Teprotumumab-TRBW

Some six years after scoring an initial FDA nod in neuromyelitis optica spectrum disorder, Roche’s IL-6 receptor inhibitor Enspryng is muscling up to Amgen's Tepezza in a key eye disease arena. The FDA late this week endorsed Enspryng, also known as satralizumab, as a new treatment option for adults living with thyroid eye disease (TED), an autoimmune condition that can lead to swelling and bulging of the eyes, vision problems and pain. The drug is delivered via below-the-skin injection, which can be done by the patient themselves or a caregiver from the comfort of home, according to an Oct. 16 release from Roche’s Genentech unit. A rare condition, TED is estimated to affect roughly 155 out of every 100,000 people in the United States, introducing the risk of facial disfigurement and potential vision-complications if left untreated, Roche said. Beyond the steroids used to control swelling in TED patients, the current treatment landscape is dominated by Amgen’s IGF-1R inhibitor Tepezza—which generated $1.9 billion in 2025 sales—while Viridian Therapeutics just snared a green light for its own TED challenger in similarly classed Lumvoa back in June. Bringing a new mechanism to the table, meanwhile, Enspryng was formulated to bind both soluble and membrane-bound interleukin-6 receptors, in turn inhibiting the IL-6 mediated signaling that Roche has flagged as a key inflammation pathway. The drug’s original 2020 nod in neuromyelitis optica spectrum disorder (NMSOD)—a rare and potentially devastating autoimmune condition that can cause blindness, paralysis and nerve pain—was a first for the IL-6 receptor inhibitor class as well. Roche relied on results from its phase 3 SatraGO program to secure the new TED approval, though Enspryng’s performance across the pair of trials involved was somewhat mixed, with the SatraGO-1 study failing to meet its pre-specified primary efficacy endpoint at the 24-week mark. The drug fared better in SatraGO-2, in which 52.9% of patients who got Enspryng achieved a significant and clinically meaningful difference in proptosis response—referring to the bulging of one or both eyes—compared to 23.4% of those who received placebo. For the reduction of diplopia, or double vision, in SatraGo-2, Enspryng helped chart meaningful improvements in over 60% of patients, versus a score of 25.8% in the trial’s control arm. Those results drew from the study’s active TED population, with Roche noting in its release that the readout in the overall population, which included both active and chronic patients, was “consistent.” “Today’s FDA approval of Enspryng provides an important new option for people with thyroid eye disease, who have long faced limited treatment choices,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and product development chief, in a statement. Apart from bringing a new mechanism of action to bear, Enspryng’s self-injection option could carry a serious convenience edge over Tepezza and Lumvoa, both of which are given via infusion. With Viridian’s Lumvoa approval earlier this summer, the company highlighted the fact that its approval applied to adults with active or chronic TED, making it the first IGF-1R inhibitor cleared in both forms of the disease—a potential advantage over Tepezza. The company also spotlighted the shorter infusion time on Lumvoa—at 30 to 40 minutes versus around an hour on Tepezza—plus a shorter overall treatment period of 12 weeks, too. Meanwhile, adherence and convenience appeared top of mind at the FDA this week, as the U.S. regulator also handed down an approval for a new autoinjector format of UCB’s C5 inhibitor for generalized myasthenia gravis (gMG), Zilbrysq. As in the case of Enspryng, UCB’s subcutaneous Zilbrysq formulation can be received beyond the confines of the doctor’s office or infusion clinic. The new nod marks the second for a self-administration option for Zilbrysq, which was first approved by the FDA for gMG in Oct. 2023, and which also comes in the form of a pre-filled syringe that can be used on one’s own. UCB says it expects to launch its autoinjector in 2027’s first quarter. With the thumbs up, UCB figures it now has the answer to “a question on which we've been relentlessly focused: How do we continue to improve an already effective therapy for daily use?" said Kimberly Moran, Ph.D., SVP and head of rare diseases for the U.S. at UCB, in a statement.

