On June 26, 2026, the FDA approved veligrotug-vvze (Lumvoa; Viridian Therapeutics) for the treatment of thyroid eye disease (TED), regardless of disease activity or duration.^1,2 The approval was supported by results from two pivotal phase 3 trials—THRIVE, which enrolled patients with active TED, and THRIVE-2, which enrolled patients with chronic TED—both of which met their primary and all secondary end points at week 15.¹ Patients in both trials received 5 IV infusions administered every 3 weeks over a 12-week course, with proptosis reductions observed as early as week 3.¹ Veligrotug is the first approved therapy in the IGF-1R inhibitor class to carry labeling that includes data from both active and chronic TED, according to the company.¹ The approval expands the armamentarium of FDA-approved therapies for TED, joining teprotumumab (Tepezza; Amgen), which was approved in 2020 and recently reported positive phase 3 results for a subcutaneous formulation.³

To explore what the veligrotug approval means for patients and practice, Ophthalmology Times posed the same questions to several TED specialists, including the following:

• Raymond S. Douglas, MD, PhD, TED specialist and oculoplastic surgeon practicing in Beverly Hills, California, and professor of surgery in the Division of Ophthalmology at Cedars-Sinai in the Los Angeles metropolitan area.
• Steven Leibowitz, MD, clinical professor of ophthalmology, Stein Eye Institute, Geffen School of Medicine, University of California Los Angeles (UCLA), and principal investigator for Viridian's TED clinical trials.
• Jennifer Murdock, MD, oculofacial cosmetic and reconstructive surgeon practicing in Miami, Florida, with expertise in TED, eyelid and orbital reconstruction, and minimally invasive cosmetic injectables.

Their responses appear below in alphabetical order.

Note: Edited lightly for clarity and length.

The Phase 3 program demonstrated robust efficacy with a five-infusion regimen over 12 weeks. How meaningful is this shorter treatment course from both a patient and practice perspective?

Raymond S. Douglas MD, PhD: From a patient perspective, compressing a course of therapy that previously required 8 infusions over roughly 24 weeks into a 3‑month regimen is extremely meaningful, because it reduces the time [that] they spend organizing their lives around infusion visits and allows them to return to work and daily activities sooner.

For practices, a shorter course with fewer infusions opens up infusion‑chair capacity, which is particularly important in busy centers that are already balancing other biologic infusions.

Steven Leibowitz, MD: Treatment burden is a very real consideration for patients with TED. Veligrotug's regimen, which is 5 infusions over 12 weeks, represents a meaningful reduction compared with the 8 infusions over 21 weeks required with the currently available treatment. For patients who are managing work, family, and the emotional toll of this disease, getting rapid relief from symptoms and completing a course of therapy as quickly and efficiently as possible allows them to get back to their lives sooner.

Jennifer Murdock, MD: A shorter treatment course is very meaningful from both a patient and practice standpoint. When safety and efficacy are comparable, patients will generally prefer a 12-week regimen over a longer 21-week course. It is more convenient, less disruptive to work and life, and easier to complete.

Durability is still something we will better understand over the next several years, but the shorter course may be especially appealing for patients who are planning a family. Given the known teratogenic risk with IGF-1 pathway inhibitors, patients need to follow strict contraception during treatment and for a period of time afterward. I have had several patients with TED who were hoping to start or expand their families, so the ability to control inflammatory disease over a shorter period of time and then move forward with that next stage of life could be a meaningful advantage with veligrotug.

Where do you see veligrotug fitting relative to existing biologic options for TED, and are there particular patient populations that may be especially well-suited for this therapy?

Douglas: I anticipate veligrotug will be particularly well-suited for patients whose primary complaint is diplopia (double vision), as this symptom is often one of the most disabling aspects of TED which affects driving, reading, and navigating daily life.

Leibowitz: Having participated in the veligrotug clinical trials, I find that the veligrotug data, which demonstrate significant improvements for proptosis and diplopia, a rapid onset of benefit after just one infusion, and a shorter course of treatment, will resonate with both patients and treating physicians. What also distinguishes veligrotug is its demonstrated efficacy across both active and chronic TED, addressing the full spectrum of moderate-to-severe disease. For clinicians, veligrotug broadens the conversation considerably as we've historically had limited options for patients in the chronic phase who are still experiencing significant disease burden.

Diplopia (double vision) has a profound impact on patients' daily activities, like driving, reading and using their phones. Phase 3 data show statistically significant clinical diplopia response and complete resolution in patients with active and chronic TED.

