BLOG: Real-world evidence and the IRIS Registry

ByTheodore Leng, MD, FACS

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The American Academy of Ophthalmology IRIS Registry is a centralized data repository that leverages the expanded use of electronic health records to collect real-world data that can be used to improve patient care and outcomes.

The IRIS Registry, which debuted in 2014, experiences widespread participation by practicing ophthalmologists. More than 70% of U.S. ophthalmologists participate in the IRIS Registry, and the database currently houses more than 367 million patient encounters from more than 65 million unique patients.

In this blog, I’ll explore how the Academy and its data curation and analytics partner, Verana Health, are making use of this massive collection of data.

Theodore Leng

If your practice’s EHR is already integrated with the IRIS Registry, then you may be aware of the benefits of data contribution. Participation in the IRIS Registry fulfills government requirements for data reporting, which could help elevate your Merit-based Incentive Payment System, or MIPS, score.

As you can imagine, the massive volume of information in the IRIS Registry requires detailed organization by data experts. That’s where Verana Health steps in. The team there curates deidentified IRIS Registry data so that physicians and researchers can easily access and filter the database to answer questions about quality scores and patient outcomes.

Because the IRIS Registry contains hundreds of millions of real-world patient encounters, ophthalmologists have a data-driven understanding of how practice patterns actually affect patients. Further, those in practice may be able to generate insights that would otherwise be beyond the scope of clinical trials.

Let’s take a concrete example. The anti-VEGF agent Beovu (brolucizumab, Novartis) was approved by the FDA in 2019 for the treatment of neovascular age-related macular degeneration. In 2020, reports surfaced of retinal vasculitis and/or retinal vascular occlusions, in the presence of intraocular inflammation, in post-marketing reports.

After Verana Health analyzed data from the IRIS Registry, it was determined that a history of intraocular inflammation and/or retinal vascular occlusions was associated with higher incidence of intraocular inflammatory and/or retinal vascular occlusion events in patients who received brolucizumab therapy for wet AMD in routine clinical practice. These data may be useful to both regulatory bodies (ie, FDA) and clinicians contemplating brolucizumab therapy for their patients — and are complementary to the safety data that were available in the phase 3 clinical trial reports.

Each month, I’ll update this blog with the latest findings from the IRIS Registry-Verana Health partnership. A wide range of diseases will be covered, and I’ll frequently collaborate with co-authors so that they can share their insights and expertise on particular topics.

We aren’t going to dive too deep into the data. This is a blog, after all, not a white paper. My goal is to give you a taste of the latest trends and let you decide if you want to research a topic further.

References:

• Baumal CR, et al. Ophthalmology. 2020;doi:10.1016/j.ophtha.2020.04.017.
• Ip MS, et al. The brolucizumab experience thus far: A health economics and outcomes research analysis. Presented at: American Academy of Ophthalmology annual meeting; Nov. 13-15, 2020 (virtual meeting).
• Novartis receives FDA approval for Beovu, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept. www.novartis.com/news/media-releases/novartis-receives-fda-approval-beovu-offering-wet-amd-patients-vision-gains-and-greater-fluid-reductions-vs-aflibercept. Published Oct. 8, 2019. Accessed April 21, 2021.
• Parke DW 2nd, et al. Ophthalmology. 2017;doi:10.1016/j.ophtha.2017.08.035.
• Zarbin M, et al. Profiles and early outcomes of patients who initiated brolucizumab for neovascular (wet) age-related macular degeneration (AMD) in the IRIS Registry and Komodo database. Presented at: American Academy of Ophthalmology annual meeting; Nov. 13-15, 2020 (virtual meeting).

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