BLOG: Real-world data provide insights into Dextenza safety, patient characteristics

ByMichael Mbagwu, MD

Fact checked byChristine Klimanskis, ELS

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Two abstracts showcased at the American Academy of Ophthalmology annual meeting utilized the IRIS Registry to provide insights into real-world treatment patterns and safety outcomes of patients treated with Dextenza.

Dextenza (dexamethasone ophthalmic insert 0.4 mg, Ocular Therapeutix) is indicated for the treatment of ocular inflammation and pain following ophthalmic surgery.

By relying on curated, deidentified IRIS Registry data managed by Verana Health’s VeraQ population health data engine, research teams identified approximately 3.7 million real-world cataract patients, including thousands who received Dextenza following cataract surgery, as well as hundreds of thousands of patients with similar clinical characteristics who had cataract surgery alone.

Without such data curation, spearheaded by Verana Health, the data and analytics partner of the Academy, research of this scale would likely take longer, reflect a less recent patient demographic and may not include all eligible patients.

Real-world safety

Robert Chang, MD, and colleagues performed a retrospective analysis of the IRIS Registry to compare real-world safety outcomes of patients who received Dextenza (n = 10,313 eyes) following cataract surgery with those who did not (n = 425,098 eyes). All patients in the study underwent cataract surgery alone from June 2019 (ie, immediately after the launch of Dextenza) to March 2021.

The two cohorts experienced similar inflammatory event profiles in the postoperative period, with some small differences in adverse events:

• The Dextenza arm and the non-Dextenza arm demonstrated low and comparable rates of inflammation events (ie, anterior, intermediate, posterior and other uveitis).
• Both arms had low and comparable rates of cystoid macular edema (1.26% vs. 0.63% for Dextenza arm and non-Dextenza arm, respectively), epiphora (0.71% vs. 0.21%), corneal edema (0.50% vs. 0.58%) and lacrimal disorders (0.50% vs. 0.11%).
• The percentage of patients with IOP elevations of 10 mm Hg or greater was comparable in the Dextenza arm and non-Dextenza arm among patients without a history of glaucoma at days 1 (7.5% vs. 8.7%, respectively) and 29 (0.6% vs. 0.9%); Dextenza and non-Dextenza arms were also comparable among patients with a history of glaucoma at days 1 (8.7% vs. 8.5%, respectively) and 29 (1.2% vs. 1.5%).
• Rates of endophthalmitis were low in both the Dextenza cohort (0.09%) and the non-Dextenza cohort (0.08%).

By leveraging the IRIS Registry to provide a large, real-world patient population, the overall safety profile for Dextenza was examined and found to be similar to the safety profile of non-Dextenza patients.

Patient demographics

In a separate study, my colleagues and I examined the demographic profiles of the same patients identified in the safety study. This allowed us to better understand which types of real-world patients underwent Dextenza therapy in the 22 months after this treatment’s launch.

Among the 10,313 patients who underwent therapy with Dextenza, we found that:

• Dextenza was used more frequently in patients with dry eye disease and ocular surface conditions compared with the non-Dextenza cohort (32.1% vs. 24.5%), suggesting a potential prescriber preference in patients with dry eye or ocular surface diseases.
• Nearly all (99.2%) of Dextenza inserts were documented to have been used on the same day as surgery.
• Dextenza was used in patients with a concurrent glaucoma surgery (25.5% of all surgeries).
• The proportion of patient eyes with age-related macular degeneration, nonproliferative and proliferative diabetic retinopathy, diabetic macular edema and other ocular comorbidities was similar among eyes that received Dextenza and those that did not.
• Mean patient age was approximately 73.4 years.
• Approximately 75% of patients were Medicare beneficiaries, and approximately 59% of patients were women.

Real-world data helping to drive important insights

Based on this research, we have a better understanding of the safety profile and clinical characteristics of patients who receive Dextenza. Surgeons and researchers now have a more complete picture of real-world practice dynamics, including the frequency at which Dextenza was used during glaucoma surgery and the prescribing preference for this treatment in patients with ocular surface concerns, which may further inform decision-making.

References:

• Chang RT, et al. Real-world safety analysis of an intracanalicular dexamethasone insert using the American Academy of Ophthalmology’s IRIS Registry (Intelligent Research in Sight). Presented at: American Academy of Ophthalmology meeting; Sept. 30-Oct. 3, 2022; Chicago.
• Chang R, et al. Real-world safety analysis of an intracanalicular dexamethasone insert using the IRIS Registry (Intelligent Research in Sight). Presented at: American Society of Cataract and Refractive Surgery meeting; April 22-26, 2022; Washington.
• Dextenza prescribing information. https://www.dextenza.com/wp-content/uploads/DEXTENZA-Full-Prescribing-Information.pdf. Updated October 2021. Accessed Dec. 13, 2022.
• Mbagwu M, et al. Real-world characteristics of patients treated with intracanalicular dexamethasone insert: An IRIS Registry analysis 2019-2021. Presented at: American Society of Cataract and Refractive Surgery meeting; April 22-26, 2022; Washington.
• Mbagwu M, et al. Real-world patient demographics and clinical characteristics of an intracanalicular dexamethasone insert using the Academy’s IRIS Registry (Intelligent Research in Sight). Presented at: American Academy of Ophthalmology meeting; Sept. 30-Oct. 3, 2022; Chicago.
• The power of real-world data to detect adverse events and expedite FDA postmarking safety commitments. https://info.veranahealth.com/verana-health-ocular-therapueutix-white-paper. Accessed Dec. 13, 2022.

Published by: