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Amgen Reports Strong Phase 3 Results for New Tepezza Delivery Method in Thyroid Eye Disease

Eyewire+5h ago2 min read

Amgen announced promising results from a phase 3 clinical trial evaluating a new subcutaneous delivery method for its blockbuster drug Tepezza (teprotumumab-trbw), offering potential improvements in convenience for patients with Thyroid Eye Disease (TED). The study tested Tepezza administered via an on-body injector (OBI), a wearable device designed to deliver the drug under the skin rather than through traditional intravenous (IV) infusion. According to the company, the subcutaneous version demonstrated efficacy comparable to the IV formulation, which is currently the only approved treatment for TED and has been used by more than 25,000 patients worldwide. The trial met its primary endpoint, showing a 77% proptosis response rate—a key measure of eye bulging reduction—among patients receiving Tepezza OBI over a 24-week period, compared to just 19.6% in the placebo group. The results were statistically significant and clinically meaningful. Patients treated with the OBI version also experienced an average reduction in eye protrusion of 3.17 mm, exceeding the 0.80 mm reduction seen with placebo. Beyond the primary endpoint, the study reported improvements across multiple secondary measures, including: Overall response rates Reduction in disease activity scores Improvements in double vision (diplopia) Enhanced quality of life related to appearance According to Amgen, the new delivery method could make treatment more accessible. Unlike IV infusions that require clinic visits, the on-body injector allows for subcutaneous administration, potentially enabling more flexible treatment settings. “This advancement opens the possibility of a more accessible experience for patients,” said Dr. Madhura Tamhankar of the University of Pennsylvania. “Achieving comparable efficacy to IV therapy makes this especially compelling.” The safety findings aligned with Tepezza's known profile. The most common side effects included muscle spasms, tinnitus, nausea, and diarrhea. Some patients experienced mild-to-moderate injection site reactions, but these did not lead to treatment discontinuation. Amgen said it plans to present full results from the trial at an upcoming medical conference and may pursue regulatory pathways to expand Tepezza’s approved use to include the subcutaneous delivery method.

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AI Summary

Quick Take

Amgen’s Phase 3 trial of a subcutaneous on-body injector for Tepezza (teprotumumab-trbw) met its primary endpoint, achieving a 77% proptosis response rate compared to 19.6% for placebo. The wearable delivery system demonstrated a 3.17 mm reduction in eye protrusion over 24 weeks, suggesting the subcutaneous route offers comparable efficacy to the established intravenous formulation.

Why It Matters

While Tepezza is the standard of care for Thyroid Eye Disease, the current requirement for intravenous infusions creates logistical hurdles for both patients and practices, often requiring specialized infusion centers and significant chair time. A subcutaneous on-body injector could decentralize TED treatment, allowing for administration in more flexible clinical settings and improving patient convenience. This development is a significant step in evolving the delivery of biologic therapies in eyecare, potentially increasing treatment adherence for a condition that significantly impacts quality of life and appearance.

Key Findings

The trial achieved a 77% proptosis response rate in the subcutaneous group at 24 weeks, significantly higher than the 19.6% observed in the placebo group.
Patients using the on-body injector experienced a mean reduction in eye bulging of 3.17 mm, compared to a 0.80 mm reduction for those on placebo.
Secondary endpoints, including improvements in diplopia (double vision), disease activity scores, and appearance-related quality of life, were all significantly met.
The safety profile of the subcutaneous delivery was consistent with the known IV profile, with common adverse events including muscle spasms, tinnitus, nausea, and diarrhea.
Injection site reactions were reported as mild-to-moderate and did not result in any patients discontinuing the treatment.

Study Snapshot

Design

Phase 3 clinical trial

Population

Patients with Thyroid Eye Disease (TED)

Practice Implications

Clinicians may soon have a more streamlined delivery option for TED that bypasses the need for traditional IV setups, which could simplify the referral and treatment pipeline. If approved, the on-body injector may be particularly beneficial for patients with poor venous access or those who face geographic barriers to infusion centers, though monitoring for known side effects like tinnitus and muscle spasms remains essential.

Who's Affected

Oculoplastic SurgeonsNeuro-ophthalmologistsComprehensive OphthalmologistsOptometristsPractice Owners

What's Next

Amgen plans to present the full Phase 3 data at a future medical conference. Following this, the company is expected to pursue regulatory pathways to expand Tepezza’s labeling to include this subcutaneous delivery method.

Evidence StrengthStrong

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