Graves' Ophthalmopathy - Pipeline Insight, 2025

DelveInsight's, "Graves' Ophthalmopathy - Pipeline Insight, 2025" report provides comprehensive insights about 15+ companies and 20+ pipeline drugs in Graves' Ophthalmopathy pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Graves' Ophthalmopathy: Understanding

Graves' Ophthalmopathy: Overview

Graves' Ophthalmopathy (GO), also known as Graves' Orbitopathy or Thyroid Eye Disease (TED), is an autoimmune disorder that primarily affects the retro-ocular tissues, often occurring in patients with hyperthyroidism due to Graves' disease. However, it can also sporadically develop in patients who are euthyroid or hypothyroid, particularly those with chronic autoimmune thyroiditis. This condition is characterized by a constellation of signs and symptoms, including eye bulging, double vision, and inflammation, which can be sight-threatening in its severe form. GO has an annual incidence rate of 16 women and 3 men per 100,000 population. Despite being studied for nearly two centuries, the pathophysiology of Graves' Ophthalmopathy remains complex, with ongoing research into its mechanisms and potential targeted therapies. Prompt diagnosis and management are critical to prevent vision impairment and improve patient outcomes.

Graves' ophthalmopathy (GO) is primarily driven by thyroid-stimulating hormone (TSH) receptor antibodies, which act on TSH receptors found not only in the thyroid but also in various extrathyroidal tissues, including retro-ocular tissues. Studies suggest that TSH receptors are more abundantly expressed in the retro-ocular tissue of patients with Graves' disease, contributing to the development of GO. Several factors increase the risk of orbitopathy in Graves' disease, including higher levels of TSH receptor antibodies, female gender, genetic predispositions (although specific genes remain unidentified), and exposure to radioiodine treatment. Smoking is the most significant modifiable risk factor, exacerbating the severity of GO and reducing the response to treatment by affecting both humoral and cell-mediated immunity.

Thyroid Eye Disease (TED) typically follows a self-limiting course due to the absence of orbital lymphoid tissue, with its natural history divided into phases. The initial phase is characterized by a steep rise in disease severity, lasting from six months to five years, with an average duration of two years. This is followed by an inflammatory phase, during which the disease remains active. After approximately 18 months, TED stabilizes and enters the inactive phase, where regression occurs, although residual fibrotic changes in the orbit persist. Aggressive immunosuppressive treatment during the active phase can limit the destructive and fibrotic effects of the immune process. Once the disease becomes inactive, it is less responsive to medical management, often necessitating surgical intervention.

The treatment of Graves' Ophthalmopathy (GO) is tailored based on disease severity and includes both supportive and specific measures. Supportive care, such as ocular lubrication, eye patches, prism correction for diplopia, and elevating the head of the bed, is essential for all patients. Selenium may benefit those with mild disease in selenium-deficient areas, while smoking cessation and achieving euthyroidism are crucial. Medical treatments for moderate-to-severe disease include glucocorticoids, with intravenous methylprednisolone preferred for severe cases, though side effects require careful monitoring. Second-line options include immunomodulators like rituximab, mycophenolate, external orbital radiation, and orbital decompression surgery. Teprotumumab, an IGF-1 receptor antagonist, has shown promise in clinical trials for moderate-to-severe active disease. In sight-threatening cases, immediate hospitalization with intravenous glucocorticoids and potential urgent orbital decompression surgery is required. Surgical options, including orbital decompression and corrective procedures for lid retraction and muscle restriction, are considered for those who do not respond to medical management. In children and pregnant patients, the treatment approach is adapted to minimize risks, with antithyroid drugs being the primary therapy, and steroids or surgery reserved for severe cases. Radiation therapy is generally avoided due to its side effects, especially in pediatric and pregnant populations.

"Graves' Ophthalmopathy- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Graves' Ophthalmopathy pipeline landscape is provided which includes the disease overview and Graves' Ophthalmopathy treatment guidelines. The assessment part of the report embraces, in depth Graves' Ophthalmopathy commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Graves' Ophthalmopathy collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Graves' Ophthalmopathy R&D. The therapies under development are focused on novel approaches to treat/improve Graves' Ophthalmopathy.

Graves' Ophthalmopathy Emerging Drugs Chapters

This segment of the Graves' Ophthalmopathy report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Graves' Ophthalmopathy Emerging Drugs

• IBI311: Innovent Biologics (Suzhou) Co. Ltd.

