Eye on 2025: Viridian Sets Priorities After Positive Phase 3 TED Data
Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company committed to developing potential best-in-class treatments for serious and rare diseases, has outlined its corporate priorities and upcoming catalysts for 2025. The company recently announced positive topline results for veligrotug in the THRIVE and THRIVE-2 Phase 3 trials for thyroid eye disease (TED), bolstering their confidence in future milestones.
Steve Mahoney, President and CEO of Viridian, shared, “Entering 2025, we are well-positioned to deliver on several important catalysts. The better-than-expected topline data for veligrotug in both THRIVE and THRIVE-2 confirm its potential as the treatment-of-choice for all forms of active and chronic TED upon its anticipated commercial launch. We are progressing with our Biologics License Application (BLA) submission and early commercial preparations, planning to submit the BLA in the second half of 2025. The results from these trials also strengthen our confidence in our subcutaneous VRDN-003 program, which is expected to deliver positive topline data by mid-2026, paving the way for a BLA submission later that year.”
Viridian’s pipeline extends beyond TED, with a promising portfolio in the field of FcRn inhibitors. In the third quarter of 2025, the company expects proof-of-concept data from its VRDN-006 Phase 1 trial in healthy volunteers, which will include IgG reduction results. The company is also advancing its bispecific, half-life extended FcRn inhibitor, VRDN-008, which has shown encouraging preclinical data in non-human primates (NHPs), including a significantly longer half-life compared to efgartigimod and sustained IgG reduction. Viridian plans to share more preclinical data for VRDN-008 later this year, continuing to advance its portfolio.
TED Portfolio: Veligrotug and VRDN-003 Positioned for Success
Veligrotug: A Potential IV Treatment of Choice for Active & Chronic TED
Veligrotug, Viridian’s lead product candidate, is a monoclonal antibody that fully antagonizes the insulin-like growth factor-1 receptor (IGF-1R), a key player in TED. In late 2024, Viridian reported positive topline results for veligrotug in two significant global Phase 3 trials, THRIVE and THRIVE-2, for the treatment of active and chronic TED, respectively. The company plans to submit a BLA for veligrotug for both active and chronic TED patients in the second half of 2025.
In the THRIVE trial for active TED, veligrotug met all primary and secondary endpoints with strong statistical significance. Key findings included a 54% resolution of diplopia (double vision) in treated patients and rapid improvement in proptosis (eye bulging), with the majority of patients seeing a response after just one infusion. Veligrotug was well tolerated, with no treatment-related serious adverse events and a low rate of hearing impairment adverse events (AEs) at 5.5%, which is significantly lower than the placebo-adjusted rate.
The THRIVE-2 trial, conducted in chronic TED patients, also yielded positive topline results in December 2024, meeting all primary and secondary endpoints with high statistical significance. For the first time, veligrotug demonstrated a significant and clinically meaningful reduction and resolution of diplopia in chronic TED patients. Additionally, the drug showed a rapid onset of action, with a statistically significant proptosis response observed as early as 3 weeks and diplopia resolution as early as 6 weeks. Together, these trials, the largest and broadest studies of their kind, confirm veligrotug’s potential as a best-in-class intravenous (IV) treatment for all forms of active and chronic TED, particularly those impacting the eye.
Subcutaneous VRDN-003: A Potential Best-In-Class Treatment for TED
VRDN-003, a subcutaneous monoclonal antibody targeting IGF-1R, shares the same binding domain as veligrotug and is engineered for an extended half-life. This half-life extension—confirmed to be 40-50 days—supports infrequent dosing, potentially as little as once every 8 weeks. Following the success of THRIVE and THRIVE-2, Viridian is confident that VRDN-003 will become a best-in-class subcutaneous treatment for TED, especially in patients who require a long-term eye care solution.
Currently, the company is conducting two global Phase 3 trials for VRDN-003, REVEAL-1 and REVEAL-2, in active and chronic TED patients, respectively. The topline results for both studies are expected in the first half of 2026, which will set the stage for a BLA submission in late 2026. VRDN-003 will be delivered via an autoinjector, offering a convenient self-administration option for patients who need consistent eye care.
FcRn Inhibitor Portfolio: VRDN-006 and VRDN-008
Viridian’s FcRn inhibitor portfolio holds promise for treating a wide range of autoimmune diseases. The company introduced VRDN-006 and VRDN-008 in October 2023, both designed to improve patient outcomes by reducing IgG levels while sparing essential proteins like albumin, which can help maintain eye health.
VRDN-006: This Fc fragment inhibitor is designed as a convenient subcutaneous treatment option. Viridian expects to initiate a Phase 1 clinical trial for VRDN-006 in healthy volunteers in early 2025, with proof-of-concept data expected by Q3 2025.
VRDN-008: This bispecific FcRn inhibitor has shown a threefold longer half-life than efgartigimod in preclinical studies and has demonstrated deeper, more sustained IgG reduction. Viridian expects to share additional preclinical data from NHP studies later in 2025, advancing the development of this promising therapeutic for conditions that affect the eye, as well as other related diseases.
Viridian’s pipeline is showing great promise in the treatment of TED, autoimmune disorders, and beyond, with exciting developments anticipated for the eye and other organ systems over the coming years.
