Age-Related Vision Dysfunction - Market Insights, Epidemiology, and Market Forecast - 2030

This ‘Age-related Vision Dysfunction - Market Insights, Epidemiology, and Market Forecast - 2030’ report delivers an in-depth understanding of the Age-related Vision Dysfunction, historical and forecasted epidemiology as well as the Age-related Vision Dysfunction market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

The Age-related Vision Dysfunction market report provides current treatment practices, emerging drugs, Age-related Vision Dysfunction market share of the individual therapies, current and forecasted Age-related Vision Dysfunction market size from 2018 to 2030 segmented by seven major markets. The Report also covers current Age-related Vision Dysfunction treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2018–2030

Age-related Vision Dysfunction: Disease Understanding and Treatment Algorithm

Age-related Vision Dysfunction Overview

The International Classification of Diseases 11 (2018) classifies vision impairment into two groups, distance and near presenting vision impairment. Beginning in the early to mid-forties, most adults may start to experience problems with their ability to see clearly at close distances, especially for reading and computer tasks. This normal change in the eye’s focusing ability will continue to progress over time. Vision loss among the elderly population is a major health care problem. Approximately one in three people have some form of vision-reducing eye disease by the age of 65. Beginning in the early to mid-forties, most adults may start to experience problems with their ability to see clearly at close distances, especially for reading and computer tasks. This normal change in the eye’s focusing ability will continue to progress over time. Adults over 40 may be particularly at risk for the development of eye and vision problems.

The process of aging contributes to visual loss through the deterioration of the function of the eye tissues and increased ocular pathology in the elderly. The process of pathology takes place over months to years, and patients usually have minimal symptoms initially. The five major causes of visual impairment in the elderly are presbyopia, age-related cataracts, age-related macular degeneration (AMD), glaucoma, and diabetic retinopathy.

Aging changes in various parts of the eye can result in several noticeable differences in how well a person can see. While not everyone will experience the same level of symptoms, the following are common age-related vision changes, some of the common symptoms include difficulty reading and doing close work, problems with glare, changes in color perception, reduced tear production, seeing distorted images, loss of side vision, seeing floaters and flashes, and fluctuating vision.

Age-related Vision Dysfunction Diagnosis

The comprehensive adult eye and vision examination provides the means to evaluate the function and health of the eyes and visual system and to obtain information to diagnose the cause of signs noted by the examiner or symptoms reported by the patient. It also provides the means to identify the presence of other ocular or systemic conditions that may exist without symptoms.

The diagnostic tests for the various vision diseases caused by old age include tests such as visual acuity tests, Fundus Fluorescein Angiography (FFA), Indocyanine green angiography (ICG), Amsler Grid Test, Visual Field Test, and Tonometry Test, among others.

Age-related Vision Dysfunction Treatment

Current clinical management of presbyopia in the United States includes off-label treatment using miotic agents, such as pilocarpine and carbachol. Pharmacological treatment of presbyopia is based on using ophthalmic drops, which by the impact on the ciliary muscle, changes the pupil size and elasticity, improving near vision. Many different modifications, including the combination of two parasympathomimetics and an NSAID, two parasympathomimetics and one parasympatholytic, carbachol 2.25% with brimonidine 0.2%, and a combination of pilocarpine 0.247%, phenylephrine 0.78%, polyethylene glycol 0.09%, nepafenac 0.023%, pheniramine 0.034%, and naphazoline 0.003% were studied.

The most common and effective clinical treatment for wet AMD is anti-VEGF therapy which is periodic intravitreal (into the eye) injection. The various forms of anti-VEGF injections include ranibizumab, bevacizumab, and the US FDA also approved aflibercept. Each of these chemicals works in a different way to inhibit blood vessel growth. Recently, new anti-VEGF treatments that do not need to be injected into the eye as often as Eylea, Lucentis, or Avastin have been approved, which includes Novartis’ new drug, Beovu. Also currently, there are different gene therapy candidates under investigation for wet AMD and dry AMD. In Europe, three anti-VEGF drugs are available for nAMD and have made dramatic improvements in patients' lives. Bevacizumab and ranibizumab are labeled for monthly intravitreal injections and aflibercept is labeled for bimonthly intravitreal. In Japan, the Anti-VEGF drug is usually used in nAMD treatment, and its intravitreal administration has become the first-line treatment. In Japan, pegaptanib, ranibizumab, and aflibercept are anti-VEGF drugs currently approved by the Ministry of Health, Labor, and Welfare (MHLW).

