Shares in Ocular Therapeutix (NSDQ:OCUL) fell last week after the company revealed that it received another letter from the FDA about issues spotted by the regulatory agency during a pre-approval inspection of a manufacturing plant.
This isn’t the first time that the company has dealt with manufacturing issues. In July last year, the FDA denied approval for Ocular’s hydrogel plug, Dextenza, after it discovered “deficiencies in manufacturing process and controls” in a pre-new drug application approval inspection.
The Bedford, Mass.-based company’s device is designed to deliver a sustained dosage of dexamethasone over 4 weeks following ophthalmic surgery. The FDA is slated to make an approval decision for Dextenza by July 19.
The manufacturing issues brought about in the latest note from the FDA include problems relating to process controls.
“Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity,” the FDA wrote.
“There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Specifically, your firm lacks documentation to show that your product can consistently meet specifications as you have not systemically evaluated the [redacted] lots manufactured from FEB2016 to present, of which [redacted] failed specification and were disposed of in-process.”
Ocular has also experienced big changes to its personnel recently, including the departure of its president & CEO Amarpreet Sawhney.
In its latest earnings call, the company said that it is addressing the issues detailed in Dextenza’s initial rejection. Ocular also pointed out that the second inspection was conducted by a different investigator than the first inspection.
“Also remembering that this is a new investigator, different one that came last time. So when you have a different one coming, they confirm what the prior one did, and then they probably have some additional helpful suggestions,” Sawhney reportedly said.
OCUL shares were trading at $6.29 apiece in mid-morning activity today, down -11.9%.
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