First approved treatment for thyroid eye disease (TED) with labeling that includes data for both active and chronic TED -

- In two pivotal phase 3 clinical trials, Lumvoa treatment showed rapid, consistent, and durable reductions of the key signs and symptoms of both active and chronic TED -

- Lumvoa is the first approved product for TED to show a statistically significant effect in both diplopia response and complete resolution of diplopia in active and chronic disease -

- Viridian plans to launch Lumvoa immediately, a pivotal milestone as the company’s first commercial product in TED with subcutaneous elegrobart on track for a biologics license application (BLA) submission in Q1 2027 -

- Viridian will host a conference call and webcast Monday, June 29 at 8:00 a.m. ET -

Viridian Therapeutics, Inc. (NASDAQ:VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Lumvoa™ (veligrotug-vvze) for the treatment of thyroid eye disease (TED). TED is a rare, debilitating autoimmune disease characterized by inflammation and tissue remodeling around and behind the eyes that can lead to proptosis, diplopia, pain, and vision impairment.

"With the approval of Lumvoa, we take a significant step forward in providing a meaningful treatment option for people living with thyroid eye disease," said Steve Mahoney, President and Chief Executive Officer of Viridian. "Lumvoa was designed with patient needs at the forefront and is Viridian’s first FDA-approved medicine and our first commercial product. This marks an important milestone for us and reflects years of focused execution by the Viridian cross-functional teams. Our commercial and medical affairs teams have been preparing for this moment for a long time, and in particular since receiving Breakthrough Therapy Designation last year. We are ready to support patients and physicians from day one."