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Thyroid Eye Disease (TED), also known as Rundle’s curve, is a debilitating, disfiguring, and potentially blinding disease. Muscles and fatty tissues behind the eye become inflamed. This pushes the eyes forward, causing them to bulge outwards (proptosis). Proptosis can cause a variety of symptoms such as eye pain, double vision, light sensitivity, or difficulty closing […]
Tepezza may cause hearing loss
Thyroid Eye Disease (TED), also known as Rundle’s curve, is a debilitating, disfiguring, and potentially blinding disease. Muscles and fatty tissues behind the eye become inflamed. This pushes the eyes forward, causing them to bulge outwards (proptosis). Proptosis can cause a variety of symptoms such as eye pain, double vision, light sensitivity, or difficulty closing the eye.
TED is a rare condition. TED occurs in about a quarter of people with thyroid dysfunction and nearly half of people with Grave’s disease. About 10% of people suffering from TED appear not to have Grave’s disease.
Tepezza, the brand name for teprotumumab, is an injectable prescription drug used to treat TED. Teprotumumab is a monoclonal antibody, intended to block the excessive immune response that causes the eye tissues to swell by targeting the insulin-like growth factor 1 receptor (IGF-1R).
Tepezza is currently available only as an intravenous (IV) infusion. Patients receive a series of infusions, typically over about five months. In November 2022, Horizon Therapeutics announced a research partnership and option agreement with Xeris Biopharma, to develop a ready-to-use, highly-concentrated, subcutaneous injection of teprotumumab.
Teprotumumab was first developed by Genmab as a potential cancer therapy, but multiple studies showed that it had little impact on prognosis. Narrow River Management founded Narrow Vision for the sole purpose of creating a TED drug. Horizon Therapeutics Ireland DAC acquired River Vision, creator of teprotumumab, in 2017.
The U.S. Food & Drug Administration (FDA) approved Tepezza for the treatment of TED on January 21, 2020. Tepezza was approved based on the results of two studies, including a combined total of 170 TED patients. All participants were adult patients with a Graves’ disease diagnosis and active thyroid eye disease. Half of the patients treated with teprotumumab in the studies showed significant improvements in proptosis at the 6-week point.
Tepezza, the only drug approved for TED treatment, was granted Priority Review, Fast Track, and Breakthrough Therapy Designation as well as an Orphan Drug designation. These programs provide incentives for the development of drugs for rare diseases or conditions. Horizon announced the start of Phase 4 clinical trial for Tepezza in September 2021.
Horizon announced that Tepezza sales in the first three quarters of 2022 were 37% higher than in 2021. The company indicated potential sales of $4 billion.
Common adverse events reported by teprotumumab users included muscle spasms (25%), nausea (17%), alopecia (13%), diarrhea (13%), fatigue (10%), hearing impairment (10%), and hyperglycemia (8%).
The use of Tepezza has more recently been linked to permanent hearing loss and/or tinnitus. In a study published in the American Journal of Ophthalmology in August 2022, 22 of 27 patients taking teprotumumab developed hearing damage symptoms after an average of 3.8 infusions. The study’s authors called for further study.
It is alleged that Horizon Therapeutics knew about the risks of hearing loss and tinnitus after several studies showed an association. Horizon Therapeutics listed hearing problems as an adverse reaction in February 2022, and mentioned “hearing impairment” in an October 13, 2022 press release.
Horizon, headquartered in Ireland, has operations in Dublin, Deerfield, IL, and Rockville, MD. Known as an investor in high-cost medications, including several orphan therapies, its mark. At its peak, Horizon was valued at over $27 billion. On November 29, 2022, Horizon Therapeutics stock rose 31% after the company revealed that it was engaged in preliminary acquisition talks with several of the largest pharmaceutical companies.
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