Bausch Health Companies and Nicox 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 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 10th 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.