PUBLISHER: DelveInsight | PRODUCT CODE: 1425966
PUBLISHER: DelveInsight | PRODUCT CODE: 1425966
DelveInsight's "Retinal Vein Occlusion (RVO) - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of retinal vein occlusion, historical and forecasted epidemiology, as well as the retinal vein occlusion market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The Retinal vein occlusion market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM retinal vein occlusion market size from 2020 to 2034. The report also covers retinal vein occlusion treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2020-2034
Retinal vein occlusion Overview
Retinal vein occlusion, the second most common sight-threatening retinal vascular disorder after diabetic retinopathy, is characterized by blockage of the small veins that carry blood away from the retina. A degenerative disease often initiated by atherosclerosis and the formation of a blood clot, it is characterized by sudden vision change. However, the degree of vision change depends on the severity and location of the blockage. With blockage, pressure builds up in the capillaries, leading to hemorrhage and leakage of fluid and blood; this can lead to macular edema with leakage near the macula.
Retinal vein occlusion diagnosis
The initial examination of a patient with a retinal vein occlusion includes all relevant aspects of the comprehensive adult medical eye evaluation, with particular attention to those aspects related to retinal vascular disease. Several tests are being used for the diagnosis such as optical coherence tomography (OCT), and fluorescein angiography (FA). Apart from this, systemic evaluation is often performed in patients with CRVO and is directed by the patient's age, coexisting risk factors, and medical history. Optical coherence tomography angiography (OCTA) provides a non-invasive way to assess the extent of impaired capillary perfusion in retinal vascular occlusion without injection of contrast dye. Fundus autofluorescence can be perceived, in patients with recent-onset CRVO, a perivenular hypo autofluorescence with a fern-like appearance.
Further details related to country-based variations are provided in the report…
Retinal vein occlusion treatment
The main goal of the treatment is to stabilize vision by sealing off leaking blood vessels and to manage complications of macular edema and neovascularization. Response to treatment is measured by improvement of visual acuity (as a measure of photoreceptor status) and retinal thickness (as a measure of leakage. The current treatment regime for retinal vein occlusion includes the use of anti-VEGFs, corticosteroids, laser therapy, and several other off-labeled therapies.
Unfortunately, no treatment can reverse retinal vein occlusion, though attempts have been made to create anastomoses through surgery and laser, to relieve the obstruction through thrombolytic administration and bypass the congestion via optic nerve sheathotomy.
Currently, few products are approved by the US FDA for the treatment of retinal vein occlusion, which includes LUCENTIS (ranibizumab, Roche/Novartis), EYLEA (aflibercept, Regeneron Pharmaceutical/Bayer/Santen), OZURDEX (dexamethasone intravitreal implant, AbbVie), besides the recently approved VABYSMO (faricimab, Roche/Chugai Pharmaceutical). AVASTIN (bevacizumab) and intravitreal triamcinolone are used as off-label therapies that help in maintaining or improving vision.
As the market is derived using a patient-based model, the retinal vein occlusion epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of retinal vein occlusion, total diagnosed prevalent cases of retinal vein occlusion, gender-specific diagnosed prevalent cases of retinal vein occlusion, age-specific diagnosed prevalent cases of retinal vein occlusion, and type-specific diagnosed prevalent cases of retinal vein occlusion in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
Among the 7MM, the US accounted for nearly 61% of the total diagnosed prevalent cases of retinal vein occlusion, with nearly 935,343 cases in 2022. These cases are expected to increase during the study period (2020-2034).
According to estimates based on DelveInsight's epidemiology model, retinal vein occlusion exhibits a higher female preponderance than males in the US. Of the total diagnosed prevalent cases in the US, nearly 48% were males and 52% were females, in 2022.
The drug chapter segment of the retinal vein occlusion report encloses a detailed analysis of retinal vein occlusion-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the retinal vein occlusion clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Marketed Drugs
VABYSMO (faricimab): Roche/Chugai Pharmaceutical
VABYSMO (faricimab) is a humanized bispecific immunoglobulin G1 (IgG1) antibody that binds both vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2). The fragment crystallizable (Fc) region of faricimab was engineered by selected point mutations to abolish binding interactions with Fc? and FcRn receptors. Faricimab is a humanized bispecific antibody that acts through the inhibition of two pathways by binding to VEGF-A and Ang-2. By inhibiting VEGF-A, faricimab suppresses endothelial cell proliferation, neovascularization, and vascular permeability. By inhibiting Ang-2, faricimab is thought to promote vascular stability and desensitize blood vessels to the effects of VEGF-A. In October 2023, the US FDA approved VABYSMO (faricimab) for the treatment of macular edema following retinal vein occlusion.
