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Ocular Therapeutix Launches Dextenza 0.4 mg for Ophthalmic Use in the United States.


- US-based biopharmaceutical company Ocular Therapeutix, Inc. (NASDAQ: OCUL) has undertaken the commercial launch in the United States of Dextenza (dexamethasone ophthalmic insert) 0.4 mg for the treatment of ocular inflammation and pain following ophthalmic surgery, the company said.

Dextenza is the first US Food and Drug Administration -approved intracanalicular insert, a drug product with a novel route of administration that enables the delivery of drug to the surface of the eye, obviating the need for a burdensome, monthly regimen of steroid eye drops. Dextenza originally received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery.

The launch comes less than two weeks after the June 21st announcement of FDA approval of a Supplemental New Drug Application for Dextenza for the treatment of ocular inflammation following ophthalmic surgery.

According to the company, Dextenza is now the only sustained release steroid product approved for the treatment of both ocular inflammation and pain following ophthalmic surgery.

The initial launch of Dextenza is supported by activation of its C-code, C9048. A C-code is a product code established by CMS for the Hospital Outpatient Prospective Payment System (HOPPS) used to report claims for hospital outpatient department and ambulatory surgical center services and procedures.

The July 1, 2019 activation of the C-code facilitates the reimbursement of Dextenza until such time as CMS may potentially approve a J-code and such approval becomes effective.

In May 2019, the company announced that CMS has included Dextenza on its list of products that have been preliminarily recommended for a new dedicated Healthcare Common Procedure Coding System (HCPCS) J-code which, if granted, would become effective January 1, 2020. A J-code represents a permanent product code that could be used across settings of care.

There are approximately six m steroid prescriptions written each year for ocular surgeries in the US Ocular's commercial launch of Dextenza will initially focus on the roughly two m cataract procedures performed annually under Medicare Part B which is the market segment where Dextenza has full reimbursement established following the effectiveness of the C-code and pass-through payment status.

Dextenza (dexamethasone ophthalmic insert) 0.4mg is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. 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.

The safety of Dextenza was assessed from 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, increased intraocular pressure, reduced visual acuity, cystoid macular edema, corneal edema, eye pain, and conjunctival hyperemia. The most common non-ocular adverse event was headache.

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.

Ocular Therapeutix is a biopharmaceutical company focused on the formulation, development, and commercialisation of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology.
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Publication:M & A Navigator
Date:Jul 8, 2019
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