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 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 F2a 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.