presbyopia market insight

DelveInsight’s ‘Presbyopia - Market Insights, Epidemiology, and Market Forecast—2030’ report deliver an in-depth understanding of Presbyopia, historical and forecasted epidemiology as well as Presbyopia market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

The Presbyopia market report provides current treatment practices, emerging drugs, Presbyopia market share of the individual therapies, current and forecasted Presbyopia market size from 2018 to 2030 segmented by seven major markets. The Report also covers current Presbyopia 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

Presbyopia: Disease Understanding and Treatment Algorithm

Presbyopia Overview

Presbyopia, a natural age-related condition, is the result of a gradual decrease in accommodative amplitude, from about 15 diopters (D) in early childhood to 1 D before the age of 60 years. An irreversible, normal physiologic condition that affects all primates, it impairs the ability to see clearly at near. It is a natural part of aging. Presbyopia usually becomes noticeable in the early to mid-40s and continues to worsen until around age 65. Presbyopia can be classified by type which includes incipient presbyopia, functional presbyopia, absolute presbyopia, premature presbyopia, and nocturnal presbyopia. Presbyopia is partly due to age-related changes in the proteins within the lens of the eye that cause it to become thicker, harder, and less flexible. This loss of flexibility affects the lens's ability to refract light rays which, in turn, affects the eye's capacity to focus.

Initial symptoms may be difficulties with prolonged close-up work, with tiring (eye strain) of the eyes. This may be worse in dim light. Other common symptoms are delays in focusing at near or distance, ocular discomfort, headache, asthenopia, squinting, fatigue or drowsiness from near work, increased working distance, need for brighter light for reading, and diplopia. Age is the major risk factor for the development of presbyopia, although the condition may occur prematurely as the result of factors such as trauma, systemic disease, cardiovascular disease, or a drug side effect.

Presbyopia cannot be prevented. It is an inevitable part of aging. However, people who do a lot of close visual work, such as working with a computer or intensive reading, may develop presbyopia earlier than others.

Presbyopia Diagnosis

Presbyopia can be diagnosed by an optometrist, ophthalmologist, or physician, who takes a complete medical history to determine the extent of the vision problem. The doctor also tests the vision by having the patient read the text at a typically comfortable distance. If the diagnosis of presbyopia is confirmed, the doctor may perform a test to determine the extent of the focusing problem and the appropriate lens prescription. In this test, the doctor asks the patient to look through corrective lenses and continues to increase the magnification power until the words on the page are clear and comfortable enough to be read by the patient. A thorough assessment of the health of the eyes and associated structures is an integral component of the comprehensive adult eye and vision examination. This examination can lead to the diagnosis of systemic diseases and disorders that have ocular manifestations.

Presbyopia Treatment

The goal of treatment is to compensate for the inability of the eyes to focus on nearby objects. Treatment options include wearing corrective eyeglasses (spectacle lenses) or contact lenses, undergoing refractive surgery, or getting lens implants for presbyopia. Presbyopia can be treated with corrective lenses. Glasses are the simplest way to regain the ability to see close objects. Contact lenses also can be used to treat presbyopia, although many people find it difficult to adjust to them. Bifocal contact lenses can be made, or monovision lenses, in which one eye has a contact lens with a prescription for distance vision, and the other eye has a contact lens for up-close vision.

Several types of surgery are available and new techniques and technologies are making them safer and more effective. Refractive surgical procedures include Conductive Keratoplasty, LASIK, LASEK, and Photorefractive Keratectomy. Current clinical management of presbyopia includes off-label treatment using nonsteroidal anti-inflammatory drugs (NSAIDs), parasympathetic agonists, miotic agents, or some other tempering agents. The most commonly used agents are Pilocarpine, Carbachol, Aceclidine, Brimonidine, Nepafenac, etc.

Presbyopia Epidemiology

The Presbyopia epidemiology division provides insights about historical and current Presbyopia 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 Presbyopia was 286,994,105 cases in the 7MM which are expected to grow during the forecast period, i.e., 2021–2030.

