ClinicalTepezza Sales Dip Slightly as Subcutaneous Formulation Shows Late-Stage...

Tepezza Sales Dip Slightly as Subcutaneous Formulation Shows Late-Stage Efficacy

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Sales of Amgen’s thyroid eye disease (TED) treatment Tepezza declined modestly in the fourth quarter of 2025, while new late-stage clinical data for a subcutaneous version of the drug indicated efficacy comparable to the currently approved intravenous formulation.

Tepezza generated $457 million in revenue during the fourth quarter, representing a 1% decrease from $460 million recorded in the same period in 2024. Despite the quarterly dip, full-year sales increased by 3%, reaching $1.9 billion compared to $1.85 billion the previous year. Analysts at Leerink Partners projected that global Tepezza sales could reach $2 billion this year.

New topline results showed that a subcutaneous version of Tepezza, delivered using Amgen’s on-body injector (OBI) technology, achieved a 76.7% proptosis response rate over 24 weeks. Proptosis, a defining symptom of TED, involves abnormal forward displacement of the eye. In comparison, the placebo group recorded a response rate of 19.6% over the same timeframe. According to Amgen, the difference between treatment and placebo was statistically significant and clinically meaningful.

The study also reported a reduction in proptosis of 3.17 mm in patients receiving subcutaneous Tepezza, compared to a 0.8 mm reduction in the placebo group. Additional secondary endpoints were met, including improvements in overall responder rate, diplopia (double vision), and quality of life.

Analysts at William Blair noted that the subcutaneous formulation demonstrated efficacy consistent with the intravenous version and described the results as encouraging. In an investor note, the firm stated, “We believe that the availability of the SC [subcutaneous] option could help the Tepezza franchise return to growth” in thyroid eye disease. Leerink Partners similarly indicated that the more convenient administration method could support increased adoption.

The emergence of subcutaneous treatment options is also being evaluated in the context of competing therapies. Viridian Therapeutics recently reported Phase 3 data for its TED candidate elegrobart, showing a 54% proptosis response rate with monthly dosing and 63% with dosing every eight weeks. The placebo group in that trial recorded an 18% response rate. William Blair noted that the placebo-adjusted efficacy fell below the 51% to 73% range that investors were expecting, and Viridian’s shares fell by more than 30% following the announcement.

William Blair analysts indicated that both elegrobart and subcutaneous Tepezza could usher in a new era for the TED space, noting that subcutaneous administration has the potential to expand the market, which has been stagnant over the past several quarters. The firm added that convenience will become a central consideration in the market.

At the same time, uncertainties remain regarding the use of Amgen’s on-body injector. Previous disclosures from European Union clinical trials indicated that doses would be administered by an investigator or trained designee, raising questions about whether patients could self-administer the treatment at home. Analysts noted that while efficacy will be the most important factor for medical decision-making, elegrobart “would likely offer greater convenience and fewer injections.”

No direct comparative studies between subcutaneous Tepezza and elegrobart have been conducted, and cross-trial comparisons remain inconclusive.

Tepezza Sales Show Minor Decline

Recent financial updates indicate that Tepezza sales have slightly declined, reflecting market saturation and increasing competition. Reports show that Tepezza revenue dipped by around 1% in late 2025, signaling a temporary slowdown in its growth trajectory.

Despite this dip, Tepezza remains a blockbuster therapy and a key revenue driver in the thyroid eye disease (TED) market.

Subcutaneous Tepezza Delivers Strong Phase 3 Results

In contrast to the sales slowdown, the subcutaneous version of Tepezza has delivered impressive results in a Phase 3 trial. The study met its primary endpoint, with approximately 77% of patients achieving a significant reduction in eye bulging (proptosis).

The recent dip in sales reflects broader shifts in the specialty pharma market rather than a fundamental weakness in the therapy itself. Pricing pressures, evolving reimbursement policies, and a natural plateau after rapid early adoption have all contributed to the slowdown. Many blockbuster drugs experience similar phases once initial demand is met and the eligible patient population stabilizes.

At the same time, physician prescribing behavior is evolving. Clinicians are increasingly weighing convenience, cost-effectiveness, and long-term patient adherence when selecting therapies. This is where the new formulation could significantly influence future uptake.

Patient Experience and Treatment Accessibility

One of the biggest limitations of infusion-based therapies has been the burden placed on patients. Regular hospital or clinic visits can be time-consuming, expensive, and logistically challenging—particularly for those living in remote areas.

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