IBI311 is a recombinant anti-IGF-1R antibody developed by Innovent for the treatment of TED. IGF-1R is a transmembrane tyrosine kinase receptor that plays a role in the development, metabolism, and immune regulation, and is overexpressed in OFs, B, and T cells of TED patients. IBI311 can bind IGF-1R, block IGF-1R signaling pathway activation mediated by IGF-1 and other related ligands or agonistic antibodies, reduce the expression of downstream inflammatory factors, thereby inhibiting the synthesis of hyaluronic acid and other glycosaminoglycan caused by OFs activation, as well as related inflammatory reactions including tissue congestion and edema; inhibit adipocyte cellularization of OFs, thereby reducing the disease activity of patients with TED and improving proptosis, diplopia, ocular congestion and edema among other symptoms and signs. Currently, the drug is in Registration stage of its development for the treatment of Graves' Ophthalmopathy.

• VRDN-001: Viridian Therapeutics, Inc.

Veligrotug (VRDN-001), is a potential best-in-class, IV monoclonal antibody targeting IGF-1R. IGF-1R, a transmembrane receptor that plays a role in development, metabolism, and immune regulation, is a clinically and commercially validated target for the treatment of TED. Based on work in the field, IGF-1R and the co-located thyroid stimulating hormone receptor (TSHR) have been found to play a key role in the pathogenesis of TED. Veligrotug (VRDN-001) acts as a full antagonist of IGF-1R, and based on clinical data to date, has demonstrated robust clinical activity and is generally well-tolerated compared with the currently approved anti-IGF-1R antibody.1. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Graves' Ophthalmopathy.

• Lonigutamab: ACELYRIN Inc.

Lonigutamab is a humanized IgG1 monoclonal antibody targeting the insulin-like growth factor 1 (IGF-1) receptor and is delivered subcutaneously. Relative to standard of care, lonigutamab binds to a distinct epitope, which results in internalization of the receptor within minutes. The characteristics of lonigutamab that enable subcutaneous delivery also enable the potential for longer-term, convenient dosing, which can potentially improve depth and durability of clinical response. Lonigutamab, with its unique mechanism of action, is the first subcutaneous anti-IGF-1R to have demonstrated robust efficacy in TED patients comparable to the IV administered standard of care. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of Graves' Ophthalmopathy.

• KRIYA 586: Kriya Therapeutics

KRIYA-586 is a potential one-time gene therapy for TED engineered to express an antibody that inhibits IGF1R, a key target implicated in the pathogenesis of TED. KRIYA-586 is designed for one-time delivery through a focal peribulbar injection performed in the office, with the goal of providing local and durable expression of anti-IGF1R antibody from transduced periorbital fat and muscle cells to help address the ocular manifestations of TED while minimizing systemic toxicities. It produces localized antibody expression in extraocular muscles and fat tissue, with low systemic exposure to limit the potential for side effects. It produces AAV-mediated anti-IGF1R expression to deliver sustained improvements in proptosis and diplopia as well as other key manifestations of TED. Currently, the drug is in Preclinical stage of its clinical trial for the treatment of Graves' Ophthalmopathy.

Graves' Ophthalmopathy: Therapeutic Assessment

This segment of the report provides insights about the different Graves' Ophthalmopathy drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Graves' Ophthalmopathy
• There are approx. 15+ key companies which are developing the therapies for Graves' Ophthalmopathy. The companies which have their Graves' Ophthalmopathy drug candidates in the most advanced stage, i.e. Phase II include, Innovent Biologics (Suzhou) Co. Ltd.
• Phases

DelveInsight's report covers around 20+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Graves' Ophthalmopathy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Graves' Ophthalmopathy: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Graves' Ophthalmopathy therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Graves' Ophthalmopathy drugs.

Graves' Ophthalmopathy Report Insights

• Graves' Ophthalmopathy Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Graves' Ophthalmopathy Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Graves' Ophthalmopathy drugs?
• How many Graves' Ophthalmopathy drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Graves' Ophthalmopathy?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Graves' Ophthalmopathy therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Graves' Ophthalmopathy and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Innovent Biologics (Suzhou) Co. Ltd.
• Viridian Therapeutics, Inc.
• ACELYRIN Inc.
• Kriya Therapeutics
• Tourmaline Bio, Inc.
• Sinocelltech Ltd.
• Hoffmann-La Roche
• Immunovant Sciences GmbH
• H. Lundbeck A/S
• Sling Therapeutics, Inc.
• Lassen Therapeutics Inc.
• Changchun GeneScience Pharmaceutical Co., Ltd.
• argenx
• Amgen
• Minghui Pharmaceutical (Shanghai)

Key Products

• IBI311
• VRDN-001
• Lonigutamab
• KRIYA 586
• TOUR006
• SCTT11
• Satralizumab
• Batoclimab
• Lu AG22515
• Linsitinib
• LASN01
• GenSci098
• Efgartigimod
• AMG 732
• MHB 018A