Cataract treatment consists of both non-surgical methods of improving symptoms of vision deterioration as well as surgical removal of the cataract. Early cataract symptoms may be improved with new eyeglasses, anti-glare sunglasses, or magnifying lenses.

Initial treatment of Glaucoma aims at reducing the IOP. The pharmacological therapies used are topical beta-blockers (such as timolol) in reducing aqueous production. If further reduction of IOP is necessary, other drugs such as epinephrine, miotics, carbonic anhydrase inhibitors, alpha2 agonists, and prostaglandin analogs are added in a stepwise pattern. In Japan, the most frequently prescribed antiglaucoma medications are prostaglandin analogs (PGs); however, in recent years, fixed combination therapy has emerged as a major treatment.

The treatment of Diabetic Retinopathy (DR) is dependent on the severity of the disease, with DR classified into non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR). In Japan, anti-VEGF is the first line of treatment for DR. Although intravitreal injections of steroids are as effective as anti-VEGF drugs in resolving DR, these are no longer commonly performed in Japan. In the US, Bevacizumab was the first available angiogenesis inhibitor. Other anti-VEGF medicines, such as aflibercept (Eylea) or ranibizumab (Lucentis) are also approved for the treatment of DR. Patients with mild to moderate NPDR without DME are typically managed with systemic control only, while pan-retinal photocoagulation (PRP) has been the standard of care for patients with PDR.

Overall, currently, several types of medications are being used in the management of age-related vision dysfunction, including anti-VEGF agents, anti-inflammatory agents, mitotic or cholinergic agents, prostaglandins, beta-blockers, alpha-adrenergic agonists, and rho-kinase inhibitors. Nonpharmacologic treatments for age-related vision dysfunctions can include surgeries, eye laser treatment, corneal inlays, lens implants, photodynamic therapy (PDT), and other treatments. There are several approved drugs for the treatment of age-related vision dysfunction such as Rhopressa/Rhokiinsa (Netarsudil mesylate), Vyzulta (Latanoprostene Bunod Ophthalmic Solution), Glanatec (Ripasudil hydrochloride hydrate), Tapcom/DE-111 (Tafluprost/ Timolol Maleate; Taptiqom), Combigan (Brimonidine/timolol), Rocklatan/Roclanda (Latanoprast; Netarsudil Dimesylate), Eybelis Ophthalmic Solution (DE-117, Omidenepag isopropyl), Xelpros (Latanoprost Ophthalmic Emulsion), Simbrinza (Brinzolamide/Brimonidine Tartrate Ophthalmic Suspension), Azarga/Azorga (Brinzolamide/Timolol), Lucentis (Ranibizumab), Eylea (Aflibercept), Beovu (Brolucizumab), among others.

Age-related Vision Dysfunction Epidemiology

The Age-related Vision Dysfunction epidemiology division provides insights about historical and current Age-related Vision Dysfunction patient pool and forecasted trends for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings

In the year 2020, the total prevalent case of Age-related Vision Dysfunction was 374,306,439 cases in the 7MM which are expected to grow during the study period, i.e. 2018–2030.

The disease epidemiology covered in the report provides historical as well as forecasted Age-related Vision Dysfunction epidemiology [segmented as Total Prevalent Cases of Age-related Vision Dysfunction, Total Diagnosed Cases of Age-related Vision Dysfunction, Severity-specific Cases of Age-related Vision Dysfunction, and Treated cases of Age-related Vision Dysfunction] in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2018 to 2030.

