BAUSCH HEALTH ANNOUNCES VYZULTA (LATANOPROSTENE BUNOD OPHTHALMIC SOLUTION), 0.024%, IS NOW APPROVED IN SEVEN COUNTRIES
September 24, 2020
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 here.
[1] Managed Markets Insight & Technology, LLC database as of September 2020
[2] VYZULTA® [prescribing information]. Bridgewater, NJ: Bausch & Lomb Incorporated; 2019.