The disease epidemiology covered in the report provides historical as well as forecasted Presbyopia epidemiology [segmented as Total Prevalent Cases of Presbyopia, Total Diagnosed Cases of Presbyopia, Total Age-specific Cases of Presbyopia, Gender-specific Cases of Presbyopia, Severity-specific Cases of Presbyopia, and Total Treated cases of Presbyopia] 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- Presbyopia Epidemiology

Estimates show that the highest cases of Presbyopia in the 7MM were in the United States, followed by Germany, Japan, Italy, France, the United Kingdom, and Spain in 2020.

• In the United States, the total number of prevalent cases of Presbyopia was 117,369,699 cases in the year 2020 which are expected to grow during the forecast period, i.e., 2021–2030.
• In the year 2020, the total prevalent cases of Presbyopia were 134,726,460 cases in EU-5 which are expected to grow during the forecast period, i.e., 2021–2030.
• In Japan, the total number of prevalent cases of Presbyopia was 34,897,947 cases in the year 2020 which are expected to grow during the forecast period, i.e., 2021–2030.

Presbyopia Drug Chapters

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

Presbyopia Emerging Drugs

PresbiDrops/CSF-1 (Orasis Pharmaceuticals)

CSF-1, also known as PresbiDrops, is a corrective eye drop being developed by Orasis Pharmaceuticals to offer an alternative to reading glasses and intrusive surgical procedures to enhance the quality of life for people with presbyopia. CSF-1 is delivered directly to the eyes as a topical solution and provides a patented blend of current and well-studied ingredients with the potential for close vision restoration in people with presbyopia. It is 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. A Phase II clinical trial of CSF-1 showed very high success rates for two-line and three-line improvement, attesting that CSF-1 eliminates the need for reading glasses for many people. Also, CSF-1 had no negative impact on distance vision, night vision, and visual field.

MicroLine/Pilocarpine Ophthalmic (Eyenovia)

MicroLine is Eyenovia’s patented pilocarpine presbyopia formulation. 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. Pilocarpine works by creating a pinhole effect, which is done by constricting the pupil of the eye, similar to a pinhole camera, and bringing near and medium-distance objects into focus. The MicroLine of Eyenovia is a patented micro-dosed pilocarpine formulation distributed through the Optejet dispenser. Currently, the company has initiated a Phase III clinical trial wherein volunteer participants will be evaluated for eligibility during a screening visit. The US FDA has also accepted Eyenovia’s IND application for MicroLine in December 2020 for the improvement in near vision in patients with presbyopia.

UNR844/Lipoic acid choline ester (Novartis)

UNR844, formerly known as EV06, is being developed by Novartis as a new topical agent to boost the accommodative spectrum for presbyopia. UNR844 contains lipoic acid choline ester, a decreasing agent intended to decrease the disulfide bonds that form between proteins of the lens, thereby raising the crystalline lens deformability and increasing the accommodative amplitude. Novartis gained possession of this drug in December 2016 with the acquisition of Encore Vision. Currently, UNR844 has completed the Phase II of the clinical developmental stage.

AGN-190584 (AbbVie)

AbbVie’s Allergan is developing AGN-190584, an investigational optimized formulation of pilocarpine. It is a cholinergic muscarinic receptor agonist being investigated for treating symptoms associated with presbyopia as a topical, once-daily drop delivered by a proprietary vehicle. 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. AGN-190584 for the treatment of symptoms associated with presbyopia met their primary efficacy endpoint in Phase III GEMINI 1 and 2 clinical trials.

AGN-241622 (AbbVie)

AGN-241622 is a second investigational drug from AbbVie’s Allergan. It is an Alpha 2 agonist being investigated for the treatment of presbyopia; the drug is a small molecule that targets the Alpha 2 Adrenergic Receptor. AGN-241622 is currently being investigated in Phase I/II of clinical studies, and the study is estimated to be completed in August 2022.

Nyxol (Occuphire Pharma)

Nyxol is a preservative-free ophthalmic solution containing 0.75% phentolamine (or 1% phentolamine mesylate), a nonselective alpha-adrenergic antagonist that inhibits the contraction of the smooth muscle of the iris. Nyxol’s potential to improve near vision is based on its mechanism of reducing pupil diameter, which results in an increased depth of focus. It alone has been shown to reduce pupil diameter by approximately 20% and has significantly improved near visual acuity by one eye-chart line for over 24 h after an evening eye drop. It is being developed under the 505(b)(2) pathway.