Country Wise- Age-related Vision Dysfunction Epidemiology

Estimates show that the highest cases of Age-related Vision Dysfunction in the 7MM were in the United States, followed by Japan, Germany, Italy, France, the United Kingdom, and Spain in 2020.
In the United States, the total number of prevalent cases of Age-related Vision Dysfunction was 159,952,427 cases in the year 2020 which are expected to grow during the study period, i.e., 2018–2030.
In the year 2020, the total prevalent cases of Age-related Vision Dysfunction were 168,408,889 cases in EU-5 which are expected to grow during the study period, i.e., 2018–2030.
In Japan, the total number of prevalent cases of Age-related Vision Dysfunction was 45,945,123 cases in the year 2020 which are expected to grow during the study period, i.e., 2018–2030.

Age-related Vision Dysfunction Drug Chapters

The drug chapter segment of the Age-related Vision Dysfunction report encloses the detailed analysis of Age-related Vision Dysfunction marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Age-related Vision Dysfunction 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.

Age-related Vision Dysfunction Approved Drugs

Rhopressa/Rhokiinsa/ Netarsudil mesylate (Aerie Pharmaceuticals)

Rhopressa/Rhokiinsa (Netarsudil mesylate) is a Rho kinase inhibitor. Intended for topical application in the eye, each mL of Rhopressa contains 0.2 mg of netarsudil (equivalent to 0.28 mg of netarsudil dimesylate). Rhopressa works differently as compared to other eye pressure-reducing medications to provide consistent pressure lowering. It is a ROCK inhibitor that lowers IOP by targeting the trabecular meshwork to increase aqueous humor outflow and decrease episcleral venous pressure (EVP). In December 2017, the US FDA approved Rhopressa 0.02% for the lowering of elevated IOP in patients with open-angle glaucoma or ocular hypertension. Later, in November 2019, the European Commission (EC) granted marketing authorization for Rhokiinsa 0.02% for the reduction of elevated IOP in adult patients with primary open-angle glaucoma or ocular hypertension.

Rocklatan/Latanoprast and Netarsudil Dimesylate (Aerie Pharmaceuticals)

Rocklatan/Roclanda (netarsudil and latanoprost ophthalmic solution) is a 0.02%/0.005% fixed-dose combination of a Rho kinase inhibitor and a prostaglandin F2α analog indicated for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. Rocklatan is comprised of two components: netarsudil and latanoprost. Each of these two components decreases elevated IOP. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and glaucomatous visual field loss. In March 2019, the US FDA approved Rocklatan 0.02%/0.005% for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. In January 2021, the EC granted marketing authorization for Roclanda 0.02%/0.005% for the reduction of elevated IOP in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with prostaglandin or netarsudil provides insufficient IOP reduction.

Xelpros/Latanoprost (Sun Pharma Advanced Research Company Limited)

Xelpros is a novel, BAK-free Latanoprost Ophthalmic Emulsion developed with Lipixelle Technology. Prostaglandin analogs such as Latanoprost are the first-line treatment for open-angle glaucoma or ocular hypertension and form the largest drug class. BAK is a common preservative in topical ocular preparations; however, prolonged use may lead to deleterious effects on the ocular surface, affecting the quality of life and reducing adherence to treatment and overall outcomes. In September 2018, the US FDA approved the NDA of Xelpros 0.005% for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension.

Lucentis/Ranibizumab (Genentech and Novartis)

Lucentis (Ranibizumab), a VEGF inhibitor, is indicated for the treatment of patients with Neovascular (Wet) AMD and DR in patients with DME. 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 has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion and is thought to contribute to the pathophysiology of neovascular AMD and DR. 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. The company retains commercial rights in the US, and Novartis has exclusive commercial rights for the rest of the world. The US FDA first approved ranibizumab in June 2006, for the treatment of neovascular wet AMD. The US FDA approved Lucentis after a Priority Review (six-month). The EMA first approved ranibizumab in January 2007, for the treatment of Wet-AMD. The Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) first approved ranibizumab in January 2009, for the treatment of Wet-AMD. In August 2012, Lucentis was approved by the US FDA for treatment of DME.

