Ocular Therapeutix announced positive topline results from its phase 3 clinical trial of Dextenza (dexamethasone insert) 0.4 mg for the treatment of postsurgical ocular inflammation and pain. Dextenza is a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days.
The trial successfully met its two primary efficacy endpoints for inflammation and pain, achieving statistically significant differences between the treatment group and the placebo group for the absence of inflammatory cells on day 14 and the absence of pain on day 8, respectively. In the study, 52.3% of patients treated with Dextenza showed an absence of inflammatory cells in the anterior chamber of the study eye on day 14, compared to 31.1% of those receiving the placebo vehicle control punctum plug (P < 0.0001). And 79.6% of patients treated with Dextenza reported absence of pain in the study eye on day 8, compared to 61.3% of those receiving the placebo vehicle control punctum plug (P < 0.0001). For clarification of the endpoints, the day of surgery and insertion of Dextenza or the placebo is considered to be day 1.
“The successful results of this trial represent an important milestone for the company, and we believe these results not only further validate the ability of Dextenza to provide a full post-operative course of therapy with a one-time administration, but also validate the broader utility of our multi-faceted hydrogel drug delivery technology platform,” Amar Sawhney, PhD, President, Chief Executive Officer and Chairman, said in the news release. “We are preparing for the resubmission to our NDA for Dextenza for the postsurgical ocular pain indication by the end of the year, and subject to potential approval, we plan to submit an NDA supplement for Dextenza to include a postsurgical ocular inflammation indication. This is an exciting time for Ocular Therapeutix, as we advance our lead drug delivery product candidate toward potential commercialization.”
In this phase 3 clinical trial with Dextenza for the treatment of postsurgical ocular inflammation and pain, as well as other Dextenza clinical trials completed to date regardless of indication, Dextenza has exhibited a strong safety profile and has been generally well-tolerated. There were no treatment-related serious adverse events observed in this phase 3 clinical trial. Dextenza inserts were visible in almost all subjects through day 30, with 99% present at the primary efficacy endpoint visits.
Secondary efficacy endpoints included differences between the Dextenza treatment group and the placebo group for the absence of anterior chamber (AC) cells at day 2, 4, 14, and 30 and for the absence of pain at day 2, 4, 14, and 30. All eight of these secondary endpoints were met at a level of statistical significance with the exception of the endpoint for the absence of AC cells at day 2. Additional secondary endpoints including flare, as well as an assessment of all safety data, are being evaluated.
“In parallel with steadily rising ophthalmic surgical volumes among the aging US population is the requirement for safe and effective outcomes, driven not only by operative technique but also by appropriate postoperative drug delivery,” Terry Kim, MD, Chief of the Cornea and External Disease Service at the Duke University Eye Center and Professor of Ophthalmology, Duke University School of Medicine, said in the news release. “Dextenza’s demonstrated ability to provide a full postoperative course of therapy with a single placement is attractive for both patients and physicians. A large majority of my patients show poor compliance and improper technique when using current standard of care steroid eye drops, which can lead to prolonged recovery and suboptimal outcomes as well as unnecessary phone calls and office visits to the physician. Dextenza has the potential to improve both compliance and outcomes, enabling the transfer of control back to the physician for the entire course of therapy.”
Phase 3 Study Design
This prospective, multicenter, 1:1 randomized, parallel-arm, double-masked, vehicle-controlled study was designed to evaluate the safety and efficacy of Dextenza for the treatment of ocular inflammation and pain following ophthalmic surgery. The study enrolled 438 patients who were undergoing clear corneal cataract surgery at 21 sites throughout the United States. Immediately following surgery, patients were randomized to either Dextenza or a placebo vehicle. Primary efficacy endpoints evaluated the differences between the Dextenza treatment group and the placebo group for the absence of anterior chamber cells at day 14 and absence of pain at day 8.
This was the third phase 3 clinical trial that the company has conducted with Dextenza for the treatment of ocular inflammation and pain following ophthalmic surgery. Based on the results from the first two phase 3 clinical trials, Ocular Therapeutix submitted a new drug application (NDA) to the FDA for Dextenza for the treatment of ocular pain occurring after ophthalmic surgery. The purpose of conducting this third phase 3 clinical trial is part of the company’s label expansion strategy for Dextenza. Accordingly, subject to the approval of the NDA for postsurgical ocular pain by the FDA, Ocular Therapeutix intends to submit an NDA supplement for Dextenza to broaden its label to include a postsurgical inflammation indication.