Ocular Therapeutix resubmits Dextenza to FDA seeking approval for post-surgical ocular pain

Ocular Therapeutix on Monday said it resubmitted Dextenza (dexamethasone) to the FDA seeking approval for the treatment of ocular pain occurring after ophthalmic surgery. The agency declined to approve the drug last year after identifying deficiencies in manufacturing process and controls. 

"If Dextenza is approved, we believe that its ability to provide a complete course of steroid therapy with one-time administration in the post-surgical setting will be extremely attractive for both ophthalmologists and patients," commented Ocular CEO Amar Sawhney, adding "we continue to build our commercial organization and infrastructure in preparation for the earliest possible launch of Dextenza, subject to marketing approval." 

Ocular indicated that it expects to receive clarification from the FDA regarding the scope and timing of its review within 30 days. The company explained that the review period for its resubmitted application could be up to two months or six months depending on whether the FDA requires a re-inspection of the drugmaker's manufacturing facility as a condition of approval. 

Ocular noted that it completed three Phase III clinical studies assessing Dextenza in the treatment of post-surgical ocular inflammation and pain, including study data unveiled earlier this month. Meanwhile, the drugmaker said that subject to approval of the drug for the treatment of post-surgical ocular pain, it intends to expand the indication of Dextenza to include post-surgical inflammation.