Viridian Therapeutics has received approval from the US Food and Drug Administration (FDA) for Lumvoa (veligrotug-vvze) for the treatment of Thyroid Eye Disease (TED), a rare autoimmune disorder that causes inflammation and tissue remodelling around the eyes, leading to symptoms such as proptosis, double vision, pain and vision impairment.

The approval marks Viridian's first FDA-approved medicine and commercial product. Lumvoa was reviewed under the FDA's Priority Review pathway after previously receiving Breakthrough Therapy Designation. The company said it will launch the therapy immediately, enabling physicians in the US to begin prescribing the treatment without delay.

Lumvoa is the first approved insulin-like growth factor-1 receptor (IGF-1R) antagonist indicated for both active and chronic forms of thyroid eye disease. The approval is supported by positive results from the pivotal Phase 3 THRIVE and THRIVE-2 clinical trials, which evaluated the therapy in patients with active and chronic TED, respectively.

According to the company, both studies met their primary and all secondary endpoints, demonstrating statistically significant improvements in key disease outcomes, including reductions in eye bulging (proptosis) and improvements in double vision (diplopia) after a 12-week treatment course comprising five intravenous infusions administered every three weeks. Clinical benefits were observed as early as three weeks after treatment initiation.

Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics, said the approval represents a major milestone for the company and expands treatment options for patients living with TED.

Clinical investigator Michael Yen, Professor of Oculoplastic Surgery and Ophthalmology at Baylor College of Medicine, said the clinical programme demonstrated meaningful benefits across the full spectrum of thyroid eye disease, including rapid improvements in proptosis and diplopia, offering physicians an important new treatment option.

Viridian also announced the launch of ViridianCares, a patient support programme designed to provide insurance assistance, access support, benefit verification and financial assistance for eligible patients to facilitate treatment access.

The company noted that Lumvoa's prescribing information includes warnings regarding infusion-related reactions, inflammatory bowel disease exacerbation, hyperglycaemia and hearing impairment. Patients receiving the therapy are advised to undergo appropriate monitoring during and after treatment.