Ocular Therapeutix (NSDQ:OCUL) said today that its post-surgical ocular pain reliever, Dextenza, met both primary endpoints in a pivotal trial for the treatment of post-surgical ocular inflammation and pain. The product is a bioresorbable intracanalicular insert, designed for drug release to the ocular surface for up to 30 days.
The randomized, double-masked study enrolled 438 patients who were undergoing clear corneal cataract surgery at 21 sites throughout the U.S to compare the Dextenza insert with a sham control procedure.
Dextenza met its 2 primary efficacy endpoints for inflammation and pain, according to the Bedford, Mass.-based company. More than half of the patients treated with Dextenza showed an absence of inflammatory cells in the anterior chamber of the eye on day 14, compared to 31% of the patients who received the placebo vehicle control punctum plug. Over 75% of patients with Dextenza reported absence of pain on day 8, compared to 61% of the control group.
The insert also met its safety endpoints, as there were no treatment-related serious adverse events reported in the trial. The Dextenza inserts were visible in almost all participants throughout the 30 day trial, with 99% present at the primary efficacy endpoint visits.
“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,” president, chairman & CEO Amar Sawhney said in prepared remarks. “We are preparing for the resubmission to our [new drug application] for Dextenza for the post-surgical 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 post-surgical ocular inflammation indication. This is an exciting time for Ocular Therapeutix, as we advance our lead drug delivery product candidate toward potential commercialization.”
“In parallel with steadily rising ophthalmic surgical volumes among the aging U.S. population is the requirement for safe and effective outcomes, driven not only by operative technique but also by appropriate post-operative drug delivery,” addedDr. Terry Kim of the Duke University School of Medicine. “Dextenza’s demonstrated ability to provide a full post-operative 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.”
OCUL shares were trading at $7.64 in afternoon activity, up 11.2%.