Vyzulta Approved for Glaucoma, Ocular Hypertension
November 2, 2017 – The U.S. FDA has approved Vyzulta™ (latanoprostene bunod ophthalmic solution 0.024%), distributed by Bausch + Lomb, a wholly owned subsidiary of Valeant Pharmaceuticals. Vyzulta is indicated to lower intraocular pressure (IOP) in patients who have open-angle glaucoma or ocular hypertension (a risk factor for glaucoma). The drug promotes the drainage of aqueous humor, a transparent fluid that fills the anterior and posterior chambers of the eye, which are located behind the cornea and the iris, respectively. The aqueous humor is responsible for maintaining proper intraocular pressure, as well as multiple other functions. Excessive accumulation of aqueous humor can damage the optic nerve and lead to vision loss. Reduction of intraocular pressure, even in patients with normal IOP, may help to reduce or prevent vision loss caused by glaucoma.
Side effects of Vyzulta include changes to the pigmentation of the iris and eyelid, with changes in iris color typically being permanent. Vyzulta may also cause changes in the length, number, and thickness of eyelashes, an effect that usually reverses when treatment with the drug is discontinued. Recommended dosing is one drop in the affected eye per day, during evening hours.
Vyzulta, which was previously licensed to Pfizer, is currently licensed to Bausch + Lomb by Nicox S.A. for global distribution. Plans for pricing and launch are not yet available.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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