Proliferative Diabetic Retinopathy - Pipeline Insight, 2025

This “Proliferative Diabetic Retinopathy- Pipeline Insight, 2025” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Proliferative 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.

Proliferative Diabetic Retinopathy: Understanding

Proliferative Diabetic Retinopathy: Overview

Proliferative Diabetic Retinopathy (PDR) is a severe, vision-threatening complication of diabetes mellitus characterized by the proliferation of new blood vessels on the retina and the posterior surface of the vitreous. This neovascularization occurs in response to retinal ischemia, where reduced blood supply leads to the production of angiogenic factors like vascular endothelial growth factor (VEGF). If left untreated, PDR can result in severe vision loss or blindness due to complications such as vitreous hemorrhage, tractional retinal detachment, and neovascular glaucoma.

The signs and symptoms of PDR include floaters, blurred vision, and sudden loss of vision, which are often the result of vitreous hemorrhage. In advanced cases, patients may experience scotomas (blind spots) and severe vision impairment. Clinical examination may reveal neovascularization of the optic disc (NVD) or elsewhere on the retina (NVE), along with pre-retinal hemorrhages and fibrous tissue proliferation. These signs are typically detected through a dilated fundus examination and confirmed with imaging techniques such as fluorescein angiography and optical coherence tomography (OCT).

The primary cause of PDR is long-standing, poorly controlled diabetes, which leads to chronic hyperglycemia. Chronic hyperglycemia damages the retinal microvasculature, resulting in capillary occlusion and subsequent retinal ischemia. The ischemic retina releases VEGF and other growth factors, stimulating the formation of fragile new blood vessels. These vessels can leak or bleed, causing vitreous hemorrhage and fibrovascular proliferation, which can contract and cause retinal detachment.

Pathophysiologically, PDR represents the final stage of diabetic retinopathy, following non-proliferative diabetic retinopathy (NPDR). The progression from NPDR to PDR involves worsening capillary occlusion, increased retinal ischemia, and the upregulation of angiogenic stimuli. This pathological neovascularization is the hallmark of PDR, distinguishing it from earlier stages of diabetic retinopathy. The new vessels' fragility and propensity to bleed lead to the primary vision-threatening complications of the disease.

Diagnosis of PDR involves comprehensive eye examinations, including visual acuity testing, dilated fundus examination, and imaging studies such as fluorescein angiography, which highlights areas of retinal ischemia and neovascularization, and OCT, which provides detailed cross-sectional images of the retina. Treatment options for PDR aim to reduce retinal ischemia and inhibit neovascularization. The mainstay treatments include pan-retinal photocoagulation (PRP) laser therapy, which destroys ischemic retinal tissue and reduces VEGF production, and intravitreal injections of anti-VEGF agents like bevacizumab, ranibizumab, or aflibercept, which directly inhibit the action of VEGF. In advanced cases with significant vitreous hemorrhage or retinal detachment, vitrectomy surgery may be necessary to restore vision and repair retinal structures.

'Proliferative Diabetic Retinopathy- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Proliferative Diabetic Retinopathy pipeline landscape is provided which includes the disease overview and Proliferative Diabetic Retinopathy treatment guidelines. The assessment part of the report embraces, in depth Proliferative 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, Proliferative 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 Proliferative Diabetic Retinopathy R&D. The therapies under development are focused on novel approaches to treat/improve Proliferative Diabetic Retinopathy.

Proliferative Diabetic Retinopathy Emerging Drugs Chapters

This segment of the Proliferative 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.

Proliferative Diabetic Retinopathy Emerging Drugs

APX3330: Ocuphire Pharma, Inc.

APX3330, is a first-in-class small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein). Ref-1 is a regulator of transcription factors such as HIF-1a and NF-kB. Inhibiting REF-1 reduces levels of vascular endothelial growth factor (“VEGF”) and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. Through inhibition of Ref-1, APX3330 normalizes the levels of VEGF to physiologic levels, unlike biologics that deplete VEGF below the levels required for normal function. APX3330 is an oral tablet administered twice per day for the treatment of diabetic retinopathy. A Phase II study in subjects with DR and an End-of-Phase II meeting have recently been completed, and a Special Protocol Assessment is planned to be submitted with the U.S. Food and Drug Administration (FDA). Currently, the drug is in Phase II stage of its development for the treatment of diabetic retinopathy.

OTT166: OcuTerra Therapeutics, Inc.

Nesvategrast (OTT166) is an investigational, novel, patented, potent and selective small molecule RGD integrin inhibitor designed with purpose engineering to have an optimum balance of physiochemical properties to allow it to distribute to the retina in high concentrations after topical (eye drop) administration to the eye. In preclinical studies, nesvategrast selectively inhibited key RGD integrin subtypes, including αvβ3, to regulate cellular responses to VEGF and other growth factors known to contribute to development and progression of diabetic retinopathy and other ocular diseases. In early clinical trials in patients with diabetic retinal disease, nesvategrast eye drops have demonstrated preliminary evidence of tolerability and biological activity. Currently, the drug is in Phase II stage of its development for the treatment of diabetic retinopathy.

Proliferative Diabetic Retinopathy: Therapeutic Assessment

This segment of the report provides insights about the different Proliferative Diabetic Retinopathy drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Proliferative Diabetic Retinopathy

• There are approx. 5+ key companies which are developing the therapies for Proliferative Diabetic Retinopathy. The companies which have their Proliferative Diabetic Retinopathy drug candidates in the most advanced stage, i.e. phase II include, Ocuphire Pharma, Inc.

Phases

The report covers around 5+ 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

Proliferative 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.

Proliferative Diabetic Retinopathy: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Proliferative 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 Proliferative Diabetic Retinopathy drugs.

Proliferative Diabetic Retinopathy Report Insights

• Proliferative Diabetic Retinopathy Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Proliferative 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 Proliferative Diabetic Retinopathy drugs?
• How many Proliferative 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 Proliferative Diabetic Retinopathy?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Proliferative 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 Proliferative Diabetic Retinopathy and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Apexian Pharmaceuticals
• OcuTerra Therapeutics, Inc.

Valo Health, Inc.

Kubota Vision Inc.

RemeGen Co., Ltd.

Key Products

• APX 3330
• OTT166
• OPL-0401
• Emixustat hydrochloride
• RC-28E

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