Bausch Health Announces VYZULTA® , 0.024%, is Now Approved In Brazil

- Bausch Health Companies Inc. (NYSETSX: BHC) ("Bausch Health" or the "Company"), Bausch + Lomb, its 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 from the Brazilian Health Regulatory Agency (ANVISA Agência Nacional de Vigilância Sanitária).

VYZULTA is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension in the United States and other territories that have the same indication. 1

"The approval of VYZULTA in Brazil marks its tenth regulatory approval. We will continue to focus our efforts on securing additional regulatory approvals for this important treatment option for people suffering from glaucoma to help address this critical unmet medical need," said Thomas J. Appio , president, Bausch + Lomb/International.

VYZULTA is now approved in 10 markets, including Argentina , Brazil , Canada , Colombia , Hong Kong , Mexico , South Korea , Taiwan , Ukraine and the United States .

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 U.S. full prescribing information here .

About Nicox
Nicox S.A. is an international 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 nitric oxide-donating prostaglandin 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, 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 in the majority of 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: www.nicox.com .

About Bausch + Lomb
Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on helping people see. 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 www.bausch.com .

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 www.bauschhealth.com .

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 2020' filed with the French Autorité des Marchés Financiers (AMF) on March 1, 2021 which are available on Nicox's website ( www.nicox.com ).

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.

References
1 VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% [prescribing information]. Bridgewater, NJ: Bausch & Lomb Incorporated; 2019.

VYZULTA is a trademark of Bausch & Lomb Incorporated or its affiliates.
All other product/brand names and/or logos are trademarks of the respective owners.
© 2021 Bausch & Lomb Incorporated or its affiliates.

Nicox Investor & Media Contact:


Bausch Health Investor Contact:

Gavin Spencer


Art Shannon

communications@nicox.com


arthur.shannon@bauschhealth.com

+33 (0)4 97 24 53 00


(514) 856-3855



(877) 281-6642 (toll free)

Mary-Ann Chang



mchang@lifesciadvisors.com


Bausch Health Media Contact:

+44 7483 284 853


Lainie Keller



lainie.keller@bauschhealth.com

Nicox Media France Contact:


(908) 927-1198

Sophie Baumont



sophie@lifesciadvisors.com



+33 6 27 74 74 49



Bausch Health logo (PRNewsfoto/Bausch Health Companies Inc.)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/bausch-health-announces-vyzulta-latanoprostene-bunod-ophthalmic-solution-0-024-is-now-approved-in-brazil-301270280.html

SOURCE Bausch Health Companies Inc.

News Provided by PR Newswire via QuoteMedia

The Conversation (0)

Glen Eagle Resources Inc.

(TheNewswire)

Glen Eagle Resources Inc.

Glen Eagle Resources Inc. ( TSX VENTURE: GER) ("Glen Eagle" or the "Company")  announces that the court has homologated the judgement, ordering the Company to pay Gem Yield Bahamas Limited a compensation of $1,875,895 dollars including interest and $90,000 in penalty

News Provided by TheNewsWire via QuoteMedia

Keep reading...Show less

Notice of Knight Therapeutics' Fourth Quarter and Year End 2023 Results Conference Call

Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-USA) specialty pharmaceutical company, will release its fourth quarter and year end 2023 financial results on Thursday, March 21, 2024 prior to market opening. Following the release, Knight will hold a conference call and audio webcast. Knight cordially invites all interested parties to participate in this call.

Date : Thursday, March 21, 2024

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
CardieX Limited

Funding Commitment Agreement Update

CARDIEX Limited (ASX:CDX) (CARDIEX, the Company) provides an update on the Funding Commitment Agreement (FCA) with C2 Ventures Pty Limited (C2V, owned by Directors Niall Cairns and Craig Cooper) as announced on 8 November 2023.

Keep reading...Show less

Orchestra BioMed Demonstrates Strength of Cardiovascular Pipeline with Virtue® SAB and AVIM Therapy Presentations at CRT 2024 Annual Meeting

  • New pharmacokinetic data demonstrate Virtue ® SAB enables extended release of sirolimus above required tissue concentrations in target arterial sites without polymer degradation or detectable remaining polymer within 90 days of balloon delivery
  • AVIM therapy presentation highlighted recent clinical results showing favorable hemodynamic effects and long-term reduction in 24-hour ambulatory systolic blood pressure, as well as the design of the BACKBEAT global pivotal study now enrolling in collaboration with Medtronic, plc (NYSE:MDT)

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced two oral presentations were given at the Cardiovascular Research Technologies ("CRT") 2024 Meeting in Washington, D.C. One presentation featured new preclinical pharmacokinetic ("PK") data on Virtue ® Sirolimus AngioInfusion Balloon ("SAB"), a novel drug-eluting balloon angioplasty system designed to deliver a proprietary, extended-release formulation of sirolimus, SirolimusEFR™ to the vessel wall during balloon angioplasty without any coating on the balloon surface. A second presentation featured recently reported clinical data on atrioventricular interval modulation ("AVIM") therapy (also known as BackBeat CNT), an investigational therapy delivered via standard dual-chamber pacemakers designed to immediately, substantially and persistently lower blood pressure. The AVIM presentation also outlined the design of the currently enrolling BACKBEAT global pivotal study evaluating AVIM therapy in hypertensive pacemaker patients in collaboration with Medtronic.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

New real-world data shows MiniMed 780G system sustains strong global performance, exceeding international targets for diabetes management

New data presented at ATTD demonstrates the system's ability to help individuals with type 1 diabetes exceed international targets on outcome measures

Medtronic plc. (NYSE: MDT), a global leader in healthcare technology, today shared a robust set of new clinical and real-world evidence on the MiniMed™ 780G system from around the world including the largest set of data from early users in the United States . The data was presented at the 17 th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Florence, Italy . These results build on the 3-year data published in Diabetes Technology & Therapeutics showing over 100,000 real-world users achieving a Time in Range (TIR) of 78% with the use of recommended optimal settings, outperforming international targets of 70% TIR.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Medtronic announces cash dividend for fourth quarter of fiscal year 2024

Board authorizes $5 billion for share repurchases

The board of directors of Medtronic plc (NYSE: MDT) on Thursday, March 7, 2024 approved the company's cash dividend for the fourth quarter of fiscal year 2024 of $0.69 per ordinary share. This quarterly declaration is consistent with the dividend announcement made by the company in May 2023.  Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 46 consecutive years. The dividend is payable on April 12, 2024 to shareholders of record at the close of business on March 22, 2024 .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×