Murdock: This is an interesting question because, without a head-to-head comparison between veligrotug and teprotumumab, it will take time and real-world experience to determine where each therapy fits best. Although the available data suggest similar effects on proptosis, diplopia, and inflammatory symptoms, we don't yet know which patients may derive greater benefit from one agent versus the other, so I anticipate my treatment decisions will evolve as we gain more clinical experience.

In the meantime, I can see veligrotug being particularly attractive for patients who value a shorter 12-week treatment course, especially those who are family planning. I also think insurance coverage will play a major role in how these therapies are used in the United States. I have patients with recurrent inflammatory TED who have had difficulty obtaining approval for teprotumumab, so an additional option may be helpful if it creates another pathway for coverage in patients with inflammatory flares in this chronic disease.

Looking ahead, how do you see the TED treatment landscape evolving as additional targeted therapies and subcutaneous agents advance through development?

Douglas: The approval of a second targeted biologic marks the beginning of a new phase in TED care in which we can truly tailor therapy based on disease stage, symptom profile, and patient preference rather than relying on a single option for everyone.

It still remains unclear how subcutaneous therapies will ultimately fit into the treatment hierarchy, because they will need to demonstrate not only convenience but also efficacy. If they can achieve that bar, I could imagine a future paradigm where we use potent intravenous regimens like veligrotug or teprotumumab as induction therapy in more severe cases, and then consider subcutaneous options as maintenance or for milder disease, giving patients and clinicians a much more flexible treatment approach.

Leibowitz: In my experience, when patients are evaluating treatment for TED, the practical realities, such as time away from work, travel to infusion centers, length of the regimen and possible side effects, weigh heavily on their decision-making. That's an area where existing options have had limitations. The innovation we're seeing in this space, especially the development of Viridian’s subcutaneous autoinjector that would allow patients with TED to self-administer treatment at home in just a few seconds, has real potential to further reduce those barriers. Clinical trials in progress include new subcutaneous treatments, oral treatments, other treatment regimens blocking other pathways (not IGF-1) in the TED inflammatory response and even gene therapy treatments for TED. I’m encouraged by the direction the field is heading and look forward to seeing how additional options may expand access and improve the overall treatment experience for patients.

Murdock: The biggest benefit is that we will have more options to treat a very heterogeneous disease. TED does not look the same in every patient, and different patients may ultimately need different therapeutic strategies depending on disease activity, phenotype, comorbidities, access, and treatment goals.

Time will tell which therapy is best suited for which patient population, but it is an exciting time in TED. Six years ago, our options were largely limited to steroids, surgery, and more broadly immunosuppressive or higher-risk biologic therapies. Now we are moving toward more targeted, effective treatment options for different types and stages of TED, which is a major step forward for both physicians and patients.

Raymond S. Douglas MD, PhD

E: [email protected]

Douglas is a TED specialist and oculoplastic surgeon practicing in Beverly Hills, California, and professor of surgery in the Division of Ophthalmology at Cedars‑Sinai in the Los Angeles metropolitan area. He is also founder of Thrive Health and was lead investigator for the teprotumumab clinical trials.

Steven Leibowitz, MD

E: [email protected]

Leibowitz is clinical professor of ophthalmology, Stein Eye Institute, Geffen School of Medicine, University of California Los Angeles, and principal investigator for Viridian’s TED clinical trials for veligrotug (IV) and elegrobart (SC).

Jennifer Murdock, MD

E: [email protected]
Murdock is an oculofacial cosmetic and reconstructive surgeon practicing in Miami, Florida, with expertise in TED, eyelid and orbital reconstruction, and minimally invasive cosmetic injectables.

References

1. Viridian Therapeutics announces US FDA approval and launch of Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease. Viridian Therapeutics, Inc. News release. June 26, 2026. Accessed June 27, 2026. https://www.businesswire.com/news/home/20260625016249/en/Viridian-Therapeutics-Announces-U.S.-FDA-Approval-and-Launch-of-Lumvoa-veligrotug-vvze-for-the-Treatment-of-Thyroid-Eye-Disease

2. Ophthalmology Times Staff Reports. FDA approves veligrotug-vvze (Lumvoa) for thyroid eye disease across active and chronic stages. Ophthalmology Times. June 27, 2026. Accessed June 29, 2026. https://www.ophthalmologytimes.com/view/fda-approves-veligrotug-vvze-lumvoa-for-thyroid-eye-disease-across-active-and-ch

3. Amgen announces positive topline phase 3 results for subcutaneous Tepezza in adults living with moderate-to-severe active thyroid eye disease. Amgen. News release. April 6, 2026. Accessed June 29, 2026. https://www.amgen.com/newsroom/press-releases/2026/04/amgen-announces-positive-topline-phase-3-results-for-subcutaneous-tepezza-in-adults-living-with-moderate-to-severe-active-thyroid-eye-disease