Valeant wins approval of eye drug that FDA rejected twice over manufacturing problems

Valeant
Valeant Pharmaceuticals has finally won approval of an eye drug for which it twice received complete response letters tied to manufacturing shortcomings at the Bausch + Lomb plant where it is manufactured.

Joseph Papa, who was brought in to clean up the mess at Valeant Pharmaceuticals, has even worked some magic on a Bausch & Lomb manufacturing plant, winning the drugmaker a novel drug approval in the process. The FDA Thursday approved the company’s long-delayed eye drug latanoprostene bunod ophthalmic solution.

Tagged Vyzulta, the solution was approved for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The company expects to have the drug to market before the end of the year, Papa said in a statement.

The approval comes after Valeant received two complete response letters tied to manufacturing problems at the Bausch + Lomb plant in Tampa, Florida, the last one in August and the first a year earlier. The CRLs resulted from serious reservations the FDA had about the plant’s laissez-faire approach to investigating out-of-spec issues.

Valeant got the drug in its $8.7 billion buyout of Bausch + Lomb in 2013. The drug was licensed to Bausch + Lomb by France-based Nicox.

Before all of the plant problems emerged, former Valeant CEO Michael Pearson had said the new drug had the potential to reach blockbuster sales. But whether those sales will accrue to Valeant or another company is a question since Papa is reportedly trying to sell the eye product specialist to raise cash to pay down debt.

RELATED: Valeant, searching for cash, nears $2B sale of its Bausch & Lomb surgery business

Whoever ends up with Vyzulta, its approval is a feather in the cap of Papa, who was hired, and who has installed a new executive team, to dig the drugmaker out of the debt and legal problems left behind from Pearson’s tenure.

Those difficulties were summed up recently in a lawsuit brought by New Jersey mutual fund Lord Abbett & Co., which alleges securities violations, mail and wire fraud, and racketeering under RICO, a provision that suggests criminal behavior and allows for tripling damages.

RELATED: Fund's $80B Valeant losses prompt lawsuit calling company a criminal enterprise

The drug approval is good news for Irvine, California-based biotech Aerie Pharmaceuticals, whose approval for its own eye drug candidate, Rhopressa, has been delayed by problems with the B+L plant in Tampa where it is being made. Aerie has a February 2018 PDUFA date.