Eylea/Aflibercept (Bayer, Regeneron Pharmaceuticals, and Santen)

Eylea (Aflibercept) is a VEGF inhibitor indicated for the treatment of patients with Neovascular (Wet) AMD, DME, and DR. Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. It was co-developed and co-marketed as Eylea by Regeneron and Bayer (also marketed by Santen in Japan). In November 2011, the US FDA approved Eylea (aflibercept) to treat patients with wet (neovascular) AMD. In May 2019, the US FDA approved Eylea (aflibercept) injection for treating all stages of DR, thereby reducing the risk of blindness. In June 2014, a committee of the EMA recommended market approval for aflibercept to treat visual impairment caused by DME. The PMDA first approved aflibercept in September 2012, for the treatment of Wet-AMD.

Vyzulta/Latanoprostene Bunod Ophthalmic Solution (Bausch & Lomb and Nicox)

Vyzulta (latanoprostene bunod ophthalmic solution), 0.024% is a prostaglandin analog formulated as a sterile topical ophthalmic solution. It is a prescription eye drop that is used to lower IOP in patients with open-angle glaucoma or ocular hypertension. Vyzulta helps lower eye pressure by increasing the drainage of fluid from the eye. Latanoprostene bunod is thought to lower IOP by increasing the outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. In November 2017, the US FDA approved the NDA for Vyzulta for patients with open-angle glaucoma or ocular hypertension.

Note: Detailed Current therapies assessment will be provided in the full report of Age-related Vision Dysfunction

Age-related Vision Dysfunction Emerging Drugs

AGN-190584 (Allergan [acquired by AbbVie])

AbbVie’s Allergan is developing, AGN-190584 an investigational optimized formulation of pilocarpine. It is a cholinergic muscarinic receptor agonist that is being investigated for treating symptoms associated with presbyopia as a topical, once-daily drop delivered by a proprietary vehicle. The proposed mechanism of action of AGN-190584 is through dynamic pupil modulation, an effect in which the iris sphincter is contracted to achieve pupil size reduction in an optimal range. The goal of this pupil size reduction is to increase the depth of focus. Secondarily, it is believed to allow for increased accommodation through mild contraction of the ciliary muscle. Recently, AGN-190584 has completed two Phase III (NCT03857542 and NCT03804268) trials. The purpose of these studies was to evaluate AGN-190584 in the participant population and expanded participant population to establish efficacy, safety, and tolerability versus the vehicle-control when administered, over a 30-day study intervention period, once-daily bilaterally in participants with presbyopia.

Faricimab (Hoffman La Roche)

Faricimab is the first investigational bispecific antibody designed for the eye with CrossMab technology. It targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) – 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 increase inflammation. By simultaneously blocking both pathways involving Ang-2 and VEGF-A, faricimab is designed to stabilize blood vessels, potentially improving vision outcomes for longer for people living with retinal conditions. It is being developed to target Diabetic Macular Edema, Wet AMD, and other retinal disorders. It has already been evaluated and is in process for the above-mentioned indications.

PresbiDrops/CSF-1 (Orasis Pharmaceuticals)

PresbiDrops (CSF-1) is a corrective eye drop being developed for offering an alternative to reading glasses and intrusive surgical procedures to enhance the quality of life for people with presbyopia. Delivered directly to the eyes as a topical solution, CSF-1 provides a patented blend of current and well-studied ingredients with the potential for close vision restoration in people with presbyopia. CSF-1 is designed to be convenient and on-demand. Important increases in close vision and a superior safety profile have been seen in clinical trial reports to date, supporting possible improvements in the quality of life in people with presbyopia. CSF-1 is designed to be not only efficient but also safe comfortable, convenient, and easy-to-use by repurposing existing and well-studied molecules that have been researched for many years. It is also being developed to improve near visual acuity by pupil modulation, resulting in a “pinhole effect” and an increase in the depth of field, thus increasing the ability to focus on near objects. CSF-1 is currently under investigation in two Phase III trials (NCT04599933 (NEAR-1)) (NCT04599972 (NEAR-2)).

