Diabetic Retinopathy - Pipeline Insight, 2024

This “Diabetic Retinopathy- Pipeline Insight, 2024” report provides comprehensive insights about 50+ companies and 55+ pipeline drugs in Diabetic Retinopathy 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

Diabetic Retinopathy: Understanding

Diabetic Retinopathy: Overview

Diabetic retinopathy (DR) is a microvascular disorder that occurs due to the long-term effects of diabetes mellitus. Diabetic retinopathy may lead to vision-threatening damage to the retina, eventually leading to blindness. It is the most common cause of severe vision loss in adults of working age groups in the western world. Early detection and timely intervention are the keys to avoiding blindness due to diabetic retinopathy.

Diabetic retinopathy is subdivided into non-proliferative and proliferative retinopathy. Macular edema can arise at any stage of the disease and threaten visual acuity. The main risk factors for the development and progression of diabetic retinopathy are long duration of diabetes and poor control of blood sugar and arterial blood pressure. Laser photocoagulation is an evidence-based treatment for proliferative retinopathy and macular edema.

Diabetic retinopathy is a microangiopathy of the retina. It involves changes in the vascular wall and the rheological properties of the blood. The combination of these factors leads to capillary occlusion and thereby to retinal ischemia and angiographically demonstrable leakage. The typical histopathological changes include loss of pericytes and endothelial cells and thickening of the basilar membrane. Microaneurysms, i.e., sites of outward ballooning of the capillary wall, are pathognomonic.

Multiple biochemical signal pathways are involved. The increased activity of protein kinase C and protein glycosylation lead to the formation of advanced glycation end products (AGE). These, in turn, lead to cell interactions involving vascular endothelial growth factor (VEGF) that cause neo-vascularization in the anterior and posterior segments of the eye, increased vascular permeability resulting in leakage, and collapse of the inner blood-retina barrier. AGE are taken exogenously in food and are also formed endogenously in greater quantities because of hypoglycemia; they seem to mediate nearly all complications of diabetes, including the vasoconstriction and inflammatory vessel wall changes that are associated with the formation of atheromatous plaques and influence the functioning of endothelial cells and macrophages. Inflammatory changes in the vessel wall are the target of the current therapeutic approach employing the intravitreous injection of glucocorticoids. Other growth factors that play a role in the pathogenesis of diabetic retinopathy include insulin-like growth factors I and II, transforming growth factor ß, and pigment epithelium-derived growth factor.

Diabetic Retinopathy- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Diabetic Retinopathy pipeline landscape is provided which includes the disease overview and Diabetic Retinopathy treatment guidelines. The assessment part of the report embraces, in depth Diabetic Retinopathy 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, Diabetic Retinopathy 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 Diabetic Retinopathy R&D. The therapies under development are focused on novel approaches to treat/improve Diabetic Retinopathy.

Diabetic Retinopathy Emerging Drugs Chapters

This segment of the Diabetic Retinopathy report encloses its detailed analysis of various drugs in different stages of clinical development, including phase 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.

Diabetic Retinopathy Emerging Drugs

Brolucizumab: NovartisBrolucizumab (RTH258) is a humanized single-chain antibody fragment (scFv) and the most clinically advanced, humanized single-chain antibody fragment to reach this stage of development. Single-chain antibody fragments are highly sought after in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation, and drug delivery characteristics. The proprietary, innovative structure results in a small molecule (26 kDa) with potent inhibition of and high affinity to, all VEGF-A isoforms. In preclinical studies, brolucizumab inhibited activation of VEGF receptors through prevention of the ligand-receptor interaction. Increased signaling through the VEGF pathway is associated with pathologic ocular angiogenesis and retinal edema. Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions, resolve retinal edema and improve vision in patients with chorioretinal vascular diseases. Currently, the drug is in Phase III stage of development to treat
Diabetic Retinopathy.

RGX 314: Regenxbio Inc.RGX-314 is being developed as a novel, one-time subretinal treatment that includes the NAV AAV8 vector containing a gene encoding for a monoclonal antibody fragment. The expressed protein is designed to neutralize vascular endothelial growth factor (VEGF) activity, modifying the pathway for the formation of new leaky blood vessels and retinal fluid accumulation. The company is currently enrolling patients in ALTITUDE, a Phase II trial for the treatment of diabetic retinopathy using suprachoroidal delivery of RGX-314.

OTT-166: OcuTerra TherapeuticsOTT-166 is a novel small molecule selective integrin inhibitor that OcuTerra has purpose-engineered to have the required physiochemical characteristics to be able to reach the retina from eye drop application. Phase 1b clinical trials of OTT-166 eye drops have demonstrated safety, tolerability, and clear clinical evidence of biological activity. OcuTerra is currently studying the safety, efficacy, and optimal dosing regimen of OTT166 through the Phase II DR: EAM (Diabetic Retinopathy: Early Active Management) study in patients with moderately-severe to severe non-proliferative and mild proliferative diabetic retinopathy.

OTX-TKI: Ocular TherapeutixOTX-TKI is an investigational bioresorbable hydrogel implant incorporating axitinib, a small molecule tyrosine kinase inhibitor with anti-angiogenic properties. The drug is currently being evaluated in Phase I for the treatment of diabetic retinopathy.

Diabetic Retinopathy: Therapeutic Assessment

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

Major Players in Diabetic Retinopathy

• There are approx. 50+ key companies which are developing the therapies for Diabetic Retinopathy. The companies which have their Diabetic Retinopathy drug candidates in the most advanced stage, i.e. phase III include, Kodiak Sciences.

Phases

This report covers around 55+ 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

Diabetic Retinopathy 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.

Diabetic Retinopathy: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Diabetic Retinopathy 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 Diabetic Retinopathy drugs.

Diabetic Retinopathy Report Insights

• Diabetic Retinopathy Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Diabetic Retinopathy 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 Diabetic Retinopathy drugs?
• How many Diabetic Retinopathy drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Diabetic Retinopathy?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Diabetic Retinopathy 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 Diabetic Retinopathy and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Kodiak Sciences
• Novartis
• Regenxbio Inc.
• OcuTerra Therapeutics
• Ocular Therapeutix
• Bayer
• RemeGen
• Roche
• Ocuphire Pharma
• Adverum Biotechnologies
• Boehringer Ingelheim

Key Products

• KSI-301
• Brolucizumab
• RGX 314
• OTT-166
• OTX-TKI
• Runcaciguat
• RC 28 E
• RG7774
• APX3330
• ADVM-022
• Faricimab
• BI 764524

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