Dry Age-related Macular Degeneration - Market Insight, Epidemiology And Market Forecast - 2034

Key Highlights:

• Dry AMD has the potential to progress to geographic atrophy, a stage characterized by irreversible vision loss caused by the depletion of crucial retinal components such as retinal pigment epithelium (RPE), photoreceptors, and choriocapillaris in the macula.
• Although this condition is not uncommon in clinical practice, it can go undetected until the atrophy involves the fovea and affects central vision. Patients do not consult an ophthalmologist until they notice visual impairment due to foveal involvement.
• Multimodal imaging is advised for evaluating geographic atrophy presence and progression. Optical coherence tomography (OCT) stands out among these modalities as it proves valuable in identifying progression biomarkers in patients with intermediate AMD and in assessing the macula while quantifying geographic atrophy lesions.
• The majority of pipeline candidates for dry AMD target geographic atrophy, an advanced stage, rather than focusing on the early and intermediate stages.
• Detecting early biomarkers signaling the risk of progression from intermediate AMD to vision-threatening late stages is crucial for personalized management and timely intervention.
• Current interventions for dry AMD, such as nutritional supplements (e.g., AREDS formulation) and lifestyle modifications, aim to slow disease progression and manage symptoms. However, their efficacy varies among individuals, and they do not address the underlying pathology comprehensively.
• Several therapeutic modalities are currently in clinical trials for treating dry AMD, including complement pathway inhibitors, visual cycle modulators, reducing toxic byproducts, antioxidative therapy, neuroprotective agents, laser therapy, surgery, gene therapy, stem cell therapy, and miscellaneous treatments.
• SYFOVRE (pegcetacoplan) by Apellis and IZERVAY (avacincaptad pegol) by Astellas both are approved to treat geographic atrophy, also known as late-stage dry AMD. They are administered through eye injection. Now, with these two medications being the only options for geographic atrophy, a rivalry has emerged between the two companies as they compete for dominance in treating this condition. Clinicians face a challenge in comparing the efficacy data of IZERVAY and SYFOVRE as the studies for these treatments have distinct designs, making direct head-to-head comparisons difficult. However, post-marketing safety concerns are a major threat to both SYFOVRE and IZERVAY.
• The potential therapies that can mark a significant change in the upcoming forecast period include AVD-104, Tinlarebant (LBS-008), Gildeuretinol (ALK-001), Elamipretide, ANX007, Danicopan (ALXN2040), IONIS-FB-LRx (RG6299), JNJ-1887, CPCB-RPE1, OpRegen, and others.
• AVD-104 is striving to be the third therapy approved by the FDA for treating geographic atrophy secondary to AMD.
• Elamipretide is a mitochondrial stabilizing agent, the only class to have demonstrated a potential to improve low luminance visual acuity (LLVA) in dry AMD.
• Data from both CPCB-RPE1 and OpRegen provides a very believable likelihood that RPE cells provide an effective means for treating dry AMD with geographic atrophy.
• In 2023, in the 7MM the total market size of dry AMD was ~ USD 1,300 million.

DelveInsight's " Dry AMD - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of dry AMD, historical and forecasted epidemiology as well as the dry AMD market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The dry AMD market report provides current treatment practices, emerging drugs, dry AMD market share of individual therapies, and current and forecasted dry AMD market size from 2020 to 2034, segmented by seven major markets. The report also covers current dry AMD treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Dry AMD Disease Understanding and Treatment Algorithm

Dry AMD Overview

By 1965, the terminology surrounding AMD had gained widespread acceptance, with the condition classified into three clinical stages: early, intermediate, and advanced AMD. The earliest clinical sign of early AMD is the presence of drusen (>63 and =125 ?m in diameter), which hampers the patient's ability to adapt to changes in illumination. However, the most substantial central visual loss occurs in the intermediate and advanced stages, with advanced AMD encompassing geographic atrophy and neovascular AMD. Geographic atrophy is characterized by a gradual deterioration of the macular RPE, photoreceptor layer, and choroidal capillaries, resulting in progressive vision loss over time. Diagnosis requires thorough eye examinations, and management strategies focus on slowing disease progression and optimizing remaining vision. Despite efforts, a cure for advanced dry AMD remains elusive, emphasizing the critical need for ongoing research to develop effective treatments for this debilitating condition.

