What is the Retinal Vein Occlusion Market?
What is the Retinal Vein Occlusion Market?
DelveInsight’s ‘Retinal vein occlusion Market Insights, Epidemiology, and Market Forecast–2032’ report delivers an in-depth understanding of the Retinal vein occlusion, historical and forecasted epidemiology as well as the Retinal vein occlusion market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
What is the Retinal vein occlusion Market Size Report?
The Retinal vein occlusion market report provides current treatment practices, emerging drugs, market share of the individual therapies, and current and forecasted 7MM Retinal vein occlusion market size from 2019 to 2032. The Report also covers current Retinal vein occlusion treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
What is the Retinal vein occlusion Overview?
Retinal vein occlusion is one of the most frequently occurring retinal vascular disorders in elderly patients that develop predominantly in individuals over the age of 65 years. The main risk factor for Retinal vein occlusion includes age. With the increase of the geriatric population, as of now, the prevalence of retinal vein occlusion is also supposed to be on the high rise. Further risk factors include systemic conditions like hypertension, arteriosclerosis, diabetes mellitus, hyperlipidemia, cerebral vascular stroke, blood hyperviscosity, and thrombophilia. A strong risk factor for Retinal vein occlusion is metabolic syndrome (hypertension, diabetes mellitus, and hyperlipidemia). Individuals with end-organ damage caused by diabetes mellitus and hypertension have a substantially increased risk for retinal vein occlusion. Ophthalmic risk factors for Retinal vein occlusion are ocular hypertension and glaucoma, higher ocular perfusion pressure, and changes in the retinal arteries.
What is the Retinal vein occlusion Treatment Market?
The current market for Retinal vein occlusion is dependent on the use of anti-VEGF, corticosteroids, laser therapy, and several other off-labeled therapies. Among the present treatment option, anti-VEGF occupies the maximum market share. Current treatment within Retinal vein occlusion is aimed at the secondary outcome i.e., macular edema Retinal vein occlusion. Anti-VEGF drugs have proven efficacy in the treatment of retinal vein occlusion, hence are used most. Anti-VEGF drugs make the injured blood vessels less leaky, thereby decreasing macular edema. The anti-VEGF molecules that are being used in the present market include ranibizumab, aflibercept, and bevacizumab. Aflibercept and ranibizumab are anti-VEGF drugs approved by the US FDA for the treatment of Retinal vein occlusion-associated macular edema.
Bevacizumab is the FDA-approved biologic for treating cancer but is frequently used off-label to treat conditions of the eye, including CRVO. Bevacizumab is a less expensive anti-VEGF drug as compared to aflibercept, hence is used mostly as off-labeled therapy. Among corticosteroid therapy, Ozurdex is used mostly in Retinal vein occlusion management. In June 2009, the US FDA approved it for the treatment of macular edema following BRVO or CRVO. It represents the first injectable, sustained-release, potent steroid implant that provides prolonged efficacy and a favorable safety profile.
What are the Retinal vein occlusion Marketed Drugs?
Lucentis (ranibizumab): Roche
Lucentis developed by Roche is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use which binds to and inhibits the biological activity of human VEGF-A. It binds with high affinity to the VEGF-A isoforms (e.g. VEGF110, VEGF121, and VEGF165), thereby preventing the binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2. VEGF-A is a protein that has a critical role in angiogenesis and the hyperpermeability of the vessels.
The drug is a prescription medication given by injection into the eye. It has been associated with a detached retina and serious eye infection and should not be used in patients who have an infection in or around the eye. It was first approved by the US FDA for the treatment of wet-AMD in 2006. Besides Retinal vein occlusion it is also approved for diabetic macular edema, diabetic retinopathy in patients with diabetic macular edema, and myopic choroidal neovascularization
Ozurdex (dexamethasone): AbbVie
Ozurdex developed by Allergan (now acquired by AbbVie) is the first injectable, sustained-release, potent steroid implant with a prolonged efficacy and a favorable safety profile. It is a dissolving implant that is injected directly into the vitreous humor of the eye to treat swelling that may occur when there is a blockage of certain blood vessels in the eyes. Ozurdex contains dexamethasone in the Novadur solid polymer sustained-release drug delivery system and is preloaded into a single-use, DDS applicator to facilitate direct injection of the implant into the vitreous. The Novadur system contains poly (D, L-lactide-co-glycolide) PLGA intravitreal polymer matrix without any preservative. It is also approved for the treatment of non-infectious posterior uveitis and diabetic macular edema.
What are the Retinal vein occlusion Emerging Drugs?
