Market Spotlight: Thyroid Eye Disease (TED)
Market Spotlight: Thyroid Eye Disease (TED)
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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.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
- Description
- Contents
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 the annual incidence of TED in the general population is 16 per 100,000 in women and three per 100,000 in men.
- Based on these rates, Datamonitor Healthcare 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 Fc neonatal receptor. It is administered via the subcutaneous route.
- The only high-impact upcoming event in the TED space is top-line results from Tepezza’s Chronic TED trial. The overall likelihood of approval of a Phase I ophthalmology-other asset is 24.7%, and the average probability a drug advances from Phase III is 59.5%. 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 ongoing clinical trials for TED, with two trials.
- Horizon Therapeutics leads industry sponsors with the highest overall number of clinical trials for TED
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
8 Definition
8 Patient segmentation
10 Symptoms
10 Risk factors
11 Diagnosis
12 TREATMENT
12 Medical treatment
12 Orbital radiotherapy
12 Surgical treatment
14 EPIDEMIOLOGY
14 Thyroid eye disease occurrence in thyroid disorders
14 Incidence methodology
17 MARKETED DRUGS
19 PIPELINE DRUGS
23 RECENT EVENTS AND ANALYST OPINION
23 IMVT-1401 for Thyroid Eye Disease (March 30, 2020)
25 Tepezza for Thyroid Eye Disease (December 13, 2019)
26 Tepezza for Thyroid Eye Disease (December 11, 2019)
29 KEY UPCOMING EVENTS
30 KEY REGULATORY EVENTS
30 Horizon Sees Blockbuster Future For Tepezza After US Approval
31 PROBABILITY OF SUCCESS
32 LICENSING AND ASSET ACQUISITION DEALS
32 MiRagen Acquires Viridian In All-Stock Deal
33 REVENUE OPPORTUNITY
34 CLINICAL TRIAL LANDSCAPE
35 Sponsors by status
35 Sponsors by phase
36 Recent events
38 BIBLIOGRAPHY
38 Prescription information
39 APPENDIX
LIST OF FIGURES
16 Figure 1: Trends in incident cases of thyroid eye disease, 2020–29
19 Figure 2: Overview of pipeline drugs for thyroid eye disease in the US
19 Figure 3: Pipeline drugs for thyroid eye disease, by company
19 Figure 4: Pipeline drugs for thyroid eye disease, by drug type
20 Figure 5: Pipeline drugs for thyroid eye disease, by classification
25 Figure 6: IMVT-1401 for Thyroid Eye Disease (March 30, 2020): Phase IIa – ASCEND-GO 1
29 Figure 7: Key upcoming events in thyroid eye disease
31 Figure 8: Probability of success in the ophthalmology-other pipeline
34 Figure 9: Clinical trials in thyroid eye disease
34 Figure 10: Top 10 drugs for clinical trials in thyroid eye disease
35 Figure 11: Top 10 companies for clinical trials in thyroid eye disease
35 Figure 12: Thyroid eye disease trials status
36 Figure 13: Thyroid eye disease trials sponsors, by phase
LIST OF TABLES
14 Table 1: Prevalence of thyroid eye disease in Graves’ disease
15 Table 2: Incident cases of thyroid eye disease, 2020–29
18 Table 3: Marketed drugs for thyroid eye disease
21 Table 4: Pipeline drugs for thyroid eye disease in the US
23 Table 5: IMVT-1401 for Thyroid Eye Disease (March 30, 2020)
26 Table 6: Tepezza for Thyroid Eye Disease (December 13, 2019)
27 Table 7: Tepezza for Thyroid Eye Disease (December 11, 2019)
33 Table 8: Forecasted global sales, by drug ($m), 2021–25
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