Ocular Therapeutix announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) of Dextenza (dexamethasone insert) 0.4mg for the intracanalicular treatment of ocular pain after ophthalmic surgery.
The CRL included concerns raised by the FDA regarding deficiencies in manufacturing process and controls that were identified during a pre-NDA approval inspection of the manufacturing facility. No efficacy or safety issues on clinical data were identified in the letter.
The FDA cannot approve the NDA until the manufacturing deficiencies achieve satisfactory resolution. Ocular Therapeutix is responding to the FDA’s requests to address these concerns and is working collaboratively with the agency to finalize the NDA review.
Dextenza Intracanalicular Depot is designed to deliver dexamethasone to the ocular surface for up to 30 days. In addition to the post-surgical ocular pain indication, the Company is also developing Dextenza for post-surgical ocular inflammation, ocular itching associated with allergic conjunctivitis, and signs and symptoms associated with inflammatory dry eye disease.
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