Ocular has announced that it has resubmitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Dextenza (dexamethasone insert) 0.4mg, to treat ocular pain after ophthalmic surgery.
If approved, Dextenza would be administered by a physician as a bioresorbable intracanalicular insert designed to release drug to the ocular surface for up to 30 days. The resubmission comes after the FDA’s complete response letter in July 2016 identified some deficiencies in manufacturing processes 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,” said Amar Sawhney, PhD, CEO of Ocular.
The FDA review period of the NDA resubmission will be up to two months if a Class 1 (minor review) designation is received and up to six months in the case that Class 2 (major review) designation is received. Class designation is dependent on whether an FDA re-inspection of the manufacturing facility will be a condition of NDA approval.
Three Phase 3 trials of Dextenza have been completed investigating the drug in treating post-surgical ocular inflammation and pain. Dextenza is also in Phase 3 development for the treatment of ocular itching associated with allergic conjunctivitis.
For more information visit Ocutx.com.