RGX-314 (Regenxbio)

RGX-314 is being developed by Regenxbio, as a probable one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions. RGX-314 consists of the NAV AAV8 vector, which encodes an antibody fragment designed to inhibit VEGF. RGX-314 is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina. Regenxbio is advancing two separate routes of administration of RGX-314 to the eye, through a standardized subretinal delivery procedure as well as delivery to the suprachoroidal space. REGENXBIO has licensed certain exclusive rights to the SCS Microinjector from Clearside Biomedical, Inc. to deliver gene therapy treatments to the suprachoroidal space of the eye.

MicroLine/Pilocarpine Ophthalmic (Eyenovia)

MicroLine is Eyenovia's patented pilocarpine presbyopia formulation. In ophthalmology, pilocarpine is a well-characterized drug, with several trials showing its ability to improve the depth of focus of the eye to reverse the age-related loss of accommodative effect and enhance close vision. The use of presbyopia pilocarpine as an eye drop may be limited because of the potential for side effects associated with the dosage, as well as the inconvenience and inconsistency of typical eyedropper dosing. Pilocarpine works by creating a Pinhole effect, which is done by the constricting of the pupil of the eye, similar to a pinhole camera, and brings near and medium-distance objects into focus. This mechanism of action is very commonly used in contact lenses and surgical approaches for improvement in near vision in patients with presbyopia. Now, with MicroLine, Eyenovia is trying to build an approach that can improve near vision with this micro-dosed drug.

KSI-301 (Kodiak Sciences)

KSI-301 is an investigational anti-VEGF therapy built on the Kodiak's Antibody Biopolymer Conjugate (ABC) Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing 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 company is developing KSI-301 to be the only generation 2.0 anti-VEGF biologic agent, intending to provide patients, physicians, and health systems with a new first-line agent for wet AMD, DME, RVO, and DR. KSI-301 is a novel anti-VEGF biologic designed to rapidly inhibit VEGF and provide extended durability of action to reduce the burden of frequent anti-VEGF injections. Delivering potent and sustained VEGF inhibition enables patient compliance, results in long-term efficacy, and improves visual acuity outcomes.

Note: Detailed emerging therapies assessment will be provided in the final report.

Age-related Vision Dysfunction Market Outlook

Visual impairment among the elderly population is a major health problem. With advancing age, the normal function of eye tissues decreases. Age-related vision changes occur to many people as they grow older. Some problems arise from new or worsening vision disorders. As a person gets older, these changes might happen gradually. The most common causes of age-related visual impairment in the elderly are presbyopia, cataracts, AMD, primary open-angle glaucoma, and DR, among others. Visual impairment problems in elderly people could hamper daily activities enormously.

Currently, several types of medications are being used in the management of age-related vision dysfunction, including anti-VEGF agents, anti-inflammatory agents, mitotic or cholinergic agents, prostaglandins, beta-blockers, alpha-adrenergic agonists, and rho-kinase inhibitors. Nonpharmacologic treatments for age-related vision dysfunctions can include surgeries, eye laser treatment, corneal inlays, lens implants, photodynamic therapy (PDT), and other treatments.

There are several approved drugs for the treatment of age-related vision dysfunction such as Rhopressa/Rhokiinsa (Netarsudil mesylate), Vyzulta (Latanoprostene Bunod Ophthalmic Solution), Glanatec (Ripasudil hydrochloride hydrate), Tapcom/DE-111 (Tafluprost/ Timolol Maleate; Taptiqom), Combigan (Brimonidine/timolol), Rocklatan/Roclanda (Latanoprast; Netarsudil Dimesylate), Eybelis Ophthalmic Solution (DE-117, Omidenepag isopropyl), Xelpros (Latanoprost Ophthalmic Emulsion), Simbrinza (Brinzolamide/Brimonidine Tartrate Ophthalmic Suspension), Azarga/Azorga (Brinzolamide/Timolol), Lucentis (Ranibizumab), Eylea (Aflibercept), Beovu (Brolucizumab), among others.

Still, there are some unmet needs in the age-related vision dysfunction market. There are several instances where pathophysiological knowledge and, as a result, treatment options are lacking. More successful and well-tolerated therapies are needed. Different formulation modes and/or novel anti-inflammatory/ immunomodulation agents may be used to accomplish this. Also, the late occurrence of symptoms in all the mentioned ophthalmologic conditions drives the diagnosis paradigm negatively. Additionally, the effects of anti-VEGF on retinal ischemia are unclear.

