The effort to reorganize comes just weeks after the FDA rejected Ocular’s resubmitted new drug application for its hydrogel plug, Dextenza.
Ocular said it expects to finish restructuring in the third quarter of this year and that it will likely incur a cost of $1.5 million, including severance, benefits and related costs.
Also yesterday, Antony Mattessich officially took over Ocular’s corner office. The company announced in June that its founder, Amarpreet Sawhney, planned to step down as president and CEO, assuming the role of executive chairman.
Ocular’s device is designed to deliver a sustained dosage of dexamethasone over 4 weeks following ophthalmic surgery. But the company has faced obstacles in its path to regulatory approval in the U.S.
It has twice 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.
Manufacturing problems were also cited in this year’s rejection. Days before the FDA denied approval for Dextenza, Ocular filed an amendment to its NDA and requested an extension to its regulatory timeline, citing changes to its manufacturing equipment.