A recent analysis of the American Academy of Ophthalmology (AAO) Intelligent Research in Sight (IRIS) Registry described the incidence of disease progression among patients with confirmed thyroid eye disease (TED) in real-world clinical practice.
This latest research was presented last week during the 2026 Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Denver, Colorado.
Give me some background on TED.
TED is a chronic autoimmune disease characterized by orbital tissue inflammation and tissue expansion that has traditionally been described as a self-limited, biphasic disease transitioning from an active inflammatory phase to a chronic, fibrotic phase.
However: Real-world evidence suggests a more heterogeneous and prolonged disease course and large-scale longitudinal data describing TED progression remain limited.
Now talk about the study.
In this Amgen Inc.-sponsored retrospective cohort study, investigators analyzed de-identified patient-level data from the IRIS Registry augmented with Komodo Health Research Dataset (KRD) claims data from Jan. 1, 2017 to Nov. 30, 2023.
The index date was the earliest of:
- Confirmed TED or Graves’ disease (GD) diagnosis in IRIS Registry
- TED eye signs/symptoms in IRIS Registry or KRD
- GD diagnosis from an ophthalmologist in KRD
Baseline demographics and comorbidities were described within the 12-month baseline period before the index date and TED severity was inferred from treatment or diagnoses in the ≥12-month follow-up period and categorized as follows:
- Untreated (mild)
- TED-related treatment (moderate-to-severe)
- Sight-threatening
Composite disease progression was defined as:
- The first occurrence of increased clinical activity score (CAS)
- Increased proptosis
- Worsening severity
- Treatment escalation
- New-onset of sight-threatening disease.
Talk about the study cohort.
In total 34,590 patients (76% female, 59% white, median age: 63 years) with TED were identified, of which:
- 92% likely had mild TED at diagnosis, though the comorbidity burden was substantial
- The median follow-up was 5 years in KRD
- Most patients had Medicare (48%) or commercial insurance (42%)
Common baseline comorbidities included:
- Hypertension (33%)
- Dry eye (20%)
- Type 2 diabetes (15%)
- Smoking (13%)
- Anxiety (11%)
And the results?
The analysis revealed that overall, 30% of patients experienced a composite progression event during follow-up.
Moreover: The cumulative incidence of first TED progression was estimated at:
- 1 year: 12%
- 2 years: 18%
- 5 years: 31%
- 8 years: 39%
Meaning: There was notable variability in TED progression timing across patients.
Limitations?
A few to note, including:
- This study was subject to limitations common to retrospective claims analyses, including coding errors, missing data, and incomplete clinical documentation
- Although linked IRIS Registry–KH claims data provide a more comprehensive view than either source alone, underreporting of conditions or treatments remains possible
- TED diagnosis date was defined by first mention in clinical notes and may not reflect true disease onset, particularly for cases prior to IRIS availability (i.e., pre-2016)
- Treatment escalation was used as a proxy for disease progression and may introduce misclassification; however, treatment-inferred progression, which was available for the full sample, reinforced the composite progression trends observed
Take home.
This large, real-world cohort of confirmed TED patients demonstrated substantial and heterogeneous disease burden, including thyroid dysfunction.
Disease progression occurred well beyond the early disease period, reinforcing the chronic nature of TED, wherein some patients experienced rapid progression, while others progressed years later.
These findings challenge the traditional, self-limited paradigm of TED and highlight the need for ongoing monitoring and reassessment of management strategies.
Any recent news about TED that I should keep an eye on?
Indeed. There has been a lot of movement in the FDA pipeline around TED, for example:
- In April 2026: Amgen released positive topline findings from a phase 3 trial evaluating TEPEZZA (teprotumumab-trbw) administered via subcutaneous injection (instead of intravenous fluid) for the treatment of moderate to severe TED
- In March 2026: Viridian Therapeutics reported positive topline data from the phase 3 REVEAL-1 trial and anticipates submitting a BLA for ELEGROBART in Q1 2027
- In January 2026: Viridian announced that the FDA accepted the BLA for VELIGROTUG with a PDUFA date of June 20, 2026
Plus: LINSITINIB is currently under investigation by Sling Therapeutics in the ongoing phase 2b LIDS trial.
As always, stay tuned for more updates!