Major ocular adverse effects of anti-VEGF intravitreal injections, such as IOP rise, are transient but may be relevant in patients with glaucoma. Serious adverse effects such as endophthalmitis are rare but accumulate with continuous injections. Nevertheless, recently some developmental initiatives have been taken towards the management of age-related vision dysfunction. Several pharmaceutical key players have taken to the initiative to meet the unmet needs of the present situation of age-related vision dysfunction. Some of the key players are in the late and mid clinical development stages with their leading drug candidates.

Key players such as Hoffman La Roche (Faricimab), Eyenovia (MicroLine), Allergan (AbbVie) and Molecular Therapeutics (Abicipar), Regenxbio (RGX-314), Novartis (Brolucizumab), Santen (STN1013001 /DE-130A), Nicox Ophthalmics (NCX 470), Kodiak Sciences (KSI-301), Opthea Limited (OPT-302), Ocular Therapeutix (OTX-TP), Allergan (acquired by AbbVie) (AGN-190584), Orasis Pharmaceuticals (PresbiDrops), IVERIC bio (Zimura), Alkeus Pharmaceuticals (ALK 001), Outlook Therapeutics (ONS-5010/LYTENAVA), Sun Pharma Advanced Research Company Limited (PDP – 716) and several others are investigating their candidates for the management of age-related vision dysfunction in the 7MM.

Key Findings

The Age-related Vision Dysfunction market size in the 7MM is expected to change during the study period 2018–2030. The therapeutic market of Age-related Vision Dysfunction in the seven major markets is expected to increase during the study period (2018–2030) with a CAGR of 3.4%. According to the estimates, the highest market size of Age-related Vision Dysfunction is found in the United States followed by Germany.

The United States Market Outlook

The total market size of Age-related Vision Dysfunction therapies in the United States is expected to increase with a CAGR of 5.4% in the study period (2018–2030).

EU-5 Countries: Market Outlook

The total market size of Age-related Vision Dysfunction therapies in EU-5 countries is expected to increase with a CAGR of 1.8% in the study period (2018–2030).

Japan Market Outlook

The total market size of Age-related Vision Dysfunction therapies in Japan is expected to increase with a CAGR of 0.8% in the study period (2018–2030).

Age-related Vision Dysfunction Pipeline Development Activities

The drugs which are in pipeline include:

1. AGN-190584 (Allergan [acquired by AbbVie])
2. MicroLine/Pilocarpine Ophthalmic (Eyenovia)
3. PresbiDrops/CSF-1 (Orasis Pharmaceuticals)
4. Zimura/ Avacincaptad pegol (IVERIC Bio)
5. ALK-001 (Alkeus Pharmaceuticals)
6. ONS-5010/Lytenava/Bevacizumab-vikg (Outlook Therapeutics)
7. KSI-301 (Kodiak Sciences)
8. Faricimab (Roche)
9. Abicipar (Allergan [acquired by AbbVie]/Molecular Partners)
10. RGX-314 (Regenxbio)
11. Beovu/RTH258/Brolucizumab (Novartis)
12. STN1013001/DE-130A/Catioprost and latanoprost emulsion (Santen SAS)
13. NCX 470 (Nicox Ophthalmics)
14. OTX-TP/Travoprost ophthalmic insert (Ocular Therapeutix)
15. PDP-716 (Sun Pharma Advanced Research Company Limited)
16. OPT-302 (Opthea)
17. Lumitin/Conbercept (Chengdu Kanghong Pharmaceuticals)
18. AKST4290/Lazucirnon (Alkahest)
19. GT005 (Gyroscope Therapeutics)
20. ADVM-022 (Adverum Biotechnologies)
21. Emixustat hydrochloride (Kubota Vision)
22. KVD001 (KalVista Pharmaceuticals)
23. Luminate/ALG-1001/Risuteganib (Allergo Opthalmics and Baush Health)
24. GB-102 (Graybug Vision)
25. Razuprotafib/AKB-9778 (Aerpio Pharmaceuticals)
26. Nyxol/Phentolamine Mesylate (Ocuphire Pharma)
27. STN1012600/DE-126 (Santen Pharmaceutical)

Note: Detailed emerging therapies assessment will be provided in the final report.

