FDA Rejects Valeant Glaucoma Drug, Raises Concerns Over Manufacturing Issues
July 22, 2016
By Alex Keown, BioSpace.com Breaking News Staff
LAVAL, Quebec – Shares of Valeant Pharmaceuticals are dropping this morning after the company’s experimental glaucoma drug was rejected by the U.S. Food and Drug Administration due to manufacturing practices at a Florida facility.
The beleaguered company issued a statement this morning saying it had received a Complete Response Letter from the FDA regarding its New Drug Application for Vesneo (latanoprostene bunod), an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. In its rejection letter, federal regulators did not cite concerns over efficacy or safety of the drug, Valeant said, but did raise unspecified deficiencies at the Florida manufacturing facility operated by Valeant’s at Bausch & Lomb division. If it is ultimately approved, Vesneo will be the first nitric oxide donating prostaglandin receptor agonist available for the two disorders. Bausch & Lomb licenses Vesneo from NicOx S.A. Some analysts have suggested the drug could become a global blockbuster with more than $1 billion in annual sales. Shares of Nicox are also down this morning following the FDA rejection.
Open angle glaucoma is the most common form of the eye disease, impacting about 1 percent of people in the United States. Eyes that have the disease see an increase in the amount of pressure, but without swelling in the cornea, which makes the disease easy to miss. If it goes undetected, the disease can cause blindness. Ocular hypertension is a term to describe elevated intraocular pressure. Elevated intraocular pressure is an important risk factor for glaucoma. Common drugs used to treat these issues include Timolol, which has been listed as an essential medicine by the World Health Organization and bimatoprost, which includes Allergan ’s Lumigan drops.
Valeant said it intends to meet with the FDA to work on a resolution and address the concerns raised.
Valeant’s at Bausch & Lomb division is one of the company’s core pillars. Valeant, one of the recent kings of M&A activity, snapped up Bausch & Lomb in 2013 for $8.7 billion. The company, known for its contact lens and lens-care products, generates about $1.5 billion in annual revenue.
This is not the first problem Valeant’s Bausch & Lomb has had this year. In February, the company issued a voluntary recall of more than 1 million bottles of tropicamide ophthalmic solution (a pupil dilator) due to problems with the labeling and packaging. According to a report from Pharma News, the insert was missing updates “compared with the reference drug insert.” The recall applied to multiple lots and strengths.