Note: Further marketed drugs and their details will be provided in the report…
Emerging Drugs
Tarcocimab tedromer (KSI-301): Kodiak Sciences
Tarcocimab tedromer (KSI-301), an intravitreal injection being developed by Kodiak Sciences, is a novel anti-VEGF biologic designed to have an extended ocular half-life. It consists of a custom-built antibody inhibiting VEGF, a potent cytokine known to contribute to the pathology of retinal vascular diseases, conjugated with a phosphorylcholine biopolymer. The drug is designed to maintain potent and effective drug levels in ocular tissues for longer than the existing agents and is based on the antibody biopolymer conjugate platform.
Kodiak Sciences has completed the Phase III BEACON study of KSI-301 in individuals with visual impairment due to treatment-naive macular edema secondary to retinal vein occlusion and plans to conduct one additional pivotal study in the first half of 2024, which, if successful, will serve as the basis for a BLA for macular edema following retinal vein occlusion.
LYTENAVA (bevacizumab)/ONS-5010: Outlook Therapeutics
LYTENAVA (bevacizumab)/ONS-5010 is an investigational ophthalmic formulation of bevacizumab to be administered as an intravitreal injection. Bevacizumab is a recombinant humanized monoclonal antibody that selectively binds with high affinity to all isoforms of human VEGF and neutralizes VEGF's biological activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells.
Outlook Therapeutics has completed a Phase III trial to evaluate the safety of ophthalmic bevacizumab in subjects diagnosed with BRVO and is conducting another Phase III trial to compare the safety of ophthalmic bevacizumab in vials versus prefilled syringes in subjects with BRVO. Besides this, Outlook Therapeutics intends to initiate NORSE FOUR, a registration clinical trial that will evaluate ONS-5010 for use in treating BRVO. Further, the company has received agreement from the FDA on the protocols for NORSE FOUR.
Note: Further emerging therapies and their detailed assessment will be provided in the final report.
Drug Class Insights
The mainstay treatment for retinal vein occlusion includes intravitreal injection of anti-VEGF drugs. These drugs target VEGF, an important growth factor that causes macular edema. Anti-VEGF drugs are markedly more effective in the treatment of retinal vein occlusion than any other treatment modality. Among all the available treatment choices, anti-VEGF drugs provide the greatest improvement in VA.
LUCENTIS (ranibizumab), developed by Roche and marketed by Novartis and Chugai Pharmaceuticals in North America and Japan, respectively, is a VEGF inhibitor. Ranibizumab binds to the receptor-binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF110. VEGF-A causes neovascularization and leakage in models of ocular angiogenesis and vascular occlusion and contributes to the pathophysiology of wet AMD, mCNV, DR, DME, and macular edema following retinal vein occlusion. The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.
Recently in 2023, VABYSMO, a faricimab, developed by Roche and Chugai with CrossMab technology targets two distinct pathways. Faricimab is a humanized bispecific antibody that acts through the inhibition of two pathways by binding to VEGF-A and Ang-2. By inhibiting VEGF-A, faricimab suppresses endothelial cell proliferation, neovascularization, and vascular permeability. By inhibiting Ang-2, faricimab is thought to promote vascular stability and desensitize blood vessels to the effects of VEGF-A. Ang-2 levels are increased in some patients with nAMD, DME, and retinal vein occlusion.
Retinal vein occlusion is a common vascular disorder of the retina and one of the most common causes of vision loss worldwide. It is the second most common cause of blindness from retinal vascular disease after diabetic retinopathy. There is no treatment available to reverse retinal vein occlusion. Most people with this condition will have permanent changes to their vision. The main goal of the treatment should be to stabilize vision by sealing off leaking blood vessels.
Unfortunately, there is no way actually to unblock retinal veins. However, the doctor can treat any health problems that seem to be related to retinal vein occlusion. Vision may come back in some eyes that have had a retinal vein occlusion. About one-third have some improvement, about one-third stay the same, and about one-third gradually improve, but it can take a year or more to learn the outcome. In some cases, the blocked vessels will lead to fluid accumulation in the retina while in others, may cause the formation of new blood vessels.
Currently, there are only few FDA-approved products for retinal vein occlusion treatment, which include LUCENTIS (ranibizumab, Roche/Novartis), EYLEA (aflibercept, Regeneron Pharmaceutical/Bayer/Santen), OZURDEX (dexamethasone intravitreal implant, AbbVie), and the recently US FDA approved VABYSMO (faricimab, Roche/Chugai Pharmaceutical). While AVASTIN (bevacizumab) and intravitreal triamcinolone are used as an off-label therapy that helps in maintaining or improving vision.
