The "Diabetic Macular Edema - Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.

This ''Diabetic Macular Edema - Pipeline Insight, 2022" report provides comprehensive insights about 65+ companies and 65+ 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.

The report 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.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence R&D Diabetic Macular Edema. The therapies under development are focused on novel approaches to treat/improve Diabetic Macular Edema.
• In November 2021, MingSight completed a New Round of Financing to accelerate clinical development in Chronic Lymphocytic Leukemia and Diabetic Macular Edema. MingSight Pharmaceuticals closed $20m a pre-Series B round, led by Kaitai Capital. The proceeds will be used for the clinical development of MS-553, a new generation inhibitor of protein kinase C (PKC) beta for the treatment of Chronic lymphocytic Leukemia (CLL) and Diabetic Macular Edema (DME).
• In July 2021, Ascentage Pharma announced that its global licensee, UNITY Biotechnology reported encouraging data from a Phase I clinical study of UBX1325, an investigational Bcl-xL inhibiting compound, in patients with certain advanced vascular eye diseases, and has already dosed the first patient in the subsequent Phase IIa clinical study. According to the terms of the licensing agreement previously entered into between Ascentage Pharma and UNITY, this progress in clinical development will qualify Ascentage Pharma for a milestone payment in the amount of US$2 million, which will be paid in UNITY common stock.
• In January 2020, Ocuphire Pharma entered into an agreement with Apexian Pharmaceuticals, Inc., granting Ocuphire an exclusive worldwide sublicense to Apexian's Ref-1 Inhibitor program, including its lead drug candidate APX3330, for all ophthalmic and diabetic indications.

Diabetic Macular Edema Drugs

KSI-301: Kodiak Sciences

KSI-301 is an investigational anti-VEGF therapy built on Kodiak's Antibody Biopolymer Conjugate (ABC) Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing available agents. Kodiak's objective with KSI-301 is to develop a new first-line agent to improve outcomes for patients with retinal vascular diseases and to enable earlier treatment and prevention of vision loss for patients with diabetic eye disease. The KSI-301 clinical program is designed to assess KSI-301's durability, efficacy and safety in wet AMD, DME, RVO and non-proliferative DR (without DME) through clinical studies run in parallel

UBX 1325: Ascentage Pharma

UBX1325 is a small-molecule inhibitor of Bcl-xL, and the first senolytic therapeutic clinically evaluated in an ophthalmological setting. UBX1325 is designed to inhibit the function of proteins that senescent cells rely on for survival and could potentially provide a valuable alternative or adjunctive treatment option to anti-VEGF therapies. Phase I study that evaluated the safety of UBX1325 in patients with advanced diabetic macular edema (DME) or wet age-related macular degeneration (wet AMD) for whom anti-VEGF therapy was no longer considered beneficial, the majority of patients with DME or wet AMD treated with a single injection of UBX1325 achieved rapid improvement in key outcome measures. In terms of tolerability and safety, UBX1325 was shown to be well-tolerated with no treatment-related adverse events or dose-limiting toxicities. Furthermore, the first patient has already been dosed in a Phase IIa clinical study assessing the safety and efficacy of UBX1325 in a broader population of patients with DME

RZ402: Rezolute

RZ402 is a selective and potent plasma kallikrein inhibitor (PKI) being developed as a potential oral therapy for the chronic treatment of diabetic macular edema (DME). By inhibiting the formation of kallikrein, RZ402 is designed to block downstream bradykinin production and the pro-inflammatory, pro-coagulant, and fluid-leakage contact-activation cascade. RZ402-101 is a first-in-human Phase 1a, single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy adult volunteers. The study objectives were to characterize the safety profile and pharmacokinetics of RZ402 administered as single oral doses. The study enrolled 30 subjects in three planned sequential dose-level cohorts of 25 mg, 100 mg, and 250 mg. Single doses of RZ402 resulted in dose-dependent increases in systemic exposure. Currently, the product is in Phase II for DME.

