Ocular Therapeutix announced the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for DEXTENZA to include the treatment of ocular inflammation following ophthalmic surgery as an additional indication. With the approval of the sNDA, DEXTENZA is now approved for the treatment of both ocular inflammation and pain following ophthalmic surgery.
DEXTENZA is the first FDA-approved intracanalicular insert, a novel route of administration that delivers drug to the surface of the eye without the need for eye drops. DEXTENZA is a preservative-free, resorbable hydrogel insert that delivers 0.4mg of dexamethasone to treat post-surgical ocular inflammation and pain for up to 30 days with a single administration. DEXTENZA originally received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery.
“We could not be more excited about both the approval and its earlier-than-expected timing,” said Antony Mattessich, the Company’s President and Chief Executive Officer. “With our C-Code and pass-through payment status effective on July 1, the expanded indication gives us tremendous momentum as we approach our commercial launch.”
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The approval of the sNDA is supported by three Phase 3 randomized, vehicle-controlled trials; patients received DEXTENZA or a vehicle immediately upon completion of cataract surgery. In all three trials, DEXTENZA had, at a statistically significant level, a higher proportion of patients than the vehicle group who were pain free on post-operative Day 8. On post-operative Day 14, in two of the three studies, DEXTENZA had a higher proportion of patients than the vehicle group, at a statistically significant level, who had an absence of anterior chamber cells.
DEXTENZA is a corticosteroid indicated for the treatment of ocular pain following ophthalmic surgery. DEXTENZA is inserted into the lower lacrimal punctum into the canaliculus by the physician following ophthalmic surgery. A single DEXTENZA releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. DEXTENZA is preservative free, resorbable and does not require removal. Saline irrigation or manual expression can be performed to remove the insert, if necessary.
DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella; mycobacterial infections; fungal diseases of the eye; and dacryocystitis. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during the course of the treatment. Corticosteroids may suppress the host response to, and increase the hazard for and severity of, secondary bacterial, viral, or fungal infections. The use of steroids after cataract surgery may delay wound healing and increase the incidence of bleb formation.
Safety was assessed from the three Phase 3 clinical trials and a Phase 2 clinical trial. Overall, 567 subjects were exposed to DEXTENZA. The most common ocular adverse reactions in subjects treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (10%), increased intraocular pressure (6%), reduced visual acuity (2%), cystoid macular edema (1%), corneal edema (1%), eye pain (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse event was headache (1%).