Various therapies are being developed and the pipeline for retinal vein occlusion includes therapies like Kodiak Sciences' tarcocimab tedromer (KSI-301), Outlook Therapeutics' LYTENAVA (bevacizumab)/ONS-5010, Taiwan Liposome Company's TLC399 (ProDex), Alcon's AR-1105 (dexamethasone implant), and others.
Continued in report…
The current market segmentation is based on the therapies prescribed and is further sub-segment based on the mechanism of action and their usage. The drugs that are being used in the present market include LUCENTIS (ranibizumab), EYLEA (aflibercept), and AVASTIN (bevacizumab), besides other therapies like OZURDEX (dexamethasone intravitreal implant) and intravitreal triamcinolone, etc. Even the recently US FDA-approved VABYSMO (faricimab) is included. These are the major segments covered in the forecast model.
Several key players are evaluating their lead candidates in different stages of clinical development like tarcocimab tedromer (KSI-301) and LYTENAVA (bevacizumab)/ONS-5010. They aim to investigate their products to treat macular edema secondary to retinal vein occlusion and BRVO, respectively.
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. For example, Outlook Therapeutics' LYTENAVA (bevacizumab)/ONS-5010, an investigational ophthalmic formulation of bevacizumab, is projected to be the first and only FDA-approved, on-label, responsibly priced bevacizumab, with a slow-medium uptake, will enter the US market in 2027.
Further detailed analysis of emerging therapies drug uptake in the report…
Retinal Vein Occlusion Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
Pipeline development activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for retinal vein occlusion.
KOL Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on retinal vein occlusion evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the Royal College of Ophthalmologists, Johns Hopkins University School of Medicine, Charite University Medicine Berlin, Italian College of General Practitioners, University of Leicester, and the Kanagawa Children's Medical Center were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or retinal vein occlusion market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Physician's View
According to our primary research analysis, various anti-VEGF therapies, are available in the market and prescribed. Anti-VEGF drugs are markedly more effective in the treatment of retinal vein occlusion than any other treatment modality. Among all the available treatment choices, anti-VEGF drugs provide the greatest improvement in visual acuity. The current treatment choices for retinal vein occlusion include anti-VEGF drugs, corticosteroids, laser therapy, and others. The anti-VEGF drugs include AVASTIN (bevacizumab), LUCENTIS (ranibizumab), EYLEA (aflibercept), and the recently US FDA-approved VABYSMO (faricimab), for the treatment of retinal vein occlusion. Among these LUCENTIS, and EYLEA have been approved in the US, EU4 the UK, and Japan, but VABYSMO is still not approved in Europe and Japan, while bevacizumab is being used off-label in all countries.
According to a KOL in the US, anti-VEGF injection burden and frequency are lower, and visual outcomes are poorer in the real-world, tertiary care practice setting than in clinical trials that evaluate the monthly administration of injections, which reflects the presence of under treatment outside the controlled trial setting.
As per another KOL, an efficient treatment approach for addressing the underlying etiology of macular edema in retinal vein occlusion is a therapy that suppresses VEGF. As a result, intravitreal anti-VEGF treatment has become the norm for treating this condition. The therapy can improve vision, but patients with significant retinal damage due to impaired blood flow often have poor outcomes.
Another KOL in Germany found that patient characteristics were similar for patients receiving ranibizumab or aflibercept at index. The disease is typically more prevalent in older, hypertensive, and cardiovascular disease individuals and its prevalence increases with age. BRVO is four times more prevalent than CRVO
The current pipeline contains stem cell therapies, tyrosine kinase inhibitors, and several small molecules that target different pathways in retinal vein occlusion. The entry of these drugs will provide different options relating to patient-specific needs based on the type of occlusion and associated edema.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance improvement in best-corrected visual acuity (BCVA) and ocular central subfield thickness (CST), and others.
Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
Reimbursement of rare disease therapies can be limited due to lack of supporting policies and funding, challenges of high prices, lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers' concerns about budget impact. The high cost of rare disease drugs usually has a limited effect on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies in recent years. From a patient perspective, health insurance and payer coverage guidelines surrounding rare disease treatments restrict broad access to these treatments, leaving only a small number of patients who can bypass insurance and pay for products independently.
The reimbursement challenges related to medical care and treatment for individuals with retinal vein occlusion can be significant as it often requires specialized medical attention, covering the costs of diagnosis, treatment, and ongoing care. Health insurance plans may not fully cover limited coverage of some medical treatments, therapies, and devices specific to retinal vein occlusion. This can result in high out-of-pocket expenses for families seeking the best care for their loved ones. Moreover, it requires specialized care from healthcare providers with expertise. Finding and accessing such specialists may be challenging, and the associated costs may not always be fully reimbursed by insurance.
Further details will be provided in the report.
The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Retinal vein occlusion report insights
Retinal vein occlusion report key strengths
Retinal vein occlusion report assessment
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies