Bausch Health Co. Inc. (BHC) Reports Brazilian Approval for VYZULTA

April 16, 2021 7:03 AM EDT

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Bausch Health Companies Inc. (NYSE: BHC), 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 USAGEVYZULTA® (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%)


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