Ocular Therapeutix™ Announces Submission to the FDA of a Supplemental New Drug Application for DEXTENZA® (dexamethasone ophthalmic insert) for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis

IndustryPRwire - Ocular Therapeutix announced the submission of the supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use. If approved, this sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA.

“We are excited to share the allergic conjunctivitis data with the FDA and feel this sNDA supports an expanded label. If approved, the sNDA would reflect the second expansion of the DEXTENZA label and would include the first indication for DEXTENZA treated primarily in the ophthalmology office setting,” said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. “It is estimated that up to 10 million1,2,3 people in the U.S. annually seek medical attention for the inflammatory response associated with allergic conjunctivitis caused by both seasonal and perennial allergens, representing a discrete and significant potential market for DEXTENZA beyond its current use in the surgical setting. From a business perspective, ocular itching associated with allergic conjunctivitis is our first potential indication in the treatment of an ocular surface disease, paving the way for our two Phase 2 clinical programs in the treatment of dry-eye disease.”

The efficacy of DEXTENZA for the treatment of ocular itching was evaluated in four vehicle-controlled clinical trials for subjects with a positive history of ocular allergies and positive skin test reaction to perennial and seasonal allergens (n=323). The sNDA offers data that Ocular believes supports that DEXTENZA demonstrated superiority to placebo vehicle for the treatment of ocular itching due to allergic conjunctivitis as evidenced by statistically significant differences in a pooled analysis of three well controlled Phase 3 clinical trials as well as in the Phase 2 clinical trial. At the primary endpoint for the pooled analysis of the three Phase 3 clinical trials (Day 8), ocular itching scores favored DEXTENZA treated subjects compared with placebo vehicle treated subjects at all three timepoints: 3 min (1.85 vs 2.55, p value = <0.0001 ), 5 min (1.90 vs 2.63, p value = <0.0001 ) and 7 min (1.84 vs 2.61, p value = <0.0001 ). In addition, it is submitted that treatment with DEXTENZA consistently resulted in lower ocular mean itching scores relative to placebo vehicle at all other study visits throughout the duration of the respective studies.

DEXTENZA was observed to have a favorable safety profile and be generally well-tolerated in the allergic conjunctivitis, ocular inflammation and pain clinical program populations. The most common ocular adverse events seen in the pooled analysis of the allergic conjunctivitis studies were: increased intraocular pressure (n=6), increased lacrimation (n=2), eye discharge (n=2) and reduced visual acuity (n=2). The most common non-ocular adverse events seen were: headache (n=2), nasopharyngitis (n=1), gastroenteritis viral (n=1), dermatitis contact (n=1), and oropharyngeal pain (n=1).

“The use of topical steroids is an important part of the clinical armamentarium in the treatment of a patient with allergic conjunctivitis,” said Michael Goldstein, MD, MBA, Chief Medical Officer of Ocular Therapeutix. “As DEXTENZA is physician-administered and can’t be overused by patients, it provides a potentially safer method of steroid delivery. In addition, unlike current therapeutic options, DEXTENZA is a preservative-free steroid which may be a benefit for patients with allergic conjunctivitis who already have a compromised ocular surface.“

The Company has received acceptance of the sNDA submission to the FDA and anticipates a target action data under the Prescription Drug User Fee Act, commonly known as PDUFA, in October of 2021.

About DEXTENZA

DEXTENZA 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 in three Phase 3 clinical trials and a Phase 2 clinical trial evaluating DEXTENZA for the treatment of post-surgical inflammation and pain of the eye prior to its approval. Overall, 567 subjects were exposed to DEXTENZA in such clinical trials. 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%).

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