FDA approves new indication for treating ocular itching

USA – The FDA has approved Ocular Therapeutix’s Dextenza (dexamethasone 0.4 mg), an intracanalicular insert for the treatment of allergic conjunctivitis.

Ocular Therapeutix, Inc. a biopharmaceutical company focused on the formulation, development, and commercialization of novel therapies for eye diseases and conditions.

The approval of the new indication was based on the findings of three randomized, multicenter, vehicle-controlled studies involving 255 patients with a history of ocular allergies and a positive skin test reaction to perennial and seasonal allergens.

Dextenza now becomes 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 for up to 30 days with a single administration.

Dextenza provides an opportunity for physicians to alleviate their patients of the burden of administration of their post-operation steroid drop regimen.

Following ocular surgery, physician-administered sustained-release anti-inflammatory agents have several advantages over patient-administered topical therapy.

Patient adherence to postoperative regimens is the most significant barrier to optimal control of postoperative inflammation and Dextenza offers a sustainable solution to this setback.

The preservative-free intracanalicular inserts can replace the need for patients to administer approximately 70 steroid eye drops, thereby increasing patient’s adherence as guaranteed in the eyes of the sustained-delivery platform.

The therapy is designed in such a way as to deliver a gradually increasing dose of steroid (dexamethasone) to the ocular surface for up to 30 days. It then resorbs and exits the nasolacrimal system without the need for removal after treatment.

An estimated 10 million people seek medical attention in the United States each year for the inflammatory response associated with allergic conjunctivitis caused by both seasonal and perennial allergens.

This large population represents a distinct market opportunity for Dextenza beyond its current use in the surgical setting.

“Allergic conjunctivitis is a common condition seen in the offices of eye care providers. We are really excited about this label expansion and the potential benefits for patients,” commented Michael Goldstein, MD, President, Ophthalmology and Chief Medical Officer.

“The use of topical steroids is an important part of our current clinical armamentarium in the treatment of allergic conjunctivitis. Dextenza can now provide an office-based, physician-administered, preservative-free method of steroid delivery that benefits patients with ocular itching associated with allergic conjunctivitis,” Goldstein added.

Ocular Therapeutix is applying its hydrogel implant technology to a number of other pipeline products in addition to Dextenza. Another dexamethasone insert, OTX-DED, is used to treat episodic dry eye disease.

The company is also testing OTX-TKI for wet age-related macular degeneration, which includes Pfizer’s VEGF inhibitor Inlyta.

However, Ocular suffered a setback earlier this year when Regeneron canceled a collaboration to develop a sustained-release version of the blockbuster anti-VEGF drug Eylea.

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