Diabetic Retinopathy - Pipeline Insight, 2023

DelveInsight's , "Diabetic Retinopathy - Pipeline Insight, 2023" 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 major complication of diabetes mellitus (DM), which remains a leading cause of visual loss in working-age populations. The retina contains photoreceptor cells that function in the process of visual transduction, i.e., transforming light signals to nerve impulses eventually transmitted from the optic nerve to the brain forming an image. In mammals, the retina is supplied with oxygen and nutrients by the retinal and choroidal circulatory systems, and most major causes of retinopathy involve damage to these systems. The retinal circulation supplies the inner (towards the center of the eye) half of the retina and the choroidal circulation supplies the outer half of the retina. Light must pass through the retinal capillaries (and some neuronal layers) before striking the photoreceptors (see Figure). The choroid lies behind the retinal pigment epithelium (RPE). The RPE, the macula, and anterior segment of the optic nerve depend on the choroidal circulation for oxygen and nutrients (see Figure). Lack of sufficient blood flow in the retinal circulation can lead to optic neuropathy and vision loss. Rupture of the retinal capillaries can lead to bleeding into the vitreous humor (vitreous hemorrhage) and vision loss.

The diagnosis of DR is made by clinical manifestations of vascular abnormalities in the retina. Clinically, DR is divided into two stages: non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR). NPDR represents the early stage of DR, wherein increased vascular permeability and capillary occlusion are two main observations in the retinal vasculature. During this stage, retinal pathologies including microaneurysms, hemorrhages and hard exudates can be detected by fundus photography although the patients may be asymptomatic. PDR, a more advanced stage of DR, is characterized by neovascularization. During this stage, the patients may experience severe vision impairment when the new abnormal vessels bleed into the vitreous (vitreous hemorrhage) or when tractional retinal detachment is present. The most common cause of vision loss in patients with DR is diabetic macular edema (DME). DME is characterized by swelling or thickening of the macula due to sub- and intra-retinal accumulation of fluid in the macula triggered by the breakdown of the blood-retinal barrier (BRB). DME can occur at any stage of DR and cause distortion of visual images and a decrease in visual acuity.

The vast majority of newborns with retinopathy of prematurity have a mild form of the disease (stages 1 and 2), and their condition improves without any treatment. Careful monitoring and delivery of oxygen therapy have reduced oxygen toxicity. About 8 to 10% of newborns with ROP require medical intervention such as laser therapy or cryotherapy.

Lifestyle modifications are usually the first tier of preventative treatment for most of the retinopathies described above. These modifications could include weight loss, dietary changes such as portion control, aerobic exercise (e.g., greater than 130 steps per min), smoking cessation, reduction/elimination of alcohol and maintaining normal lipoprotein-cholesterol levels. For hypertensive retinopathy, excellent, cost-effective hypertensive medications are readily available. For diabetic retinopathy, glycemic control is a crucial factor. For proliferative diabetic retinopathy, exercise requires particular caution due to the increased risk of retinal hemorrhage and retinal detachment. Any exercise that increases blood pressure should be avoided. Metformin, a medication used to treat type 2 diabetes, slows the development of diabetic retinopathy. AMD specific treatments include dietary supplementation with antioxidant nutrients, injection of ranibizumab, and implantation of a miniature telescope in patients with end-stage macular degeneration. Ranibizumab is a monoclonal antibody fragment that inhibits VEGF. There are several maternal lifestyle risk factors for premature or low birth weight infants that could be modified to help prevent ROP, e.g., smoking cessation, early care during pregnancy, dealing with substance abuse disorders and minimizing stress.

"Diabetic Retinopathy- Pipeline Insight, 2023" report by DelveInsight 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

• KSI-301: Kodiak Sciences

KSI-301 is a novel anti-VEGF biologic designed to have an extended ocular half-life. Ischemia due to vein occlusion results in the secretion of vascular endothelial growth factor (VEGF), which causes further vascular leakage and edema. Anti-VEGF agents have become a very common treatment to improve the clinical outcomes of patients with diabetic retinopathy. As in wet AMD, an intensive treatment frequency is required to achieve optimal outcomes with currently-approved anti-VEGF agents. However, many patients are lost to follow-up due to the frequent injections and real-world outcomes in diabetic retinopathy do not meet the promise shown in clinical trials. By extending on the mechanism treatment interval, KSI-301 may relieve the high treatment burden for patients, their family members, and physicians. KSI-301 is being developed in Phase III stage of development towards a once every four to six-month treatment regimen - a possible gamechanger that may provide the opportunity for real prevention.

• Brolucizumab: Novartis

Brolucizumab (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 Therapeutics

OTT-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 Therapeutix

OTX-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.

Further product details are provided in the report……..

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

DelveInsight's 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
• Palatin Technologies
• Valo Health
• EyePoint Pharmaceuticals
• Kubota Vision
• MingSight Pharmaceuticals
• Oxurion
• Aerie Pharmaceuticals
• AsclepiX Therapeutics
• Ocugen
• Ashvattha Therapeutics
• Stealth BioTherapeutics

Key Products

• KSI-301
• Brolucizumab
• RGX 314
• OTT-166
• OTX-TKI
• Runcaciguat
• RC 28 E
• RG7774
• APX3330
• ADVM-022
• Faricimab
• BI 764524
• PL8331
• OPL-0401
• EYP-1901
• emixustat hydrochloride
• MS-553
• THR-149
• AR-13503
• AXT107
• OCU200
• D 4517.2
• Elamipretide