Analyst Commentary

The growth of the age-related vision dysfunction market is expected to be mainly driven by the increasing prevalence of vision dysfunction cases due to increase in the geriatric population, rise in awareness and access to treatment, alternative options (such as a novel therapeutic agent) to anti-VEGF treatment, upsurge in the launch of products with readily adoption and lifestyle changes.

In wet age-related macular degeneration (Wet-AMD) and diabetic retinopathy, the market is mainly dominated by anti-VEGF therapies like aflibercept, ranibizumab, and bevacizumab (used as off-label). Due to the entry of biosimilars and expected competition from emerging therapies, the revenue from these three drugs is expected to decline in the 7MM.

Among the emerging therapies, AGN-190584 (pilocarpine 1.25%) is expected to generate the maximum revenue owing to the largest presbyopia patient pool, early mover advantage, dosing advantage (i.e. once daily), and visibility around the phase III results.

In indications like presbyopia and cataract, no pharmacological treatment has been approved and physicians and patients are still waiting for safe and effective treatment options for this huge patient pool.

Access and Reimbursement Scenario in Age-related Vision Dysfunction Therapies

Eylea (Aflibercept) has received mixed opinion and also with some conditional usage from the HTA bodies for the usage in AMD. NICE has recommended aflibercept as an option for treating wet AMD only if it is used in accordance with the recommendations for ranibizumab. Germany HTA body IQWiG has not accepted for wet age-related macular degeneration as there is “No proof of the added benefit of aflibercept than the ACT specified by the G-BA could be derived from the data presented. Hence there are no patient groups for whom a therapeutically important added benefit could be derived.” However in case of France, as per HAS, the actual benefit of aflibercept is substantial in the treatment of exudative retrofoveolar AMD. Positive reimbursement decision (65%) in inpatient and outpatient settings.

As per the organization, NICE, evidence on the efficacy of miniature lens system implantation for advanced AMD shows that the procedure can improve both vision and quality of life in the short term. Data on short-term safety are available for limited numbers of patients. There is currently insufficient long-term evidence on both efficacy and safety. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Whereas Brolucizumab is recommended as an option for treating wet AMD in adults, only if, in the eye to be treated- the best-corrected visual acuity is between 6/12 and 6/96, there is no permanent structural damage to the central fovea, the lesion size is less than or equal to 12 disc areas in the greatest linear dimension, or there is recent presumed disease progression.

HAS has a favorable opinion for Latanoprost in the reduction of elevated intraocular pressure (IOP) in pediatric patients with elevated IOP and suffering from glaucoma. As per the organization, important clinical benefit, no improvement in actual benefit (ASMR V).

Rhopressa got approval in Europe as well in the year 2019. Formulary contracts for commercial insurance coverage in 2018 and Medicare Part D program coverage in 2019 had been executed, and now rhopressa is a part of the Medicare Part D program. Part D prescription drug coverage is an optional benefit offered to all Medicare recipients. Enrollment requires joining a plan that is approved by Medicare. Choices include a Medicare Prescription Drug Plan (PDP) added to Original Medicare or a Medicare Advantage Plan that includes prescription drug coverage. Regardless of the option taken, recipients must live in the service area of the plan they join. Costs and specific drugs covered vary.

Besides, through the availability of a co-pay savings card program, all patients covered by commercial insurance will have immediate access to Rhopressa. The most common version of Rhopressa is covered by 73% of insurance plans at a co-pay of USD 60.00–USD 80.00. Due to a recent formulary change in the United States, Medicare Part D coverage of Vyzulta increased in the United States from nearly 30% to 45% in 2020. Vyzulta is indicated in the United States to reduce IOP in patients with open-angle glaucoma or ocular hypertension.

Note: Detailed HTA assessment will be provided in the final report.

