Amar Sawhney, Chief Executive Officer and chairman of Bedford, MA-based Ocular Therapeutix, Inc., which recently announced encouraging top-line results from exploratory Phase 2 trial for DEXTENZA™ in patients with inflammatory dry eye disease, rang the opening bell on Nasdaq on December 14th. Ocular is a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye.
Ocular said in a statement that trial was intended to explore which measures would be appropriate to include in the design of a future clinical trial to evaluate efficacy of DEXTENZA or other molecules in a sustained release product as a potential therapy for dry eye disease.
“We are encouraged that DEXTENZA showed improvements in the important and highly relevant efficacy measures of total and inferior corneal staining in this exploratory study. It is apparent that DEXTENZA exhibited a global effect across all regions on the cornea, particularly the inferior region, which is generally considered to be the most susceptible region of the cornea for the onset of dry eye disease,” said Sawhney. “We intend to advance this important clinical program to expand DEXTENZA’s potential for this highly unmet need. Inflammatory dry eye is one of the most common ophthalmic disorders affecting approximately 20 million people in the United States, for which novel treatments are needed. With the results from this exploratory trial, we are now positioned to pursue the further development of DEXTENZA for inflammatory dry eye disease.”
The Phase 2 exploratory clinical trial was a prospective, multicenter, randomized, parallel-arm, bilateral, double-masked, vehicle controlled study to explore the safety and efficacy of DEXTENZA for the treatment of subjects exhibiting signs and symptoms of moderate to severe dry eye disease. The trial was conducted at two sites in the United States that included 43 patients (86 eyes) and was not powered for statistical significance. Designed as a serial phase study, patients were initially administered a placebo vehicle depot for 45 days to establish a baseline for the investigational drug treatment. Patients who responded to the placebo vehicle depot, i.e., showed benefit from punctal occlusion alone, were excluded from the treatment phase of the study. Qualifying patients who continued to exhibit signs and symptoms of dry eye during the initial 45 days were enrolled in the treatment phase of 30 days, randomized to receive either DEXTENZA or a placebo vehicle in a 1:1 ratio, the statement said.
DEXTENZA is a product candidate administered by a physician as a bioresorbable intracanalicular depot and designed for extended drug release to the ocular surface for 30 days. Ocular Therapeutix is developing DEXTENZA for a broad range of front of the eye conditions. In September 2015, the Company filed an NDA with the Food and Drug Administration (FDA) for DEXTENZA for the treatment of post-surgical ocular pain and a PDUFA date of July 24, 2016 has been set by the FDA. The Company is conducting a third Phase 3 clinical trial to potentially broaden its indication to include post-surgical ocular inflammation and pain. After a successful initial Phase 3 study for the treatment of allergic conjunctivitis, a second Phase 3 clinical trial is currently enrolling for DEXTENZA for this additional indication.
Dry eye disease affects the ocular surface and is characterized by dryness, inflammation, pain, discomfort, and irritation. Dry eye is a complex, multifactorial disease which can present differently in patients, and becomes more common with age. Due to the prevalence of the disease, over $1.5 billion was spent on treatment of the disease in the United States alone in 2014 in both prescription and artificial tear products (IMS Health). One cause of the disease is inflammation of the ocular surface resulting from a patient’s immune response. Although physicians may prescribe topical steroid eye drops for the treatment of dry eye disease, chronic use of topical steroids can lead to elevations in intraocular pressure, which is a risk factor for glaucoma. DEXTENZA only contains approximately 7% of the amount of active dexamethasone compared with eye drop therapy, resulting in an improved safety profile. Conversely, patients often do not reliably self-administer these drops, which can lead to eye irritation and continual, if not more, inflammation.