/09/2020

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Nicox SA

 PRESS RELEASE

Nicox Completes NCX 470 New Drug Application Key Data Generation for S...

Nicox Completes NCX 470 New Drug Application Key Data Generation for Submission as Planned in H1 2026 Press Release Nicox Completes NCX 470 New Drug Application Key Data Generation for Submission as Planned in H1 2026 All clinical trial and long-term stability data required for the preparation of the New Drug Applications (NDA) has been generated and analysedPre-NDA meeting1 with the U.S. Food and Drug Administration (FDA) in preparation; U.S. NDA submission on-track as planned in H1 2026 Submission of NDA in China similarly on track for 2026 December 16, 2025 – release at 7:30 am CETSophia...

 PRESS RELEASE

Nicox finalise la génération des données clés de demande d’autorisatio...

Nicox finalise la génération des données clés de demande d’autorisation de mise sur le marché de NCX 470 pour un dépôt maintenu au premier semestre 2026 Communiqué de presseNicox finalise la génération des données clés de demande d’autorisation de mise sur le marché de NCX 470 pour un dépôt maintenu au premier semestre 2026 Toutes les données d’ essais cliniques et de stabilité à long terme requises pour la préparation des demandes d’autorisation de mise sur le marché (NDA), ont été générées et analyséesRéunion pré-NDA1 avec la Food and Drug Administration (FDA) américaine en préparation ; ...

 PRESS RELEASE

Nicox Provides First Half 2025 Financial Results

Nicox Provides First Half 2025 Financial Results Press Release Nicox Provides First Half 2025 Financial Results  New Drug Application (NDA) submissions for NCX 470 expected in 2026 in the U.S. and ChinaCompany believes that it can finance its existing operations for at least 12 months and expects to fully repay existing financial debts in 2026 October 23, 2025 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided the financial results for Nicox SA (the “Company”) for the first half of 2...

 PRESS RELEASE

Nicox : Résultats financiers du premier semestre 2025

Nicox : Résultats financiers du premier semestre 2025 Communiqué de presseNicox : Résultats financiers du premier semestre 2025  Les dépôts de demande d’autorisation de mise sur le marché (NDA) pour NCX 470 sont attendues en 2026 pour les Etats-Unis et la ChineLa Société estime qu’elle peut financer ses opérations pendant au moins 12 mois et prévoit de rembourser intégralement ses dettes financières existantes en 2026 23 octobre 2025 – publication à 7H30Sophia Antipolis, FranceNicox SA (Euronext Growth Paris : FR0013018124, ALCOX, éligible PEA-PME), une société internationale spécialisée ...

 PRESS RELEASE

Nicox’s NCX 470 Demonstrates Sustained Efficacy through 12 Months in D...

Nicox’s NCX 470 Demonstrates Sustained Efficacy through 12 Months in Denali Clinical Trial with no new Safety Observations Press Release Nicox’s NCX 470 Demonstrates Sustained Efficacy through 12 Months in Denali Clinical Trial with no new Safety Observations Additional pre-planned analysis of the NCX 470 Denali trial completed NCX 470 maintains robust intraocular pressure lowering at 6, 9 and 12 monthsOther analyses broadly in line with the trends seen for Mont BlancData presentations planned for upcoming ophthalmology conferences October 2, 2025 – release at 7:30 am CETSophia Antipo...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch