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US FDA Approves Ocular Therapeutix Supplemental New Drug Application for Dextenza 0.4 mg for Intracanalicular Use for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
12 October 2021 - - The US Food and Drug Administration has approved US-based biopharmaceutical company Ocular Therapeutix, Inc's (NASDAQ: OCUL) Supplemental New Drug Application to broaden the Dextenza label to add an additional indication for the treatment of ocular itching associated with allergic conjunctivitis, the company said.

With the approval, Dextenza is the first, FDA-approved, physician-administered intracanalicular insert capable of delivering a preservative-free drug for the treatment of ocular itching associated with allergic conjunctivitis with a single administration for up to 30 days.

Dextenza originally received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery, followed by an expansion of the label to also include the treatment of ocular inflammation following ophthalmic surgery in June 2019.

The efficacy of Dextenza for the treatment of ocular itching associated with allergic conjunctivitis was based on three randomized, multicenter, double-masked, parallel group, vehicle-controlled studies in subjects with a positive history of ocular allergies and positive skin test reaction to perennial and seasonal allergens (n=255). In all three trials, Dextenza demonstrated lower mean ocular itching scores compared with the vehicle group at all time points throughout the study duration of up to 30 days.

In two of the three studies, a higher proportion of patients had statistically significant reductions in ocular itching on Day eight, at three minutes, five minutes and seven minutes post-challenge in the Dextenza group compared to the vehicle group.

Data for the primary endpoint, ocular itching at Day eight, is shown below for all three studies (scale 0-4):
Dextenza was observed to have a favorable safety profile and be generally well-tolerated in the allergic conjunctivitis as well as the ocular inflammation and pain clinical populations.

The most common ocular adverse events seen in the pooled analysis of the allergic conjunctivitis studies were: increased intraocular pressure, increased lacrimation, eye discharge and reduced visual acuity.

The most common non-ocular adverse reaction that occurred in patients treated with Dextenza for allergic conjunctivitis was headache.

An estimated 10m people in the US annually seek medical attention for the inflammatory response associated with allergic conjunctivitis caused by both seasonal and perennial allergens, representing a discrete market opportunity for Dextenza beyond its current use in the surgical setting.

Dextenza is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis.

Dextenza is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.

Dextenza is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis.

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology.

Ocular Therapeutix's first commercial drug product, Dextenza, is an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis.

Ocular Therapeutix's earlier stage development assets currently in Phase 1 clinical trials include OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases and OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.

Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease in Phase 2 clinical trials.

Ocular Therapeutix's first product, ReSure Sealant, is an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery.


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