DUBLIN–(BUSINESS WIRE)–The “Diabetic Macular Edema – Pipeline Insight, 2021” clinical trials has been added to ResearchAndMarkets.com’s offering.
This Diabetic macular edema – Pipeline Insight, 2021 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.
Report Highlights
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-naive 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.
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.
Phases
This 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
- Oral
- Parenteral
- Intravenous
- Subcutaneous
- Topical
- Molecule Type
Products have been categorized under various Molecule types such as
- Monoclonal Antibody
- Peptides
- Polymer
- Small molecule
- Gene therapy
- Product Type
The 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
Companies Mentioned
- Adverum Biotechnologies
- Aerie Pharmaceuticals
- Aerpio Therapeutics
- Allergo Ophthalmics
- Ampio Pharmaceuticals
- Arctic Vision
- AsclepiX Therapeutics
- Bio-Thera Solutions
- Boehringer Ingelheim
- Celltrion
- Clearside Biomedical
- Curacle Co., Ltd.
- Exonate Limited
- GlaxoSmithKline
- Graybug Vision
- Hoffman-La-Roche
- KalVista Pharmaceuticals
- Kodiak Sciences Inc
- MingSight Pharmaceuticals
- Mylan Pharmaceuticals
- Novartis
- Ocugen Inc.,
- Oculis Pharma
- Ocuphire Pharma, Inc.
- Oxurion
- Regeneron pharmaceuticals
- RemeGen
- Rezolute
- Ripple Therapeutics
- SciFluor Life Sciences, Inc.
- Sunshine Guojian Pharmaceutical
- ThromboGenics
- Unity Biotechnology
- Verseon
- YD Global Life Science
For more information about this clinical trials report visit https://www.researchandmarkets.com/r/yee20j
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