Dry AMD Diagnosis

Diagnosing dry AMD typically involves a comprehensive eye examination, during which an ophthalmologist or optometrist evaluates the retina for characteristic signs of the condition. These signs may include the presence of drusen, small yellow deposits beneath the retina, and changes in pigmentation. Advanced imaging techniques such as optical coherence tomography (OCT) and fundus autofluorescence imaging may also be employed to assess the extent of retinal degeneration. Early detection is crucial in managing dry AMD, as it allows for timely intervention to slow disease progression and preserve vision.

Further details related to diagnosis will be provided in the report.

Dry AMD Treatment

People with dry AMD typically experience impaired central vision but often retain peripheral vision, allowing them to perform many daily activities. While there is no cure for AMD, treatment options aim to slow down the progression of the disease and preserve vision. Studies suggest that supplements containing vitamins C and E, lutein, zeaxanthin, zinc, and copper may help slow the progression of dry AMD. Ongoing clinical trials are exploring various therapeutic approaches, including complement pathway inhibitors, visual cycle modulators, antioxidative therapy, neuroprotective agents, and stem cell therapy, among others. Complement pathway inhibitors show promise in reducing geographic atrophy progression, while stem cell therapy aims to restore retinal function. These advancements offer hope for improved management and potential restoration of vision in individuals with dry AMD.

Until recently, there were no proven therapies for geographic atrophy. In 2023, the US FDA approved SYFOVRE (in February) and IZERVAY (in August) for slowing the progression of lesions of geographic atrophy. While IZERVAY or SYFOVRE injections can slow down disease progression, it is important to note that they cannot reverse the effects or restore lost vision.

Further details related to treatment will be provided in the report...

Dry AMD Epidemiology

The dry AMD epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total prevalent cases of AMD, stage-specific prevalent cases of AMD, total prevalent cases of geographic atrophy, total prevalent cases of dry AMD, total diagnosed prevalent cases of dry AMD, age-specific cases of early and intermediate AMD, age-specific cases of geographic atrophy, geographic atrophy cases by visual impairment in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• The total prevalent cases of AMD in the 7MM was nearly 68,347,900 in 2023.
• Among the 7MM, the US accounted for the highest prevalent cases of dry AMD in 2023, with around 20,970,000 cases; these cases are expected to increase during the forecast period.
• Several researchers reported a declining prevalence of late AMD in the United States when comparing data from the 2000s with data gathered in previous decades.
• In 2023, the geographical atrophy accounted for nearly 955,900 cases in EU4 and the UK.
• According to the estimates, in Japan, it is observed that age-specific cases of geographic atrophy were most prevalent in the 85+ years age group, accounting for over 40% of total cases in 2023.
• Although there are relatively equal numbers of neovascular AMD and geographic atrophy in White populations, late AMD is less common among Japanese people than among white subjects. In Asian countries, although the prevalence of geographic atrophy is low, the rapidly aging population means that geographic atrophy is becoming an increasingly urgent and unmet medical need. The difference in the prevalence of AMD among races is also partly owing to genetic background; for example, some single nucleotide polymorphisms (SNPs) in complement factors are associated with AMD in Caucasians.

Dry AMD Drug Chapters

The drug chapter segment of the dry AMD report encloses a detailed analysis of the late-stage (Phase III ) and mid-stage (Phase II/III and Phase II) pipeline drugs. The current key players include Belite Bio (Tinlarebant), Alkeus Pharmaceuticals (ALK-001), Stealth BioTherapeutics (Elamipretide), Annexon Biosciences (ANX007), AstraZeneca/Alexion Pharmaceuticals (Danicopan), Ionis Pharmaceuticals/Roche (IONIS-FB-LRx), Regenerative Patch Technologies (CPCB-RPE1), Lineage Cell Therapeutics/Roche (OpRegen), Johnson & Johnson Innovative Medicine (JNJ-1887), and others.

The drug chapter also helps understand the dry AMD clinical trial details, pharmacological action, agreements and collaborations, approval, and patent details, and the latest news and press releases.

Marketed Drugs

IZERVAY (avacincaptad pegol): Astellas Pharma/Iveric Bio

IZERVAY, also known as avacincaptad pegol is designed to target and inhibit complement factor C5. Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of dry AMD. IZERVAY binds to C5 and inhibits its cleavage into the terminal fragments C5a and C5b. By inhibiting the formation of complement system terminal fragments, IZERVAY may decrease the activation of inflammasomes and the formation of membrane attack complexes (MAC), which occur at the end of the complement cascade. In August 2023, the US FDA approved IZERVAY for the treatment of geographic atrophy secondary to AMD. Concurrently, Astellas Pharma announced that the European Medicines Agency (EMA) has accepted Iveric Bio's MAA for avacincaptad pegol for the treatment of geographic atrophy secondary to AMD.

