Bausch + Lomb Announces HEALTH CANADA Approval Of VYZULTA™ (latanoprostene Bunod Ophthalmic Solution, 0.024%) for the Treatment of Glaucoma

LAVAL, QC, Jan. 3, 2019 /CNW Telbec/ - Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health (NYSE : BHC) (TSX : BHC) today announced that on December 27, 2018, Health Canada issued the Notice of Compliance (NOC) for VYZULTA™ (latanoprostene bunod ophthalmic solution, 0.024%). VYZULTA™, the first prostaglandin analog with one of its metabolites being Nitric Oxide (NO), is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.ⁱ VYZULTA™ is the first new innovative treatment for open-angle glaucoma in Canada in almost twenty years.

"More than 250,000 Canadians have glaucoma, which is a chronic disease that results in vision loss over time. Ninety percent of all glaucoma cases are primary open-angle glaucoma (POAG)ⁱⁱ," says Richard Lajoie, president, Bausch Health, Canada. "With today's approval of VYZULTA™, doctors and patients with glaucoma now have a new innovative treatment option that can help provide consistent and sustained IOP reduction. High IOP is the only modifiable risk factor that can help slow down the progression of the disease to help patients maintain healthy vision."

Anti-glaucoma medications work to reduce IOP, which is a major modifiable risk factor for glaucoma progression. Reduction of intraocular pressure reduces risk of glaucomatous visual field loss.

VYZULTA™, the first once daily monotherapy with a dual mechanism of action, which targets two pathways to reduce aqueous humor to lower IOP. Following topical administration, VYZULTA™ is thought to lower intraocular pressure by increasing outflow of aqueous humor through both uveoscleral and trabecular meshwork routes.ⁱⁱⁱ The innovative treatment is rapidly metabolized in the eye to latanoprost acid (main active metabolite), an F2α prostaglandin analogue, and likely butanediol mononitrate.^iv

The most common ocular adverse events include conjunctival hyperemia, eye irritation, eye pain and instillation site pain. Increased pigmentation of the iris and periorbital tissue and growth of eyelashes can occur.

"VYZULTA™, (latanoprostene bunod 0.024) represents an evolution in topical monotherapy in Canada in the treatment of glaucoma," says Dr. Ike Ahmed, assistant professor, University of Toronto; clinical professor, University of Utah; director, Glaucoma & Advanced Anterior Segment Surgery (GAASS) Fellowship, University of Toronto; and research director, Kensington Eye Institute, University of Toronto. "It is a unique molecule that targets two outflow pathways to improve IOP reduction. I am pleased to see that a recognized eye care company like Bausch + Lomb is investing in innovative research to advance the treatment of glaucoma ultimately to help eye care providers and their patients to preserve sight."

"The dual mechanism of action of latanoprostene bunod ophthalmic solution 0.024 offers glaucoma patients a new option for the treatment of intraocular pressure associated with glaucoma," says Mahadeo Sukhai, head of research and chief accessibility officer, Canadian National Institute of the Blind (CNIB).

About Bausch + Lomb
Bausch + Lomb, a Bausch Health Companies Inc. company, is a leading global eye health organization that is solely focused on helping people see better to live 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 www.Bausch.ca.

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. 

In Canada, our areas of focus include eye health, dermatology and cardio-metabolic. We are delivering on our commitments as we build an innovative company dedicated to advancing the health of Canadians. More information can be found at www.BauschHealth.ca. 

References

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ⁱ VYZULTA™ Product Monograph, page three.
ⁱⁱ Canadian National Institute of the Blind (CNIB): https://cnib.ca/en/sight-loss-info/your-eyes/eye-diseases/glaucoma?region=on
ⁱⁱⁱ VYZULTA™ Product Monograph, page nine.
^iv VYZULTA™ Product Monograph, page ten.

 

SOURCE Bausch + Lomb

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