KOL-Views

To keep up with current market trends, we take KOLs and SME’s opinions working in the Age-related Vision Dysfunction domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Age-related Vision Dysfunction market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

The publisher performs a Competitive and Market Intelligence analysis of the Age-related Vision Dysfunction Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Age-related Vision Dysfunction, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies.
• Comprehensive insight has been provided into the Age-related Vision Dysfunction epidemiology and treatment in the 7MM.
• Additionally, an all-inclusive account of both the current and emerging therapies for Age-related Vision Dysfunction is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Age-related Vision Dysfunction market; historical and forecasted is included in the report, covering drug outreach in the 7MM.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Age-related Vision Dysfunction market.

Report Highlights

In the coming years, the Age-related Vision Dysfunction market is set to change due to the rising awareness of the disease and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.

The companies and academics are working to assess challenges and seek opportunities that could influence Age-related Vision Dysfunction R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.

Major players are involved in developing therapies for Age-related Vision Dysfunction. The launch of emerging therapies will significantly impact the Age-related Vision Dysfunction market.

A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Age-related Vision Dysfunction.

The in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Age-related Vision Dysfunction Report Insights

• Patient Population
• Therapeutic Approaches
• Age-related Vision Dysfunction Pipeline Analysis
• Age-related Vision Dysfunction Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies
• Age-related Vision Dysfunction Report Key Strengths
• 10 Years Forecast
• 7MM Coverage
• Age-related Vision Dysfunction Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake
• Age-related Vision Dysfunction Report Assessment
• SWOT Analysis
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers

Key Questions

Market Insights:

• What was the Age-related Vision Dysfunction Market share (%) distribution in 2018 and how it would look like in 2030?
• What would be the Age-related Vision Dysfunction total market size as well as market size by therapies across the 7MM during the study period (2018–2030)?
• What are the key findings of the market across the 7MM and which country will have the largest Age-related Vision Dysfunction market size during the study period (2018–2030)?
• At what CAGR, the Age-related Vision Dysfunction market is expected to grow in the 7MM during the study period (2018–2030)?
• What would be the Age-related Vision Dysfunction market outlook across the 7MM during the study period (2018–2030)?
• What would be the Age-related Vision Dysfunction market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• Age-related Vision Dysfunction patient types/pool where unmet need is more and whether emerging therapies will be able to address the residual unmet need?
• How emerging therapies are performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration, and frequencies based on their clinical trial results?
• Among the emerging therapies, what are the potential therapies which are expected to disrupt the Age-related Vision Dysfunction market?

Epidemiology Insights:

• What are the disease risks, burdens, and unmet needs of Age-related Vision Dysfunction?
• What is the historical Age-related Vision Dysfunction patient pool in the seven major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What would be the forecasted patient pool of Age-related Vision Dysfunction in the 7 major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What will be the growth opportunities in the 7MM concerning the patient population about Age-related Vision Dysfunction?
• Out of all the 7MM countries, which country would have the highest prevalent population of Age-related Vision Dysfunction during the study period (2018–2030)?
• At what CAGR the population is expected to grow in the 7MM during the study period (2018–2030)?
• What are the various recent and upcoming events which are expected to improve the diagnosis of Age-related Vision Dysfunction?

Current Treatment Scenario and Emerging Therapies:

• What are the current options for the treatment of Age-related Vision Dysfunction?
• What are the current treatment guidelines for the treatment of Age-related Vision Dysfunction in the US, Europe, and Japan?
• How many companies are developing therapies for the treatment of Age-related Vision Dysfunction?
• How many therapies are developed by each company for the treatment of Age-related Vision Dysfunction?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Age-related Vision Dysfunction?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Age-related Vision Dysfunction therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Age-related Vision Dysfunction and their status?
• What are the key designations that have been granted for the emerging therapies for Age-related Vision Dysfunction?
• What is the global historical and forecasted market of Age-related Vision Dysfunction?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving the Age-related Vision Dysfunction market.
• To understand the future market competition in the Age-related Vision Dysfunction market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Age-related Vision Dysfunction in the US, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Age-related Vision Dysfunction market.
• To understand the future market competition in the Age-related Vision Dysfunction market.