Dextenza reduces ocular itching scores in allergic conjunctivitis
Dextenza demonstrated a statistically significant mean change in ocular itching scores from baseline in patients with allergic conjunctivitis, according to a press release from Ocular Therapeutix.
Ninety-six participants were enrolled in a phase 3 randomized, double-masked, parallel-arm, placebo-controlled clinical trial at six sites in the United States. The primary endpoint was ocular itching measured on a 5-point scale at three prespecified time points on day 8 after implantation. The trial included patients with seasonal and perennial allergies.
Mean itch scores, on a scale of 0 to 4, at 3 minutes, 5 minutes and 7 minutes post-challenge on day 8 after insertion of Dextenza (dexamethasone ophthalmic insert 0.4 mg) were 1.82, 1.73 and 1.74, respectively. The mean itch scores for patients treated with vehicle were 2.67, 2.71 and 2.69, respectively, a statistically significant difference at all time points (P < .0001).
For the secondary endpoints, subjects treated with Dextenza had statistically significantly (P < .05) lower ocular itching scores at 19 of 20 time points.
Dextenza had a favorable safety profile and was well-tolerated with no serious adverse events.
“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,” Michael Goldstein, MD, chief medical officer of Ocular Therapeutix, said in the release. “Even in normal times, the hassle of using topical eye drops for patients and the worry of noncompliance 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.”
Perspective
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Dextenza is a very promising treatment for ocular allergy because the punctal insert delivers a slow, steady dose of dexamethasone to the surface of the eye for at least several weeks. While it is currently indicated only for treating postoperative inflammation and pain, it would also be perfect for combating seasonal allergy symptoms. Its very favorable topline results are not surprising and will hopefully lead eventually to an expansion of its approved use for allergy. This would mean that not just ophthalmologists but also optometrists could use this medication for a common form of ocular surface disease.