Caution: NEW DRUG – DEXTENZA is currently undergoing clinical evaluation in the United States and is limited by United States law to investigational use only. This product has not been approved by the FDA as safe or effective.
DEXTENZA™ is placed through the punctum, a natural opening in the eye lid, into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days. Following treatment, DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.
DEXTENZA is able to provide a complete course of post-operative steroid therapy with a one-time administration, enabling the transfer of control back to the physician for the entire course of therapy leading to improved compliance by the patient. The Company has completed three Phase 3 clinical trials with DEXTENZA for the treatment of post-surgical ocular pain and inflammation. In February 2017, the U.S. Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) resubmission for DEXTENZA for intracanalicular use, for the treatment of ocular pain occurring after ophthalmic surgery, and assigned a target action date under the Prescription Drug User Fee Act (PDUFA) of July 19, 2017. Ocular Therapeutix intends to submit an NDA supplement for DEXTENZA to broaden its label to include a post-surgical inflammation indication.
About Post-operative Inflammation and Pain
Post-operative pain is a common side effect following any ophthalmic surgery. Due to this, physicians prescribe anti-inflammatory therapies, such as corticosteroids, following ocular surgery as the standard of care. This not only helps manage the symptoms, but also provides faster recovery for the patient. Approximately 8.5 million corticosteroid prescriptions were filled in 2014.2 However, steroid regimens are complex, leading to issues with patient compliance and may also cause spikes in intraocular pressure with chronic use, which can lead to drug-induced glaucoma. According to Market Scope, over 5.6 million ocular surgeries were performed in the United States in 2016.3
Steroid-loaded intracanalicular insert may be able to treat post-operative inflammation without causing spikes in intraocular pressure. Additionally, the one-time administration may improve compliance and convenience, resulting in better disease control.
About Allergic Conjunctivitis
When eyes are exposed to allergens, histamine is released and the blood vessels in the conjunctiva swell, making the eyes itch, tear and redden. Antihistamine or anti-inflammatory drops are often prescribed to relieve discomfort. Topical steroid drops, which prevent certain white blood cells from releasing histamine, are prescribed for more severe cases. These drops are sometimes prescribed in conjunction with antihistamines and work best if taken prior to coming into contact with the allergen. Approximately 6.9 million anti-allergy prescriptions, consisting of anti-histamines, mast-cell stabilizers and corticosteriods, were prescribed in 2014.4
DEXTENZA is also being investigated for the treatment of allergic conjunctivitis. Ocular Therapeutix has released topline results of two Phase 3 clinical trials designed to assess the effect of DEXTENZA compared to placebo on allergic reactions using three series of successive allergen challenges over a 30-day period. The Company plans to conduct a non-signiﬁcant risk (NSR) study to conﬁrm the effect on efﬁcacy of the placebo insert used in previous studies compared with a rapidly absorbing placebo insert. Pending favorable results from this study, the Company plans to conduct an additional Phase 3 clinical trial to further evaluate DEXTENZA for the treatment of allergic conjunctivitis.
1 “Market Research Outcomes 10 Standard of Care DEXTENZA 79% Other 21% 79% of Ophthalmologists stated that DEXTENZA™ could become new standard of care Understanding the Opportunity for DEXTENZA™ in Ophthalmology Practices Working Insights, n=42 ophthalmologists IDIs. Krog and Partners, March.”
2-4 Quintiles Health – Market Research