This is the second time that Ocular has received the FDA’s dreaded complete response letter for Dextenza. In July last year, the FDA denied approval for Ocular’s hydrogel plug 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 company reported that the latest rejection from the FDA also cited manufacturing deficiencies, which the company made public last week.
“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,” president & CEO Amar Sawhney said in prepared remarks. “Importantly, there were no clinical issues identified in the CRL pertaining to efficacy or safety related to the post-surgical pain indication. We believe that Dextenza can be approved once these open manufacturing items are resolved.”
Just yesterday, Ocular filed an amendment to its NDA, asking the FDA to delay making a decision for Dextenza since the company changed some of its manufacturing equipment.
Ocular has also experienced big changes to its personnel recently, including the planned departure of its president & CEO. Antony Mattessich was named president & CEO in place of Sawhney, effective Sept. 18.
OCUL shares were trading at $6.08 apiece in mid-morning activity, down -20%.