BAUSCH HEALTH ANNOUNCES VYZULTA® (LATANOPROSTENE BUNOD OPHTHALMIC SOLUTION), 0.024%, IS NOW APPROVED IN SOUTH KOREA
February 9, 2021
SOPHIA ANTIPOLIS, France, and LAVAL, Quebec, Feb. 9, 2021 – 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 from the Ministry of Food and Drug Safety in South Korea.
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]
“VYZULTA is an important treatment option for people suffering from glaucoma, and we are committed to securing additional regulatory approvals for VYZULTA in countries around the world,” said Thomas J. Appio, president, Bausch + Lomb/International. “Bausch + Lomb remains focused on bringing forward innovative eye health treatment options to help address unmet medical needs around the world.”
VYZULTA is now approved in nine markets, including Argentina, 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 full prescribing information here.
[1] VYZULTA® [prescribing information]. Bridgewater, NJ: Bausch & Lomb Incorporated; 2019.