FDA Panel Recommends Approval of a New Treatment for Graves’ Ophthalmopathy

According to a story from Medscape, an advisory panel from the US Food and Drug Administration (FDA) has recommended the approval of the drug teprotumumab for intravenous administration as a treatment for Graves’ ophthalmopathy, a rare autoimmune disease that can cause vision loss in severe cases. If approved, teprotumumab would be the very first therapy ever approved for this disease.

About Graves’ Ophthalmopathy

Graves’ ophthalmopathy, which is also called thyroid eye disease, is a rare, inflammatory disorder that affects the orbital and periorbital tissues around the eye. People with this condition often have eyes that are abnormally bulged in appearance. It is an autoimmune disease, meaning that it is triggered by an abnormal immune response in which the system mistakenly attacks healthy tissue. While most common in people with Graves’ disease, the condition can appear alongside a variety of conditions that affect the thyroid. Women are more likely to be affected than men. Symptoms include conjunctivitis, retracted upper eyelids, swelling, eye redness, lid lag, and bulging eyes. Though some cases are mild and resolve on their own, more serious cases constitute a medical emergency due to compression of the optic nerve and should be treated promptly. Treatment includes steroids and other medication to bring down inflammation, surgery, and medications to regulate thyroid hormones. To learn more about Graves’ ophthalmopathy, click here.

Improving The Lives of Patients

The reality is that there is a real need for more effective therapies for this disease. The illness can have significant and debilitating effects on patients both physically and emotionally by preventing them from conducting regular daily activities like driving, reading, socializing, or sleeping. The specific committee that recommended the approval was the Dermatologic and Ophthalmic Drugs Advisory Committee; all twelve members voted in favor of approval.

The recommendation follows positive performance of teprotumumab in the clinical trial setting. The drug was able to decisively improve proptosis (eye bulging) when compared to placebo. The drug has previously earned Fast Track designation (April 2015), Breakthrough Therapy designation (July 2016), and Orphan Drug designation (June 2019).

Overall, it seems like patients with Graves’ ophthalmopathy will hopefully have a new treatment available to them in the not too distant future.


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