We believe our product DEXTENZA for AC has potential as a hands-free therapy administered in the office setting as a bioresorbable, intracanalicular insert, designed to release the corticosteroid dexamethasone to the ocular surface for up to 30 days. In the Phase 3 trial, DEXTENZA met all pre-specified primary endpoints as demonstrated by a statistically significant mean change in ocular itching from baseline, on a subject-reported 5-point scale, at three time points on Day 8.
“We are thrilled with the results from the Phase 3 clinical trial and believe the data highlights a compelling product profile that could potentially change the current standard of care with a one-time, long-acting, hands-free, therapy for the treatment of allergic conjunctivitis,” said Michael Goldstein, MD, Chief Medical Officer. “The allergic conjunctivitis market is currently dominated by topical antihistamine/mast cell stabilizers. There is a large unmet need for a potent, hands-free and preservative-free topical anti-inflammatory medication for those subjects who need more than what it is currently available to them. Even in normal times, the hassle of using topical eye-drops for patients and the worry of non-compliance for physicians are problematic. In the era of COVID-19, having a full course of steroid treatment in a single physician-administered insert that doesn’t require patients to touch their face multiple times per day is an even greater breakthrough.”
“Approximately 10-15 % of my allergic conjunctivitis patients are not adequately controlled with current therapy and thus require use of topical steroids. This patient group comprises commonplace seasonal and perennial allergic conjunctivitis as well as more severe atopic and vernal keratoconjunctivitis,” stated Ken Kenyon, MD, an investigator in the DEXTENZA trial and Clinical Professor of Ophthalmology at Tufts / New England Eye Center. “Having a potent and effective anti-inflammatory medication to personally administer in the office setting without concern for patient compliance or potential misuse would be a great addition to my therapeutic toolbox.”
The Phase 3 randomized, double-masked, parallel-arm, placebo-controlled clinical trial enrolled 96 subjects and was conducted across 6 sites in the U.S. using Ora, Inc.’s modified Conjunctival Allergen Challenge (Ora-CAC) Model. The primary efficacy measure for this trial was ocular itching on Day 8 at 3 minutes, 5 minutes and 7 minutes post-challenge and included subjects with seasonal and perennial allergens. The trial’s primary endpoint was ocular itching measured on a 5-point scale (0 to 4) at three pre-specified time points on Day 8 (PM), 1 week after insertion of DEXTENZA. DEXTENZA-treated subjects demonstrated a statistically significant (p<0.0001) change in ocular itching from baseline at all three pre-specified time points (Table 1). An assessment of the secondary endpoint of ocular itching at all other visits (Day 7, Day 8 (AM), Day 8 (PM, 10 minutes following exposure), Day 14, and Day 15 (AM and PM)) also showed that DEXTENZA-treated subjects had lower itching scores than vehicle-treated subjects at 3 minutes, 5 minutes, 7 minutes and 10 minutes post-CAC (p<.05 for all 21 time points except Day 7 at 3 minutes).
DEXTENZA was observed to have a favorable safety profile and be well-tolerated with no serious adverse events observed (ocular or non-ocular). No subjects required rescue medication and no subjects experienced elevated intraocular pressure. There were 8 ocular treatment emergent adverse events in this trial (2 in the DEXTENZA group and 6 in the vehicle group).
These data are consistent with what has been observed in prior Phase 2 and Phase 3a clinical trials using a similar repeat CAC model. The Company believes that the totality of the efficacy and safety data across the Phase 2 trial and the three Phase 3 trials (n = 323 subjects) represent a compelling package for discussion with the U.S. Food and Drug Administration (FDA) for the treatment of ocular itching associated with AC. This package is also supported by the safety data associated with the prior approval of DEXTENZA for the treatment of inflammation and pain following ophthalmic surgery. The Company will continue to assess additional secondary endpoints over the next several weeks. Upon completion of this review, the Company intends to request a meeting with the FDA to discuss the potential submission of a supplement to its existing new drug application for DEXTENZA to include the treatment of ocular itching associated with AC as an additional approved indication.
“It is estimated that up to 10 million people in the U.S. 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,” said Antony Mattessich, the Company’s President and Chief Executive Officer. “In addition to managing the various facets of symptoms associated with AC, we believe that this potential product also addresses physicians’ desire for an abuse-deterrent steroid and patients’ desire for a hands-free solution. From a business perspective, ocular itching associated with AC represents the first indication for DEXTENZA that will be administered in the office setting and is our first potential indication in the large ocular surface disease market. The commercial potential for DEXTENZA in the treatment of ocular surface diseases like AC and episodic dry eye is greater than its potential in the surgical setting.”
Source: Company Press Release