VTI-001/Brimochol (Visus Therapeutics)

VTI-001, also known as Brimochol, combines two active ingredients: carbachol and brimonidine tartrate. It is the lead investigational medicine candidate being developed by Visus Therapeutics for adults who suffer from presbyopia. The company is investigating the drug as a prescription eye drop designed to correct the loss of near vision associated with presbyopia.

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

Presbyopia Market Outlook

Presbyopia is the gradual reduction in flexibility of the lens of the eye with age. A normal part of aging, presbyopia usually becomes noticeable between the ages of 40 and 50 as an inability to focus on near objects. Patients may experience a noteworthy visual disability if a correction is not made and may also develop problems maintaining the usual levels of activity and productivity at work and everyday activities. The goal of treatment is to compensate for the inability of the eyes to focus on nearby objects. Presbyopia cannot be cured, but properly prescribed glasses or contact lenses can make seeing up close much more comfortable.

The pharmacological control of presbyopia is a desirable option for those affected by presbyopia and with an increasing near vision spectacle dependence. 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.

At present, some companies have initiated clinical trials that investigate new treatment options. Key players such as Orasis Pharmaceuticals (PresbiDrops), Novartis (UNR844), Eyenovia (MicroLine), Allergan (acquired by AbbVie) (AGN-190584 and AGN-241622), Ocuphire Pharma (Nyxol), Visus therapeutics (VTI-001/Brimochol), and several others are investigating their candidates for the management of presbyopia in the 7MM.

Key Findings

The Presbyopia market size in the 7MM is expected to change during the study period 2018–2030. The therapeutic market of Presbyopia in the seven major markets is expected to increase during the study period (2018–2030) with a CAGR of 4%. According to the estimates, the highest market size of Presbyopia is found in the United States followed by Germany.

The United States Market Outlook

The total market size of Presbyopia therapies in the United States is expected to increase with a CAGR of 5.6% in the study period (2018–2030).

EU-5 Countries: Market Outlook

The total market size of Presbyopia therapies in EU-5 countries is expected to increase with a CAGR of 2.3% in the study period (2018–2030).

Japan Market Outlook

The total market size of Presbyopia therapies in Japan is expected to increase with a CAGR of 2.2% in the study period (2018–2030).

Presbyopia Pipeline Development Activities

The drugs which are in pipeline include:

• PresbiDrops/CSF-1 (Orasis Pharmaceuticals)
• MicroLine/Pilocarpine Ophthalmic (Eyenovia)
• UNR844/Lipoic acid choline ester (Novartis)
• AGN-190584 (AbbVie)
• AGN-241622 (AbbVie)
• Nyxol (Occuphire Pharma)
• VTI-001/Brimochol (Visus Therapeutics)

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

Analyst Commentary

• A majority (~3/4th cases) of the presbyopia patients are using the eyeglasses for correction of close-up vision problems. In terms of revenue as well, eyeglasses are contributing around 50% of the US market in 2018.
• Three companies are currently evaluating the role of their products in the late stage (i.e. phase III) of development for the treatment of presbyopia. Allergan (acquired by AbbVie) with AGN-190584, Orasis Pharmaceuticals with PresbiDrops (CSF-1), and Eyenovia with MicroLine (Pilocarpine). Novartis is also in the race with UNR844 (Lipoic acid choline ester, EV06) which is currently in phase II.
• AGN-190584 (pilocarpine 1.25%) is expected to capture the maximum patient share among the emerging therapies owing to early mover advantage, dosing advantage (i.e. once daily), and visibility around the phase III results. The company has recently announced that Phase III GEMINI 1 and 2 studies met the primary endpoint, reaching statistical significance in improvement in near vision, and has recently submitted a New Drug Application (NDA) to the US FDA.
• Eyenovia which is also trying to enter into the market with MicroLine (Pilocarpine) expected to face tough competition from AGN-190584 since both are based on the Pilocarpine. However, this will also provide a roadway for the approval of MicroLine as well if AGN-190584 successfully makes a way into the market.

