Tepezza® — Teprotumumab Infusion

For Active Thyroid Eye Disease

Tepezza (teprotumumab-trbw) is the first FDA-approved medical therapy specifically targeting the underlying pathology of Thyroid Eye Disease. In clinical trials, it reduced proptosis (bulging eyes) in over 80% of patients — without surgery — and significantly improved double vision, lid retraction, and quality of life.

What Is Tepezza?

Tepezza (generic name: teprotumumab) is a fully human monoclonal antibody approved by the FDA in January 2020 for the treatment of active Thyroid Eye Disease (TED), also called Graves' ophthalmopathy. It is administered as an intravenous (IV) infusion in an outpatient infusion center or physician's office.

Before Tepezza, the only options for significant proptosis were IV steroids — which provided temporary relief — or surgical orbital decompression. Tepezza targets the disease mechanism directly, producing durable reductions in proptosis and inflammation that persist well beyond the completion of the treatment course.

Dr. Brown has managed thyroid eye disease for over 20 years and incorporates Tepezza into a comprehensive TED care plan that includes endocrinology co-management, surgical backup for decompression, strabismus correction, and eyelid procedures.

How It Works

The hallmark of TED is activation of orbital fibroblasts — connective tissue cells within the orbit — by two key immune receptors: the thyroid-stimulating hormone receptor (TSHR) and the insulin-like growth factor-1 receptor (IGF-1R). When autoantibodies bind these receptors, fibroblasts proliferate, produce excess hyaluronic acid, and differentiate into fat cells, causing orbital volume to expand. The result is proptosis, lid retraction, double vision, and orbital pain.

Teprotumumab's Target: IGF-1R

Teprotumumab binds and blocks the IGF-1R receptor, interrupting the signal cascade that drives fibroblast activation. By silencing this pathway, the drug:

  • Reduces hyaluronic acid production, decreasing orbital soft tissue volume
  • Decreases proptosis — the forward protrusion of the eye
  • Reduces orbital fat and extraocular muscle enlargement
  • Improves lid retraction (upper and lower eyelid position)
  • Reduces diplopia (double vision) from restrictive strabismus
  • Decreases Clinical Activity Score (CAS) — the marker of active inflammation

Because teprotumumab acts on a different pathway than steroids, patients who have failed or cannot tolerate steroid therapy may still respond to Tepezza.

Clinical Trial Results

Tepezza was approved on the basis of two randomized, double-blind, placebo-controlled trials (OPTIC and its predecessor). Key results at the end of treatment (week 24):

OutcomeTepezzaPlacebo
Proptosis response (≥2 mm reduction)83%10%
Overall response rate78%7%
Mean proptosis reduction2.82 mm0.54 mm
Clinical Activity Score response59%21%
Diplopia response68%29%
Quality of life (GO-QOL)+19.0 pts+6.6 pts

OPTIC Extension — Durability

In the OPTIC extension study, patients who responded to Tepezza maintained significant proptosis reductions at 51 weeks post-treatment, with most responders sustaining their improvements. Patients who relapsed after initial treatment responded well to a second course of teprotumumab.

Who Qualifies?

Tepezza is most effective in patients with active thyroid eye disease — meaning the inflammatory phase of TED is ongoing. Key candidacy criteria:

Active inflammation

Clinical Activity Score (CAS) of 4 or higher out of 7. Symptoms include pain with eye movement, redness, swelling, and conjunctival injection.

Recent onset

Ideally within the first 9–12 months of symptom onset, when the inflammatory phase is most active and treatment response is highest.

Significant proptosis or diplopia

Proptosis ≥3 mm above normal, or new or worsening diplopia that impacts daily function.

Controlled thyroid function

Thyroid hormone levels should be stabilized with endocrinology management before or concurrent with Tepezza treatment.

Note on inactive TED: Patients in the inactive (quiescent) phase of TED — stable proptosis, no active inflammation — are not candidates for Tepezza and should be evaluated for surgical options including orbital decompression, strabismus surgery, and eyelid recession.

Treatment Protocol

Tepezza is administered as an IV infusion according to a standardized protocol:

Infusion 1

10 mg/kg over 90 minutes. Baseline eye measurements, Clinical Activity Score, and blood glucose are recorded before starting.

Infusions 2–8

20 mg/kg every 3 weeks. Each subsequent infusion may be shortened to 60 minutes if infusion 1 was well tolerated. Total treatment: 24 weeks.

Between infusions

Eye exams and Hertel exophthalmometry at each visit track proptosis reduction. Blood glucose monitoring is recommended, especially in patients with diabetes or pre-diabetes.

After infusion 8

Final measurements at week 24. Most patients reach maximum response by infusion 6–8. Stable disease can then be monitored; relapse is treated with a second course.

Insurance coverage: Tepezza is FDA-approved and covered by most commercial insurance plans and Medicare Part B when medical necessity criteria are met (active TED, CAS ≥ 4). Prior authorization is typically required. Our team assists with the authorization process.

Side Effects & Monitoring

Tepezza is generally well tolerated. Most patients complete all 8 infusions without significant interruption. The most clinically important side effects to monitor:

Hyperglycemia (elevated blood glucose)

Common

Blood glucose can rise significantly during and after infusions. Patients with diabetes or pre-diabetes require close monitoring. Dosing interruption may be needed. All patients should have fasting glucose checked before each infusion.

Hearing changes / tinnitus

Uncommon (up to ~65% in some reports)

Hearing loss, tinnitus, and autophony (hearing own voice abnormally loud) have been reported — some cases permanent. Audiologic baseline and monitoring is recommended, especially in patients with pre-existing hearing issues.

Muscle cramps

Common (~25%)

Usually mild and manageable with magnesium supplementation. Rarely requires treatment interruption.

Hair thinning (alopecia)

Common (~15%)

Diffuse thinning usually resolves after completing the treatment course.

Infusion reactions

Uncommon (~4%)

Mild reactions (flushing, headache, nausea) can usually be managed with slowing the infusion rate. Severe reactions are rare.

Inflammatory bowel disease exacerbation

Rare

Tepezza is contraindicated in patients with active IBD. Patients with known IBD should discuss this risk carefully.

Why an Oculoplastic Surgeon for TED Care?

TED is a complex, multi-stage disease that requires monitoring and management across its entire natural history — from the inflammatory phase treated with Tepezza, through the stable phase where surgical rehabilitation is performed. An oculoplastic surgeon is uniquely positioned to provide this continuity:

  • Complete orbital expertise

    Dr. Brown is ASOPRS fellowship-trained — the subspecialty credentialing body for orbital and eyelid surgery. He measures proptosis, grades CAS, and interprets orbital imaging to track disease response to Tepezza over time.

  • Surgical backup when needed

    When Tepezza produces a plateau — or when disease is inactive — Dr. Brown performs orbital decompression, strabismus surgery, and eyelid recession in-house. Patients don't need to restart care with a new provider.

  • Only ASOPRS surgeon on the Eastern Shore

    Dr. Brown is the only ASOPRS-fellowship-trained oculoplastic surgeon performing orbital surgery in Baldwin County, serving the Eastern Shore, Gulf Shores, and Pensacola areas.

  • Endocrinology co-management

    TED is driven by underlying thyroid autoimmunity. Dr. Brown coordinates care with your endocrinologist, and our team assists with the prior authorization process for Tepezza infusions.

Schedule a TED / Tepezza Consultation

Dr. Brown evaluates patients with thyroid eye disease at our Mobile and Daphne offices. Call or request an appointment online to discuss Tepezza candidacy, orbital monitoring, and complete TED care.