New Biologic Sharply Reduces Need for Orbital Decompression Surgery

Orbital decompression surgery, long a cornerstone treatment for thyroid eye disease, has declined significantly since the Food and Drug Administration's 2020 approval of the biologic teprotumumab, according to a Houston Methodist-led national analysis.

The findings, published in International Forum of Allergy & Rhinology in April, provide the clearest population-level evidence to date that the medical therapy is reshaping care patterns for the disfiguring and potentially vision-threatening autoimmune condition.

"We saw that decompression volumes were going down in our clinics and wanted to know if that was happening nationally and at a meaningful scale," said senior author Dr. Omar Ahmed, an otolaryngologist at Houston Methodist. "This biologic has changed the landscape. We're still early in its use, but the trend is clear: We're relying less on surgery because we finally have a medical therapy that works."

Using the TriNetX database, researchers evaluated more than 16,000 adults with thyroid eye disease and found that patients treated after teprotumumab's approval were nearly half as likely to undergo orbital decompression surgery as those treated in prior years (relative risk 0.56). Before 2020, annual surgical incidence rose steadily, peaking at 2.28%. After biologic therapy became available, that rate fell to 1.54%.

To ensure the decrease wasn't simply an artifact of the pandemic's impact on elective procedures, the team compared orbital decompression rates to cataract surgery volumes over the same period. Cataract surgeries dipped briefly in 2020 but quickly rebounded — a contrast to the continued decline in decompressions.

Teprotumumab, the first FDA-approved therapy for thyroid eye disease, works by blocking an inflammatory signaling pathway that drives tissue expansion behind the eye.

Dr. Ahmed noted that while the drug's mechanism of action differs markedly from surgery, the clinical effect — reduced swelling and proptosis — is often the same. "Instead of creating more space surgically, the medicine prevents the tissue from enlarging in the first place," Dr. Ahmed explained.

Although the medication has impacted surgical volume, the procedure is still far from obsolete.

"The study shows volumes have declined, but there is still a real and important role for decompression," said Dr. Amina Malik, an ophthalmic plastic surgeon at Houston Methodist and one of the study's co-authors. "Some patients don't respond to the drug, some have contraindications, and others may still prefer a one-time surgical solution."

Certain patients — including those presenting with compressive or stretch-related optic neuropathy — may require urgent surgical intervention to prevent permanent vision loss.

"Tepezza is not currently approved for optic neuropathy, and while we sometimes see a benefit in using it in these patients, they often require surgery urgently in order to prevent vision loss," Dr. Malik said.

The authors note that long-term durability, cost-effectiveness and the optimal medical-surgical sequencing strategy remain important unanswered questions. Still, the shift towards medical therapy represents a major milestone for a disease that affects up to half of patients with Graves' disease.

"Having both medical and surgical options is always better for patients," Dr. Malik said. "This is an exciting time — one where individualized, multidisciplinary care matters more than ever."