Market Spotlight: Thyroid Eye Disease (TED)

Thyroid eye disease (TED), also called Graves’ ophthalmopathy or orbitopathy, is an autoimmune disorder that causes inflammation in the orbital and retroocular tissues. It generally occurs as a manifestation of Graves’ disease, a condition in which the immune system attacks the thyroid gland, commonly affecting the eyes and skin. Although TED is usually found in Graves’ hyperthyroidism patients, some patients may have autoimmune euthyroid or hypothyroid thyroiditis. TED is mostly a mild, non-progressive, and self-limiting disease; however, in rare cases it can progress to vision loss. The negative impact of TED on the social and psychological well-being of individuals is an established consequence of the disease.

Key Takeaways

Thyroid eye disease (TED) is associated with thyroid disease, and most commonly occurs in Graves’ disease, where it is estimated to be present in ~40% of patients.
Epidemiological data are limited for TED, but it is reported in the literature that annual incidence in the general population is 16 per 100,000 in women and three per 100,000 in men.
Based on these rates, the publisher estimates that in 2020, there were 384,000 incident cases of TED worldwide, and expects that number to increase to 438,000 incident cases by 2029.
The only approved drug in the TED space is Horizon’s Tepezza, which targets insulin-like growth factor-1 receptor. It is currently available as an intravenous formulation.
The only industry-sponsored drug in active clinical development for TED is in Phase II.
The only drug in development for TED targets the neonatal Fc receptor. It is administered via the subcutaneous route.
The only high-impact upcoming event in the TED space is topline results from Tepezza’s Chronic TED trial. The overall likelihood of approval of a Phase I ophthalmology-other asset is 22.8%, and the average probability a drug advances from Phase III is 55%. Drugs, on average, take 8.6 years from Phase I to approval, compared to 8.9 years in the overall ophthalmology space.
Clinical trials for TED are equally distributed between the mid and late phases of development.
Horizon Therapeutics has the highest number of completed clinical trials for TED, with three trials.
Horizon Therapeutics leads industry sponsors with the highest overall number of clinical trials for TED

OVERVIEWKEY TAKEAWAYS

DISEASE BACKGROUND

Definition
Patient segmentation
Symptoms
Risk factors
Diagnosis

TREATMENT

Medical treatment
Orbital radiotherapy
Surgical treatment

EPIDEMIOLOGY

Thyroid eye disease occurrence in thyroid disorders
Incidence methodology

MARKETED DRUGSPIPELINE DRUGS

RECENT EVENTS AND ANALYST OPINION

Batoclimab for Thyroid Eye Disease (March 30, 2020)
Tepezza for Thyroid Eye Disease (December 13, 2019)
Tepezza for Thyroid Eye Disease (December 11, 2019)

KEY UPCOMING EVENTS

KEY REGULATORY EVENTS

With Return Of Tepezza Supply, Horizon Is Ready To Get Back To Business

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

MiRagen Acquires Viridian In All-Stock Deal

REVENUE OPPORTUNITY

CLINICAL TRIAL LANDSCAPE

Sponsors by status
Sponsors by phase

BIBLIOGRAPHYAPPENDIX

LIST OF FIGURES

Figure 1: Trends in incident cases of thyroid eye disease, 2020–29
Figure 2: Overview of pipeline drugs for thyroid eye disease in the US
Figure 3: Pipeline drugs for thyroid eye disease, by company
Figure 4: Pipeline drugs for thyroid eye disease, by drug type
Figure 5: Pipeline drugs for thyroid eye disease, by classification
Figure 6: Batoclimab for Thyroid Eye Disease (March 30, 2020): Phase IIa - ASCEND-GO 1
Figure 7: Key upcoming events in thyroid eye disease
Figure 8: Probability of success in the ophthalmology-other pipeline
Figure 9: Clinical trials in thyroid eye disease
Figure 10: Top 10 drugs for clinical trials in thyroid eye disease
Figure 11: Top 10 companies for clinical trials in thyroid eye disease
Figure 12: Thyroid eye disease trials status
Figure 13: Thyroid eye disease trials sponsors, by phase

LIST OF TABLES

Table 1: Prevalence of thyroid eye disease in Graves’ disease
Table 2: Incident cases of thyroid eye disease, 2020–29
Table 3: Marketed drugs for thyroid eye disease
Table 4: Pipeline drugs for thyroid eye disease in the US
Table 5: Batoclimab for Thyroid Eye Disease (March 30, 2020)
Table 6: Tepezza for Thyroid Eye Disease (December 13, 2019)
Table 7: Tepezza for Thyroid Eye Disease (December 11, 2019)
Table 8: Historical global sales, by drug ($m), 2016–20
Table 9: Forecasted global sales, by drug ($m), 2021–25

Table of Contents

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