Manufacturing has for the second time stepped on Ocular Therapeutix’s chance of an FDA approval for its new drug for pain following eye surgery.
The Bedford, Massachusetts, biotech today said the FDA has issued it a second complete response letter after finding more issues at its manufacturing facility there. The CRL comes almost exactly a year after the FDA first nixed its approval chances for Dextenza because of manufacturing problems. Its share price fell 30% on the news.
Ocular Therapeutix CEO Amar Sawhney pointed out in a statement today that there no clinical concerns raised in the CRL. “We are evaluating the FDA’s response and plan to work closely with the agency in an effort to satisfy the requirements related to the NDA,” Sawhney said. “We believe that Dextenza can be approved once these open manufacturing items are resolved.”
Signs that Ocular Therapeutix’s second go-around was unlikely to work out any better arose in May when the company acknowledged the FDA had issued another Form 483 during a recently completed reinspection of its manufacturing processes. In its first-quarter earnings report, the company said the FDA had concerns about those processes and analytical testing.
Ocular tried to head off a second CRL when on Monday it presented the FDA with an amendment to its NDA outlining a manufacturing equipment change it intends to make and asking that the FDA consider delaying the pending target date.
But that was a no-go for the FDA. Instead, in its CRL, the agency acknowledged getting the amendment but said it did not review it before issuing the CRL. It did say the company could include “applicable sections of the amendment...when responding to deficiencies noted in the CRL.”
A growing list of manufacturing-related CRLs have been issued to companies over the last several years, even though the agency insists it is no more focused on manufacturing processes than in years past when evaluating new drug approvals.
Ocular Therapeutix is not alone in having received two CRLs tied to manufacturing. AstraZeneca in March received a second CRL tied to the manufacturing of ZS 9, a potential blockbuster treatment for hyperkalemia that was the target of its $2.7 billion buyout of ZS Pharma in 2015.