Access and Reimbursement Scenario in Presbyopia Therapies

In 2005, the Centers for Medi­care & Medicaid Services (CMS) published a ruling that reversed decades of policy. Previously, services were either covered or not, with no middle ground. Under the 2005 decision, Medicare would reimburse what it will cost to restore usable vision—in other words the charge for replacing the cataract lens with a traditional IOL, which was around USD 105—if a Medicare recipient needs a presbyopia-correcting intraocular lens (IOL), and the doctors will bill the patient for extra costs associated with the new lenses. Before the new ruling, the CMS said in a statement, Medicare rules “prevented beneficiaries from accessing these lenses.” The CMS statement noted that Medicare is now protected by payment for traditional monofocal IOLs in an outpatient setting. Providers have typically not equipped Medicare beneficiaries with presbyopia-correcting IOLs “because the costs for this advanced technology significantly exceed Medicare’s payment.”

Apart from this, in January 2007, CMS issued a similar ruling for toric astigmatism-correcting IOLs. If the patient chooses a presbyopia-correcting IOL, they likely will be required to pay the added costs associated with these advanced techniques and lenses from their pocket. The average cost of RLE with a presbyopia-correcting IOL ranged from USD 4,704 million to USD 6,898 million per eye.

When a Medicare beneficiary agrees to have presbyopia- or astigmatic-cor­recting IOL, rather than a conventional IOL, the patient needs to be careful with the billing. In simpler terms, Medicare or the insurance will pay only the cost of a basic intraocular lens and accompanying cataract surgery. Use of a more expensive, presbyopia-correcting lens is considered an elective refractive procedure, a type of luxury, just as LASIK and PRK are refractive procedures that are not covered by health insurance. Moreover, there is not much information regarding the access to healthcare and reimbursement process of presbyopia as the lack of effective therapies is a high unmet need. There are certain companies involved in providing PAP and RAR program options; however, there is a scarcity of reliable information in that particular domain as well.

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 Presbyopia 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 Presbyopia 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

We perform Competitive and Market Intelligence analysis of the Presbyopia Market by using various Competitive Intelligence tools that includes – 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 Presbyopia, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies.
• Comprehensive insight has been provided into the Presbyopia epidemiology and treatment in the 7MM.
• Additionally, an all-inclusive account of both the current and emerging therapies for Presbyopia is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Presbyopia 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 Presbyopia market.

Report Highlights

• In the coming years, the Presbyopia 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 Presbyopia 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 Presbyopia. The launch of emerging therapies will considerably impact the Presbyopia market.
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Presbyopia.
• Our 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.

Presbyopia Report Insights

• Patient Population
• Therapeutic Approaches
• Presbyopia Pipeline Analysis
• Presbyopia Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Presbyopia Report Key Strengths

• 10 Years Forecast
• 7MM Coverage
• Presbyopia Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Presbyopia Report Assessment

• SWOT Analysis
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Conjoint Analysis
• Market Attractiveness
• Market Drivers and Barriers

Key Questions

Market Insights:

• What was the Presbyopia Market share (%) distribution in 2018 and how it would look like in 2030?
• What would be the Presbyopia 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 Presbyopia market size during the study period (2018–2030)?
• At what CAGR, the Presbyopia market is expected to grow in the 7MM during the study period (2018–2030)?
• What would be the Presbyopia market outlook across the 7MM during the study period (2018–2030)?
• What would be the Presbyopia 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?
• Presbyopia 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 Presbyopia market?

Epidemiology Insights:

• What are the disease risks, burdens, and unmet needs of Presbyopia?
• What is the historical Presbyopia 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 Presbyopia 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 Presbyopia?
• Out of all the 7MM countries, which country would have the highest prevalent population of Presbyopia 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 Presbyopia?

Current Treatment Scenario and Emerging Therapies:

• What are the current options for the treatment of Presbyopia?
• What are the current treatment guidelines for the treatment of Presbyopia in the US, Europe, and Japan?
• How many companies are developing therapies for the treatment of Presbyopia?
• How many therapies are developed by each company for the treatment of Presbyopia?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Presbyopia?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Presbyopia 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 Presbyopia and its status?
• What are the key designations that have been granted for the emerging therapies for Presbyopia?
• What is the global historical and forecasted market of Presbyopia?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the Presbyopia market.
• To understand the future market competition in the Presbyopia market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Presbyopia 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 Presbyopia market.
• To understand the future market competition in the Presbyopia market.