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
PDUFA Target Action Date Anticipated for
“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
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
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.
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%).
Please see Important Safety Information and full Prescribing Information at www.DEXTENZA.com.
1 Leonardi A, Castegnaro A, Valerio ALG, Lazzarini D. Epidemiology of allergic conjunctivitis: clinical appearance and treatment patterns in a population-based study. Curr Opin Allergy Clin Immunol. 2015;15(5):482-488.
2 Rosario N, Bielory L. Epidemiology of allergic conjunctivitis. Curr Opin Allergy Clin Immunol. 2011;11(5):471-476
3 Ora website, An Update on Ocular Allergy Trends, 2019
Forward Looking Statements
Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company’s product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company’s product candidates, such as the Company’s development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the potential receipt of a target action date under PDUFA; the ongoing development of the Company’s extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company’s product candidates; the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company’s cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s scientific approach and general development progress, the availability or commercial potential of the Company’s product candidates, the Company’s ability to generate its projected net product revenue on the timeline expected, if at all, the sufficiency of cash resources, the Company’s existing indebtedness, the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, the outcome of the Company’s ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company’s and relevant regulatory authorities’ operations, the need for additional financing or other actions and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the
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