Ocular Therapeutix Inc (NASDAQ: OCUL) shares took a pounding Wednesday, after the company reported that it has received a complete response letter (CRL) from the FDA for DEXTENZA NDA. The FDA said that it cannot approve the DEXTENZA NDA in its present form.
The whole reason for the rejection was due to manufacturing issues with respect to a plant inspection that was performed during a pre-NDA approval inspection in May.
The CRL acknowledges receipt of the Company’s NDA amendment dated July 10, and states that the amendment was not reviewed prior to the FDA’s action of the CRL. As a result, the FDA did not have the opportunity to review the Company’s close-out response prior to issuing the CRL. In addition, as noted in the CRL, the FDA indicated that applicable sections of the amendment submitted by Ocular Therapeutix could be incorporated when responding to deficiencies noted in the CRL.
DEXTENZA is placed through a natural opening in the eye lid, into the canaliculus and is designed to deliver dexamethasone without preservatives to the ocular surface for up to 30 days. Following treatment, DEXTENZA resorbs and exits the nasolacrimal system without need for removal.
Ocular, based in Bedford, Massachusetts, is a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology.
Shares in the company thundered lower $1.14, or 15%, Wednesday, to $6.46, within a 52-week trading range of $4.04, to $11.91.