KSI-301: Kodiak Sciences
KSI-301, an intravitreal injection being developed by Kodiak Sciences Inc., 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 (ABC) Platform. Kodiak Sciences is currently conducting a Phase III BEACON study of KSI-301 in individuals with macular edema due to treatment-naïve Retinal vein occlusion. These studies are anticipated to form the basis of the company's initial BLA to support potential approval and commercialization. The results of the BEACON study are anticipated to be announced in 2022.
Vabysmo (faricimab): Roche/Chugai Pharmaceuticals
Vabysmo (faricimab) being developed by Roche is a bispecific antibody developed with CrossMab technology to tightly bind VEGF-A on one arm and angiopoietin (Ang)-2 on the other arm, targeting two distinct pathways that drive several retinal conditions. Ang-2 and VEGF-A contribute to vision loss by destabilizing blood vessels, causing new leaky blood vessels to form and increasing inflammation. 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. Therefore by simultaneously blocking both pathways involving Ang-2 and VEGF-A, faricimab stabilizes blood vessels, potentially improving vision outcomes for longer for people living with retinal conditions. Roche is currently conducting Phase III trials to evaluate the efficacy and safety of Faricimab in patients with macular edema secondary to BRVO and CRVO and based on its results is expected to file for approval by 2023.
TLC399 (ProDex): Taiwan Liposome Company
TLC399 is a multilamellar and multivesicular proprietary BioSeizer formulation of dexamethasone sodium phosphate (DSP), intended as an intravitreal, or in-eye, injection for the treatment of macular edema due to retinal vein occlusion. TLC399 in preclinical models has been shown to provide therapeutic levels of DSP in the eye for at least 6 months after a single administration and has also demonstrated its potential to decrease the thickness of the retina and improve vision. TLC399 through its sustained release technology will provide benefits for a much longer duration at reduced administration frequency. In the phase, I/II safety trial the formulation demonstrated an effective reduction in retinal central subfield thickness and improvements in visual acuity. Successful Phase II trial results were published and a further update is awaited. The company is also evaluating the opportunities to develop TLC399 in diabetic macular edema in combination with intravitreal anti-VEGF drugs.
What is the Retinal vein occlusion Market Outlook?
The current treatment options for Retinal vein occlusion intend to minimize the damage, as there is no treatment to improve vision loss in the long term. The therapies aim to prevent further visual loss and its complications, such as macular edema, ischemia, or neovascularization. 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. Intravitreal injection of corticosteroid drugs is to combat inflammation and edema. Intraocular injections of steroids are another potential treatment for eyes that do not respond to anti-VEGF drugs. While intraocular steroids can have some side effects such as an increase in eye pressure and cataract progression, in most cases, these side effects can be controlled.
Laser treatment may be used along with anti-VEGF therapy in hard-to-treat cases. Laser therapy for macular edema involves applying light laser pulses to the macula in a grid pattern. Pan-retinal photocoagulation therapy is a treatment option used when patients have new blood vessel formation following the Retinal vein occlusion. While Focal laser therapy is used to treat associated edema. Several other treatment strategies focus on the surgical treatment of the occluded retinal vein. Some of the approaches include radial optic neurotomy, chorioretinal venous anastomosis, vitrectomy with or without internal limiting membrane peeling, and others.
Currently, there are only three FDA-approved products for Retinal vein occlusion treatment, including Lucentis (ranibizumab, Roche), Eylea (aflibercept, Regeneron), Ozurdex (dexamethasone intravitreal implant, AbbVie) while Avastin (bevacizumab) and intravitreal triamcinolone are used as an off-label therapy that help in maintaining or improving the vision.
Apart from the approved and off-label therapies, various emerging therapies are being evaluated in clinical trials for the treatment of Retinal vein occlusion and its types. The emerging therapies include ONS-5010/Lytenava (Outlook Therapeutics), KSI-301 (Kodiak Sciences), TLC399/ProDex (Taiwan Liposome Company), AR-1105 (Aerie Pharmaceuticals), and GB-102 (Graybug Vision), and Vabysmo (faricimab/RG7716) (Roche/ Chugai Pharmaceutical). However, most of these are being developed for associated complications of macular edema secondary to Retinal vein occlusion except ONS-5010/Lytenava. Also, most in the pipeline have anti-VEGF agonist mechanisms of action or are corticosteroids, and hence they will be competing with the other already approved therapies of this type. However, Roche’s Vabysmo (faricimab/RG7716) targeting two distinct pathways and with expected approval by 2024 may get an early mover advantage over others in the category.
Get to know more about the key players of the report @ Retinal Vein Occlusion Market Companies
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