In June 2026, Viridian Therapeutics’ Lumvoa™ (veligrotug-vvze) was approved by the US Food and Drug Administration (FDA) for the treatment of active and chronic thyroid eye disease (TED). Supported by data gathered by the THRIVE clinical program, Viridian states that the IGF-1R antagonist is “the first and only treatment to demonstrate statistically significant diplopia response and resolution in active and chronic TED.” Having previously been granted Breakthrough Therapy Designation and Priority Review, the biotech company now plans to make the treatment commercially available throughout the US.

Following on from the FDA approval, The Ophthalmologist sat down with Michael Yen, Professor of Oculoplastic Surgery and Ophthalmology at Baylor College of Medicine and a THRIVE investigator, to learn more about the new thyroid eye disease treatment.

From your perspective as an oculoplastic surgeon, what makes thyroid eye disease such a challenging condition to treat?

Patients are significantly affected by thyroid eye disease, not just from an objective, measurable, functional standpoint, but also from an emotional and psychological standpoint. Traditionally, we didn't really have very good treatment options to offer these patients. If you look back seven or eight years ago, we did not have strong evidence that any medical therapies had a significant impact on proptosis or diplopia.  We had some surgical options that we could offer, but there are limitations and risks with surgical outcomes. So I think that's the greatest challenge that we've always had with thyroid eye disease – we have never really had a truly effective treatment, in terms of outcomes regarding the measures that patients are really concerned about.

What is your reaction to the recent FDA approval of Lumvoa for both active and chronic TED?

The challenges of taking care of thyroid disease patients, that all changed around five or six years ago when we had teprotumumab first come on the market. Teprotumumab really was the first time where we had a medication that truly impacted and affected those outcome measures that mean the most to patients, such as proptosis reduction and diplopia resolution. And Lumvoa is in the same class – it's targeting the IGF-1 receptor, and I think it's really a meaningful and significant addition to our armamentarium of being able to better treat thyroid eye disease patients.

How do you see this approval potentially changing the TED treatment landscape?

With Lumvoa, we saw in the clinical trials almost 3 millimeters of proptosis reduction, which is a tremendous amount of improvement. Additionally, there was significant improvement in diplopia as well. For patients who have double vision, it's very difficult to engage in their ordinary daily activities – watching TV or just driving can be stressful and difficult for them. So these are significant improvements in terms of their visual function, in terms of their appearance, and in terms of their quality of life.

As a THRIVE investigator, what were the most clinically meaningful outcomes observed in the program?

All of the primary and secondary outcome measures that we were looking at had a significant response. For proptosis reduction, the vast majority of patients – around 70% – had a reduction of greater than two millimeters. Diplopia response – or improvement in double vision – was also close to 60%. So those outcome measures were significant, and those are the ones that I think patients really care about the most.

The flip side to these medications is that sometimes they can have side-effects. And I think relative to what's already out there on the market, Lumvoa had a very good side-effect profile in the clinical trial, with low rates of adverse events being reported. The side-effect that gets a lot of publicity with TED medications is changes in patients’ hearing – they sometimes report a feeling of fullness in the ear, or things begin to sound a little muffled. In the clinical trial for Lumvoa, hearing symptoms were reported at about 5%, placebo adjusted.

What factors should clinicians consider when discussing Lumvoa with eligible patients?

I think the most important factor is having a good clinical exam and having an accurate diagnosis using objective measures. For most patients with thyroid eye disease the signs and symptoms are fairly obvious, but it doesn't mean that that's necessarily the only thing that can cause these symptoms (e.g. proptosis or diplopia). We have certainly seen some unfortunate cases over the years with teprotumumab, where patients were presumed to have thyroid eye disease and then initiated on treatment and ended up not having thyroid eye disease. So first and foremost for clinicians, it’s very important to have a good objective clinical exam and to make sure we have an accurate diagnosis.

The second thing is I think it's crucial to have a detailed discussion with the patient about what to expect from their treatment. Patient compliance is obviously very important for successful outcomes, and many times we'll see improvement in the signs and symptoms after just a couple of treatments. With Lumvoa, the treatment course is administered over 12 weeks as five intravenous infusions, each given every three weeks. From the THRIVE and THRIVE-2 clinical trials, reduction of proptosis symptoms were seen as early as three weeks. But I think it's important to have periodic follow-up, periodic clinical exams throughout the treatment course, and to stress to the patient the importance of compliance as well.

With these treatments, there's always the possibility of having reactivation or a sort of relapse of the condition. We didn't see that to a significant degree in the trial – at 52 weeks we saw 70% maintain their proptosis response rate – but it wasn’t 100%.

So there can be some reactivation or relapses, which I don't think is necessarily surprising because if we think of this as an autoimmune condition, any other autoimmune condition would also have these chances of relapse. But for thyroid eye disease patients, it's important to stress that this is not a treat once and then you're done for the rest of your life scenario. They need to have continued follow-up examinations and continued awareness about their ocular signs and symptoms so that we can identify any patients that do relapse.

What additional research questions remain in TED treatment?

I think the biggest question that many clinicians and researchers have is exactly what I just mentioned about those patients that do relapse or that have reactivation – What are the unique characteristics of these patients? And can we identify these patients early on so that we can alter their treatment recommendations?

In this regard, I think there's definitely much more to be learned. I often tell my colleagues that the more experience I have with treating thyroid eye disease these last few years, the more I question our previously accepted knowledge of the disease. It makes me re-question what I thought I knew for 20 years. And I think that's what makes this period of time right now a very exciting time for thyroid eye disease. Not only are we having new treatments that are effective that we can offer to our patients, but it is also forcing us to re-examine what we think we know about the disease. In turn, this is leading to more research and more discoveries and a better, more accurate understanding of thyroid eye disease.

What is the single most important takeaway for clinicians from the Lumvoa approval?

The biggest takeaway is that we now have another medication that has been shown to have a significant improvement in both proptosis and diplopia.

One of the common pushbacks we oftentimes encounter with insurance companies is that they often first want to implement other therapies and have patients fail, say, corticosteroid therapy, or they want patients to have surgery as a first step. 

But I don't think that there's good medical evidence to support that requirement. When we look at IGF-1 receptor antagonists – the recently-approved Lumvoa and tepretumumab – we have clinical trial data that shows significant improvement for patients with thyroid eye disease. Really, these should be viewed as the first-line treatments for thyroid eye disease. If we’re advocating for evidence-based decision-making in medicine, then we really should be looking at the clinical trial results for these IGF-1 receptor antagonists, because it's really the only treatment that has been shown to be effective for the disease.