Diabetic Macular Edema Pipeline

DelveInsight’s, “Diabetic Macular Edema - Pipeline Insight, 2025” report provides comprehensive insights about 45+ 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.

 

Geography Covered

• Global coverage

 

Diabetic Macular Edema: Understanding

Diabetic Macular Edema: Overview

Diabetic macular edema (DME) is a common complication of diabetes that affects the macula, the central part of the retina responsible for sharp, detailed vision. It occurs when high blood sugar levels damage blood vessels in the retina, causing fluid leakage and swelling, leading to visual impairment. DME is one of the leading causes of blindness in adults, particularly in the United States. Early detection and treatment are crucial to prevent irreversible vision loss, with anti-vascular endothelial growth factor (VEGF) therapy currently being the standard of care. However, ongoing research is focused on developing new and more effective treatment options.

 

The exact cause of diabetic macular edema (DME) remains complex and multifactorial, with several factors contributing to its development. One key factor is the accumulation of advanced glycation end products (AGEs) due to prolonged hyperglycemia in diabetes. AGEs are osmotically active and may contribute to fluid leakage and retention in the macula. Additionally, diabetes disrupts the blood-retinal barrier (BRB), allowing for the leakage of fluid and inflammatory mediators into the retina, which plays a critical role in DME pathogenesis. Furthermore, AGEs are linked to increased inflammatory markers such as vascular endothelial growth factor (VEGF), leukocyte adhesion, and protein kinase C, all of which exacerbate retinal damage and the development of edema.

 

The pathophysiology of diabetic macular edema (DME) is primarily driven by the disruption of the blood-retinal barrier (BRB), which separates the retina's photoreceptors from the surrounding blood vessels. The BRB consists of two major compartments—outer and inner barriers—that work together to maintain retinal homeostasis. In diabetes, both compartments' permeability is compromised, allowing fluid, proteins, and inflammatory mediators to leak into the macula, leading to edema. This disruption is further exacerbated by elevated levels of advanced glycation end products (AGEs) and hyperglycemia, which trigger inflammatory responses and increase the expression of vascular endothelial growth factor (VEGF). VEGF contributes to macular edema by promoting blood vessel leakage and stimulating abnormal blood vessel growth (vasculogenesis), which worsens retinal damage and disease progression.

 

The treatment of diabetic macular edema (DME) has evolved significantly over the years. Historically, laser photocoagulation was a cornerstone of therapy, particularly for treating leaking microaneurysms. The Early Treatment Diabetic Retinopathy Study (ETDRS) established guidelines for laser therapy, with focal and scatter laser photocoagulation recommended for specific cases of non-proliferative and proliferative diabetic retinopathy. While laser therapy has been effective in improving visual acuity in a small subset of patients, it is not curative, and many cases do not respond to this approach. Vitrectomy surgery has also shown some benefit in DME, though the mechanisms remain unclear. In recent years, however, the treatment landscape has shifted toward anti-vascular endothelial growth factor (anti-VEGF) therapy, which has become the current first-line approach. Other emerging treatments include subthreshold micropulse photocoagulation and intravitreal steroid injections, offering additional options to manage the condition more effectively and prevent vision loss.

 

"Diabetic Macular Edema- Pipeline Insight, 2025" 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.

 

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 III, 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

• OCS-01: Oculis 

OCS-01 is an innovative high concentration eye drop candidate to treat DME. It is developed with the proprietary OPTIREACH® technology to enable drug passage from the anterior to the posterior segment of the eye following topical application, a route of administration that contrasts with currently available DME therapies, all requiring invasive delivery to reach the retina, such as ocular implants or intravitreal injections. The OPTIREACH® solubilizing formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface and thereby enabling the drug passage from the eye surface to the posterior segment of the eye. Currently, the drug is in Phase III stage of its development for the treatment of Diabetic Macular Edema.

 

• 4D-150: 4D Molecular Therapeutics

4D-150 combines the customized and evolved intravitreal vector, R100, and a transgene cassette that expresses both aflibercept and a VEGF-C inhibitory RNAi. This dual-transgene payload inhibits four members of the VEGF angiogenic family of factors that drive wet AMD and DME: VEGF A, B, C and PlGF. R100 was invented at 4DMT through the proprietary Therapeutic Vector Evolution platform. 4D-150 is designed for single, low-dose intravitreal delivery for transgene expression from the retina without significant inflammation. Currently, the drug is in Phase II stage of its development for the treatment of Diabetic Macular Edema.

 

• D-4517.2: Ashvattha Therapeutics

D-4517.2 is a potent anti-angiogenic nanomedicine (“dendranib”) that crosses the blood-retinal barrier and selectively targets activated microglia, macrophages and retinal pigment epithelial cells in the eye. D-4517.2 has the potential to change the current treatment paradigm for neovascular age-related macular degeneration (wet AMD) and diabetic macular edema (DME) by offering an at-home dosing option by a subcutaneous route of administration rather than delivery via intravitreal injection (injection into the eye). Currently, the drug is in Phase II stage of its development for the treatment of Diabetic Macular Edema.

 

• OCU200: Ocugen

OCU200 is a biologic product candidate in development for treating severely sight-threatening diseases like diabetic macular edema (DME), diabetic retinopathy (DR), and wet age-related macular degeneration (Wet-AMD). OCU200 is a novel fusion protein consisting of two human proteins, tumstatin and transferrin, that are already present in retinal tissues. OCU200 has unique features, which enable it to efficiently target leaky blood vessels, regress the existing abnormal blood vessels, and inhibit the growth of new blood vessels in the retina and choroid. Tumstatin, which acts as an anti-VEGF, anti-inflammatory, and anti-oxidative agent, is the active component of OCU200. It binds to integrin receptors, which play a crucial role in disease pathogenesis. Transferrin facilitates the targeted delivery of tumstatin into the retina and choroid and potentially helps increase the interaction between tumstatin and integrin receptors. Currently, the drug is in Phase I stage of its development for the treatment of Diabetic Macular Edema.

 

• AIV007: AiViva BioPharma, Inc.

AIV007 is a novel formulation using JEL™ Technology designed for prolonged drug release. AIV007 targets multiple pathways including VEGFR, PDGFR, and FGFR to address neovascularization and fibrosis, and it also modulates TGFβ1 mRNA expression and TGFβ1 levels to reduce collagen production and scarring. In nonclinical in vivo studies for nAMD, AIV007 demonstrated safety, efficacy, and prolonged treatment duration with a single intravitreal administration. Ocular safety and effects in the reduction of neovascularization and fibrosis were observed in several nonclinical animal models and patients. Currently, the drug is in Phase I stage of its development for the treatment of Diabetic Macular Edema.

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. 45+ 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, Oculis.

 

Phases

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 

• 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 Macular Edema: Pipeline Development Activities 

The report provides insights into different therapeutic candidates in Phase III, 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

 

Key Questions

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?