Dextenza delivers corticosteroid to the ocular surface without the drop.

Today’s cataract surgery is technologically advanced and extremely safe, allowing patients to enjoy improved vision and enhance their quality of life. Still, surgeons, staff and patients lament the burden of traditional postoperative corticosteroid drop regimens, as compliance is frequently a challenge for patients and a source of worry for surgeons.

Patients struggle with drops in many ways. The cataract-age population can be hampered by forgetfulness, arthritis or limited dexterity, making proper instillation technique and dosing difficult. The result of poor compliance is suboptimal outcomes due to postoperative pain and/or inflammation — and an unhappy patient with a poor cataract surgery experience.

NEW METHOD TREATS PAIN

In late 2018, the FDA approved Dextenza (dexamethasone ophthalmic insert [0.4 mg], Ocular Therapeutix) to treat ocular pain following ophthalmic surgery. The preservative-free insert liberates patients from complicated tapering schedules while ensuring the delivery of a consistent and tapered dose of drug to the ocular surface. The surgeon places the intracanalicular insert through the punctum and into the canaliculus, where drug delivery occurs for up to 30 days. Following treatment, Dextenza softens and resorbs, exiting through the nasolacrimal system. There is no need for removal; however, the insert can be irrigated out or expressed if necessary.

That “liberating” feature is particularly appreciated by Alice T. Epitropoulos, MD, FACS, in practice at Ophthalmic Surgeons and Consultants of Ohio at The Eye Center in Columbus, Ohio, and a clinical assistant professor at The Ohio State University. “Most patients prefer using the fewest drops possible,” she notes. “Traditionally, patients require multiple drops several times a day in tapering fashion. I will inform patients Dextenza is a new delivery system that reduces the burden of administering drops in a complex, tapering, several-times-a-day regimen over the course of a month.”

ONE INSERT OR 70 DROPS?

During a 30-day postoperative cataract medication regimen, a patient instills approximately 70 corticosteroid drops.^1,2 Dextenza replaces those drops with a one-time, physician-administered insert that offers built-in compliance. The FDA approved the insert based on its demonstrated efficacy in two randomized, vehicle-controlled Phase 3 studies (n=488).^3,4 A statistically significantly higher incidence of patients reported being pain free eight days after cataract surgery, compared to the vehicle control group. Safety was also established in the two Phase 3 studies as well as a third randomized, vehicle-controlled Phase 2 study.^3,4 A survey found that a majority of patients rated the insert as very or extremely comfortable.⁵

SEEKING ANOTHER NOD

On the heels of the approval, Ocular Therapeutix submitted a supplemental New Drug Application (sNDA) to the FDA seeking to expand Dextenza’s current indication to include treating ocular inflammation after ophthalmic surgery. The company expects the FDA review to be completed in the second half of this year.

The previous Phase 3 Dextenza trials support the sNDA along with efficacy data from a Phase 3c trial that included 438 patients.⁴ The insert demonstrated statistically significant superiority compared to vehicle control for both primary endpoints: absence of ocular pain at day 8 and absence of inflammation at day 14. Fourteen days after implantation, significantly more patients had an absence of anterior chamber cells in the treatment arm compared with placebo (52.3% vs 31.1%).

The investigators also reported that Dextenza patients had statistically significantly less inflammation as soon as three days after surgery and statistically significantly less pain as soon as one day after surgery. The insert was well tolerated, they noted, with adverse events similar to placebo.

FAST, SAFE AND EASY

Sydney Tyson, MD, MPH, the principal investigator for Dextenza, says he was impressed with the quick onset of action demonstrated by the percentage of patients who reported being pain free one day after surgery. “It is also notable that only one patient out of 538 patients across all three Phase 3 studies experienced an IOP increase attributed to the product,” says Dr. Tyson, president of Eye Associates and SurgiCenter of Vineland, N.J.

Insertion is easy. “Because the insert is conjugated with fluorescein, surgeons can visualize the Dextenza in place using blue light with a yellow filter,” he explains. “With the insert, we can be confident that medication is onboard and under our control, with a single, preservative-free, dose of dexamethasone for up to 30 days.”

Another key factor in the study was Dextenza’s ease of use, Dr. Tyson says. “Dextenza’s removability provides peace of mind that, if I have a steroid responder, it is easy to take it out through manual expression or saline irrigation.”

A WELCOME OBSOLESCENCE

Ocular Therapeutix applied to Centers for Medicare & Medicaid Services for transitional pass-through payment status and a J-code.

The company believes Dextenza has the potential to dramatically change the conversation around the postoperative cataract surgery drop dilemma. Like thick, clunky “Coke” bottle-thick hyperopic glasses, surgeons and patients alike are rooting for frequent dosing and complicated tapering regimens to become obsolete.

“I like the idea of using the fewest drops possible so we don’t aggravate the ocular surface and we become less concerned about non-compliance,” says Dr. Epitropoulos. “The answer lies in delivery vehicles, specifically a sustained-release vehicle.” OM

REFERENCES

1. Durezol [package insert]. Fort Worth TX: Novartis; 2016.
2. Lotemax gel [package insert]. Bridgewater, NJ: Bausch + Lomb Inc; 2016
3. Walters T, Bafna S, Vold S, et al. Efficacy and safety of a sustained release dexamethasone insert for the treatment of ocular pain and inflammation after cataract surgery: results from two phase 3 studies. J Clin Exp Ophthalmol. 2016;7:4. http://tinyurl.com/y44qgdsm . Accessed March 11, 2019.
4. Tyson SL, Bafna S, Gira JP, et al. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019;45:204-212. https://www.ncbi.nlm.nih.gov/pubmed/?term=Tyson+SL%2C+Bafna+S%2C+Gira+JP . Accessed March 11, 2019.
5. Gira JP, Sampson R, Silverstein SM, et al. Evaluating the patient experience after placement of a 0.4-mg dose dexamethasone intracanalicular insert (Dextenza): results of a qualitative study. Presented at the Annual ASCRS 2017 Meeting, May 7, 2017; Los Angeles.