LOS ANGELES, Oct. 12, 2026 /PRNewswire/ -- Raymond Douglas, MD, PhD, a lead scientist behind the first FDA-approved treatment for thyroid eye disease (TED) and a 2026 ASOPRS Outstanding Contribution Award recipient, presented research at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) 57th Annual Fall Scientific Symposium pointing to a new dosing approach for the patients most at risk of hearing side effects. The study found that spacing teprotumumab infusions six weeks apart, rather than the standard three, may protect hearing in TED patients who already have hearing loss, without giving up the benefits of treatment. The symposium took place October 8–9, 2026, at the Hyatt Regency New Orleans. Teprotumumab (TEPEZZA®) is the first FDA-approved medicine for TED, an autoimmune condition that can cause eye bulging, inflammation, double vision, and changes in appearance. The FDA-approved regimen is eight infusions given three weeks apart. Hearing-related side effects have been reported in about 10% of patients in the phase 2 and phase 3 clinical trials, and in as many as 50% of "high-risk" patients who have hearing problems before treatment begins. There has been no established protocol designed specifically for TED patients with existing hearing loss. To help close that gap, Dr. Douglas and his team studied whether a longer interval between infusions could better protect these patients' hearing. The longer interval made a measurable difference. Patients on a six-week schedule were more than 60% less likely to experience a decline in their hearing. At 24 weeks, nearly half of patients on the standard three-week schedule (45%, 9 of 20) showed a clinically significant decline on formal audiometry, compared with about one in six on the six-week schedule. Importantly, the longer interval did not appear to reduce the effectiveness of treatment. The two groups showed no significant differences in improvement in inflammation, eye bulging, or double vision. "When we began studying the biology of thyroid eye disease decades ago, there was no approved treatment to offer patients. Today teprotumumab has changed what's possible for them, and our work isn't finished," said Dr. Raymond Douglas. "Patients who already live with hearing loss have told us this side effect is their greatest concern. These results suggest that for this higher-risk group, spacing infusions further apart may help protect hearing without giving up the benefits of treatment. It is humbling to keep finding ways to make these therapies better and safer for the patients who trust us with their care. This work is also an important reminder to monitor hearing and other potential side effects closely, before and throughout treatment." Additionally, Dr. Douglas and longtime collaborator Terry J. Smith, MD, were presented with this year's ASOPRS Outstanding Contribution Award for their years of research on thyroid eye disease. The award recognizes members whose project-based work makes a significant contribution to the Society or the field, beyond service and committee work. Dr. Douglas began his TED research during his fellowship at UCLA under Drs. Robert Goldberg and Terry Smith, launching more than two decades of work on the IGF-1R pathway that contributed to the development of teprotumumab. About the Study Dr. Douglas and his team reviewed 38 consecutive TED patients treated with teprotumumab, all of whom had hearing loss confirmed by formal audiometry before their first infusion. Patients with existing hearing loss were offered the option of the six-week schedule, resulting in two groups similar in age and sex: Six-week schedule: 18 patients (13 women, 5 men; average age 57) Standard three-week schedule: 20 patients (16 women, 4 men; average age 57) Each patient's hearing was tested with audiometry, the gold standard for measuring hearing, before treatment and again at 24 weeks. A clinically significant change was defined using American Speech-Language-Hearing Association (ASHA) criteria. The team also tracked whether treatment remained effective by measuring inflammation, eye bulging, and double vision. The findings add to growing evidence that hearing should be tested before teprotumumab begins and monitored throughout treatment, and they point to a longer infusion interval as a promising option for patients at higher risk. Because this was a retrospective study of a relatively small group, the researchers note that larger prospective studies are needed to confirm the results. Presentation Details Title: Extended 6-Week Teprotumumab Interval Reduces Audiometric Deterioration Compared to a Standard 3-Week Interval Schedule Presenting Author: Shoaib Ugradar, MD Authors: Raymond S Douglas, MD, PhD, Shoaib Ugradar, MD, Anthony Wong, MD, Pershanjit Raika, MBBS, Raymond N Douglas, Tasmin Sazzad, Madison Chan Meeting: ASOPRS 57th Annual Fall Scientific Symposium Date/Time: October 8-9, 2026 Location: Hyatt Regency New Orleans, New Orleans, Louisiana About Raymond Douglas, MD, PhD Raymond Douglas, MD, PhD, is a board-certified oculoplastic surgeon and internationally recognized thyroid eye disease specialist based in Beverly Hills, California, with practices in Southern California and Las Vegas. He was one of the lead scientists in the development of teprotumumab and served as principal investigator of the international clinical trials that led to its FDA approval, and he was the first physician in the world to treat patients with the medicine after approval. Dr. Douglas earned his medical degree and a doctorate in immunology from the University of Pennsylvania and completed fellowship training in orbitofacial plastic and reconstructive surgery at the UCLA Stein Eye Institute. Learn more at raymonddouglasmd.com. References Smith TJ, et al. Teprotumumab for Thyroid-Associated Ophthalmopathy. N Engl J Med. 2017;376(18):1748-1761. doi:10.1056/NEJMoa1614949 Douglas RS, et al. Teprotumumab for the Treatment of Active Thyroid Eye Disease. N Engl J Med. 2020;382(4):341-352. doi:10.1056/NEJMoa1910434 Keen JA, et al. Frequency and Patterns of Hearing Dysfunction in Patients Treated with Teprotumumab. Ophthalmology. 2024;131(1):30-36. doi:10.1016/j.ophtha.2023.08.001 TEPEZZA® is a registered trademark of its owner. This research was not presented as an endorsement of any change to the FDA-approved dosing schedule. Patients should not change their treatment schedule on their own. Anyone receiving or considering teprotumumab should talk with their physician about hearing monitoring and the dosing approach that is right for them. Media Contact Morgan Douglas / Marketing Director 248-767-8444 / [email protected] SOURCE Dr. Raymond Douglas, MD, PhD 21% more press release views with Request a Demo