Manufacturing issues thwart FDA approval for Valeant eye drug

Valeant HQ

It had been a good week for Valeant ($VRX) after an FDA panel backed its skin drug brodalumab and then the regulator gave the thumbs up for an oral version of its constipation drug Relistor. But its good fortune has come to an end as the FDA has today rejected an approval for its experimental eye drug.

The Canadian company, which is trying to reform itself after a torrid year, said in a brief statement that the FDA sent the company a complete response letter in regards to its NDA for Vesneo (latanoprostene bunod ophthalmic solution).

The company was seeking an approval for its med, made in conjunction with its Bausch + Lomb unit, as a once-daily treatment for patients with open angle glaucoma or ocular hypertension.


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But the FDA has singled out Bausch + Lomb--which originally licensed the drug from ophthalmic specialist NicOx ($COX)--as being the culprit behind its rejection. The PDUFA date was yesterday after the FDA accepted its submission last September.

In a statement from Valeant, it said: “The concerns raised by the FDA pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida where some deficiencies were identified by the FDA.”

No more details were given on what these deficiencies were, or a timeline for a resubmission. Valeant said it “intends to meet with the FDA as soon as possible to work on a resolution and address these concerns.”

The company was quick to point out that the FDA was not worried about the safety of efficacy of the trials it sent along with its submission, and will not need to undertake any further costly and time-consuming studies.

This comes a few months after the FDA sent a complete response letter to AstraZeneca ($AZN) and its recently acquired biotech ZS Pharma for their experimental hyperkalemia drug ZS-9.

This too centered on concerns over the manufacturing issues coming out of ZS Pharma and has delayed the potential approval of ZS-9 by around a year.

And it’s not the first problem in 2016 for Valeant and Bausch + Lomb: In February, the two had to undertake a massive recall of an eye dilation med after learning that more than 1 million bottles may have been shipped with the wrong medication insert.

Shares in NicOx were down by more than 15% this morning, while Valeant was trading down by 2% premarket. 

NicOx believes peak sales of the therapy could reach at least $500 million in the U.S. and $1 billion globally. The French company has previously said it would exercise its option to co-promote Vesneo in the U.S.

- read Valeant’s statement

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