An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)

Key Inclusion Criteria:

• Must have moderate to severe active TED with documented evidence of ocular symptomsor signs that began within 15 months prior to screening

• Must have a Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the studyeye

• Must agree to use highly effective contraception as specified in the protocol

• Female TED participants must have a negative serum pregnancy test at screening

Key Exclusion Criteria:

• Must not have received prior treatment with another anti-IGF-1R therapy

• Must not have received systemic corticosteroids or steroid eye drops for anycondition, including TED, or selenium within 2 weeks prior to first dose

• Must not have received other immunosuppressive drugs for any condition, includingTED, or any other therapy for TED within 12 weeks prior to first dose.

• Must not have received an investigational agent for any condition, including TED,within 8 weeks or longer duration (depending on the type of investigational agent)prior to first dose

• Must not have received radioactive iodine (RAI) treatment within 8 weeks prior tofirst dose

• Must not have had previous orbital irradiation or decompression surgery for TED tothe study eye's orbit

• Must not have a pre-existing ophthalmic condition in the study eye which in thestudy doctor's opinion, would interfere with interpretation of study results

• Must not have abnormal hearing test before first dose. Must also not have a historyof ear conditions considered significant by study doctor

• Must not have a history of inflammatory bowel disease

• Female TED participants who must not be pregnant or breastfeeding

NOTE: There are additional eligibility criteria for participants who do not have a meaningful response at Week 24 (irrespective of initial treatment arm) who may receive additional injections of VRDN-003. These are described in the protocol.