APX3330: Ocuphire Pharma

APX3330, a novel, first-in-class, twice-daily oral tablet drug candidate, specifically targets Apurinic/Apyrimidinic Endonuclease 1/Redox Effector Factor-1 (APE1/Ref-1) protein, referred to as Ref-1. APX3330 has a dual mechanism of action in validated pathways, decreasing both abnormal angiogenesis and inflammation by blocking pathways downstream of Ref-1. APX3330 specifically blocks Ref-1's redox signaling function leading to simultaneous decreases in the activity of several important proangiogenic and proinflammatory transcription factors relevant to the pathophysiology of retinal and choroidal vascular diseases: HIF-1a to reduce VEGF signaling and NF-kB to modulate VEGF, TNF-? and other inflammatory cytokines.

APX3330 is currently being developed for diabetic retinopathy (DR) and diabetic macular edema (DME).

THR-687: Oxurion

THR-687 is a potential best-in-class small molecule pan-RGD integrin antagonist being developed for the treatment of DME and holding promise for the treatment of wet Age-related Macular Degeneration (wAMD) and macular edema following Retinal Vein Occlusion (RVO). The INTEGRAL trial is a two-part Phase 2, randomized, multi-center clinical trial and is the first trial in which multiple intravitreal injections of THR-687 will be administered in humans.

MS-553: MingSight Pharmaceuticals

MS-553 is an investigational drug candidate and a new generation PKC beta inhibitor. It differentiates from the previous generation of pan-PKC inhibitors with its novel chemotype and significant advantages in selectivity, safety, and PK properties. MS-553 has the unique PK property of preferential distribution to the retina and its mechanism of action addresses both the aberrant VEGF signaling and the inflammation that are characteristics of DME. MS-553 also has the potential, if approved, to become the first oral DME therapy with anti-VEGF like efficacy. MS-553 also demonstrated clinical activities including reduction of retinal thickness and improvement of visual acuity in a phase 1b trial of DME patients. MS-553 is a potentially the only B-cell receptor inhibitor in clinical development that can address the BTK resistant mutations in both BTK and PLCG2.

ADVM-022: Adverum Biotechnologies

ADVM-022 utilizes a propriety vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. ADVM-022 (AAV.7m8-aflibercept) is administered as a single, in-office intravitreal (IVT) injection, designed to deliver long-term efficacy, reduce the burden of frequent anti-VEGF injections, and improve vision outcomes for patients with wet age-related macular degeneration (wet AMD).

Diabetic Macular Edema: Therapeutic Assessment

This segment of the report provides insights about the 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. 65+ key companies which are developing the therapies Diabetic Macular Edema. The companies which have their Diabetic Macular Edema drug candidates in the most advanced stage, i.e. phase III include, Vitaris.

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.

Key Questions Answered

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?

Key Players

• Mabwell (Shanghai) Bioscience
• Kala Pharmaceuticals
• Galapagos NV
• Viatris
• Kodiak Sciences
• Novartis
• Celltrion
• Ascentage Pharma
• Adverum Biotechnologies
• Aerie Pharmaceuticals
• Allegro Ophthalmics
• Ampio Pharmaceuticals
• Arctic Vision
• AsclepiX Therapeutics
• Bio-Thera Solutions
• CURACLE
• GlaxoSmithKline
• Roche
• KalVista Pharmaceuticals
• GrayBug Vision
• MingSight Pharmaceuticals
• Ocugen
• Oculis Pharma
• Ocuphire Pharma
• Verseon
• YD Global Life Science
• Regeneron Pharmaceuticals
• Rezolute
• Ripple Therapeutics
• Roche
• KalVista Pharmaceuticals
• RemeGen
• Rezolute
• Ripple Therapeutics
• SciFluor Life Sciences
• ThromboGenics
• UNITY Biotechnology

Key Products

• Aflibercept biosimilar
• THR 687
• MYL-1701P
• KSI-301
• Brolucizumab
• CT-P42
• UBX1325
• ADVM-022
• AR-1105
• ALG-1001
• Danazol
• XIPERE
• AXT-107
• BAT 5906
• CU 06
• GSK2798745
• Susvimo
• KVD 001
• GB-102
• MS 553
• OCU200
• OCS-01
• APX3330
• UBX1967
• UBX1325
• VE 3539
• Imatinib mesylate
• Aflibercept
• RZ402
• IBE-814
• Faricimab
• RC28
• RZ402
• IBE-814
• SF-0166
• THR-317
• UBX 2050

For more information about this clinical trials report visit https://www.researchandmarkets.com/r/oghdrq

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