DelveInsight’s, “Diabetic macular edema – Pipeline Insight, 2021,” report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in Diabetic macular edema 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.
• Global coverage
Diabetic macular edema Understanding
Diabetic macular edema: Overview
Diabetic Macular Edema (DME) is an eye condition which can occur in people living with diabetes – both type 1 and type 2. Consistently high blood sugar due to poor glucose control over time can damage small blood vessels in the body, including the eye. Diabetic retinopathy is a disease that damages the blood vessels in the retina, resulting in vision impairment. Left untreated, fluid can leak into the center of the macula, called the fovea, the part of the eye where sharp, straight-ahead vision occurs. The fluid makes the macula swell, blurring vision. This condition is called DME. It can occur at any stage of diabetic retinopathy, although it is more likely to occur as the disease progresses. Vision changes due to DME are: Blurred vision, Double vision, and Sudden increase in eye floaters. A detailed history including the approximate date of onset of diabetes, the use of insulin vs. oral antihyperglycemic agents, and the quality of metabolic control (e.g., HbA1c level) should be elicited. Maintaining good blood sugar, blood pressure, and cholesterol control helps prevent DME. Receiving a comprehensive dilated eye exam at least once a year, or more often as directed by the eye doctor. Laser light is used to close and destroy leaking blood vessels. This form of laser therapy does not typically cause pain. The treatment may leave permanent blind spots in a person’s vision. Anti-vascular endothelial growth factor (anti-VEGF) drugs block the development of new blood vessels and limit the leakage from the abnormal blood vessels in the eye.
Diabetic macular edema - Pipeline Insight, 2021 report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Diabetic macular edema pipeline landscape is provided which includes the disease overview and Diabetic macular edema treatment guidelines. The assessment part of the report embraces, in depth Diabetic macular edema 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 macular edema collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
• The companies and academics are working to assess challenges and seek opportunities that could influence Diabetic macular edema R&D. The therapies under development are focused on novel approaches to treat/improve Diabetic macular edema.
Diabetic macular edema Emerging Drugs Chapters
This segment of the Diabetic macular edema 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 macular edema Emerging Drugs
• MYL-1701P: Mylan Pharmaceuticals
MYL-1701P (also referred to as M710, as part of a partnership with Momenta Pharmaceuticals) is perhaps the aflibercept biosimilar that is furthest along in the development process. It is currently the subject of a 324-patient phase III trial. Mylan is to handle development and commercialization. Mylan believes that it will file a 351(k) submission by early 2021, which could mean an FDA decision in early Q1 2022. Mylan is now part of Viatris, a new global healthcare company committed to empowering people to live healthier at every stage of life.
• KSI-301: Kodiak sciences
KSI-301 is a novel anti-VEGF biologic built on a propriety antibody biopolymer conjugate (ABC) platform KSI-301 is designed to have extended ocular half-life, higher potency, and improved ocular tissue bioavailability. KSI-301 is administered as an intravitreal injection and designed to provide sustained inhibition of VEGF for up to 6 months. The unique properties of KSI- 301 aim to provide patients with long-term control of their DME with improved vision outcomes while reducing the burden of frequent anti-VEGF injections. In addition, KSI-301 is designed to halt and reverse DR progression with long-term efficacy that can reduce the risk of vision-threatening complications from DR. The Phase III GLEAM and GLIMMER studies are global, multi-center, randomized studies designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve diabetic macular edema (DME).
• Brolucizumab: Novartis
Beovu (brolucizumab, also known as RTH258) is approved for the treatment of wet age-related macular degeneration (AMD) in more than 60 countries, including in the US, EU, UK, Japan, Canada and Australia. Additional trials, which study the effects of brolucizumab in patients with wet AMD, DME, retinal vein occlusion (RVO) and proliferative diabetic retinopathy (PDR), are currently ongoing. In KESTREL and KITE, Beovu (brolucizumab) 6 mg met the primary endpoints of non-inferiority in change in best corrected visual acuity from baseline versus aflibercept 2 mg at year one in diabetic macular edema (DME) patients.
• CT-P42: Celltrion
Celltrion Inc. has begun a Phase III clinical trial of CT-P42, an aflibercept biosimilar referencing Regeneron’s Eylea. The trial will enroll 300 patients with diabetic macular edema, and aims to compare CT-P42’s efficacy, safety, pharmacokinetics, and immunogenicity against Eylea.
• UBX1325: Unity Biotechnology
UBX1325, a potent Bcl-xL inhibitor, is currently being evaluated for the treatment of age-related diseases of the eye – including diabetic macular edema, diabetic retinopathy, and age-related macular degeneration. The small molecule targets proteins that senescent cells rely on for survival. The company is supporting initiation of a Phase IIa proof-of-concept study in DME to evaluate the safety and efficacy of UBX1325. Initial data from this Phase IIa study is expected in the first half of 2022.
Further product details are provided in the report……..
Diabetic macular edema: Therapeutic Assessment
This segment of the report provides insights about the different Diabetic macular edema drugs segregated based on following parameters that define the scope of the report, such as:
• Major Players in Diabetic macular edema
There are approx. 50+ key companies which are developing the therapies for Diabetic macular edema. The companies which have their Diabetic macular edema drug candidates in the most advanced stage, i.e. Phase III include, Mylan Pharmaceuticals.
DelveInsight’s report covers around 50+ 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 macular edema pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
• Molecule Type
Products have been categorized under various Molecule types such as
• Monoclonal Antibody
• Small molecule
• Gene therapy
• Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
Diabetic macular edema: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Diabetic macular edema 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 macular edema drugs.
Diabetic macular edema Report Insights
• Diabetic macular edema Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs
Diabetic macular edema Report Assessment
• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs
Current Treatment Scenario and Emerging Therapies:
• How many companies are developing Diabetic macular edema drugs?
• How many Diabetic macular edema drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Diabetic macular edema?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Diabetic macular edema 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 macular edema and their status?
• What are the key designations that have been granted to the emerging drugs?
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