SYFOVRE (pegcetacoplan): Apellis Pharmaceuticals

SYFOVRE is a targeted C3 inhibitor designed to regulate excessive complement activation, which can lead to the onset and progression of many serious diseases. Pegcetacoplan is a type of synthetic cyclic peptide conjugated to a polyethylene glycol polymer that binds specifically to C3 and C3b. The company is evaluating pegcetacoplan in several clinical studies, including paroxysmal nocturnal hemoglobinuria (PNH), geographic atrophy (GA), cold agglutinin disease (CAD), warm antibody autoimmune hemolytic anemia (wAIHA), complement-dependent nephropathies (CDN). SYFOVRE is the first and only approved therapy for geographic atrophy secondary to AMD. In January 2024, the CHMP of the EMA adopted a negative opinion on the MAA of intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to AMD.

Emerging Drugs

Iptacopan (LNP023): Novartis

Novartis Pharmaceuticals is developing Iptacopan, an oral small-molecule inhibitor of complement factor B (FB) with potential immunomodulatory activity. Upon administration, FB inhibitor LNP023 binds to FB and prevents the formation of the alternative pathway (AP) C3-convertase (C3bBb). This limits the cleavage of C3 to the active fragment C3b and may prevent C3b-mediated extravascular hemolysis in certain complement-driven disorders such as intermediate age-related macular degeneration (iAMD), C3 glomerulopathy (C3G), paroxysmal nocturnal hemoglobinuria (PNH), etc. Recently, in December 2023, the US FDA approved FABHALTA (ipatocan) as the first oral monotherapy for adults with paroxysmal nocturnal hemoglobinuria (PNH) (Novartis, 2023). Currently, the company is investigating iptacopan in the Phase II trial (NCT05230537) for the treatment of patients with early and intermediate age-related macular degeneration.

ALK-001: Alkeus Pharmaceuticals

Allegro Ophthalmics is developing risuteganib (also known as ALG-1001), a breakthrough integrin-regulating therapy for ocular health that reduces mitochondrial dysfunction involved in intermediate dry AMD. By targeting multiple pathways, risuteganib helps reduce the cellular burden of oxidative stress and restores retinal homeostasis. Research suggests that risuteganib interferes with integrin functions that have been implicated in retinal diseases, giving it the potential for a broad-spectrum effect on different pathways of oxidative stress. Currently, the company has received the US FDA agreement under Special Protocol Assessment (SPA) for Phase IIb/III clinical trial of risuteganib for the treatment of intermediate, non-exudative age-related macular degeneration (dry AMD). Moreover, the overall protocol design of Phase IIb/III dry AMD clinical trial was finalized by the US FDA.

Drug Class Insight

Integrin Inhibitor

Integrin inhibitor have been effective in several preclinical models, and promising results have been reported thus far from clinical trials. Indeed, most of the current avB3 clinical investigations centre on treating eye diseases (age-related macular degeneration (AMD) using topically dosed or intravitreally injected small molecules and peptides, although these molecules also inhibit other av integrins and/or a5B1 to varying degrees. The molecules that have progressed the furthest in the clinic are risuteganib (Luminate, Allegro Ophthalmics). It is a small peptide integrin regulator protecting cells of the human RPE against dysfunction related to oxidative stress. With age, decreased mitochondrial oxidative phosphorylation increases the generation of reactive oxygen species and decreased metabolic activity, thus negatively affecting cellular bioenergetics and mitochondrial functioning. It is also known that RPE mitochondrial dysfunction contributes to the oxidative stress causing AMD.

Complement C5 inhibitors

Complement C5 inhibitors target the complement cascade, a part of the immune system involved in inflammation and tissue damage. By inhibiting C5, these drugs help mitigate the inflammatory response and prevent further damage to retinal cells. Additionally, complement inhibition may also have a protective effect on neighboring healthy cells, preserving overall retinal function.

In the advanced stages of dry AMD, complement C5 inhibitors play a crucial role in addressing the underlying inflammatory processes that contribute to disease progression. Dry AMD, particularly in its advanced form known as geographic atrophy, is characterized by the gradual degeneration of retinal cells, leading to vision loss. Research indicates that complement dysregulation and chronic inflammation play significant roles in the pathogenesis of AMD.

Dry AMD Market Outlook

Geographic atrophy, the advanced stage of dry AMD, has emerged as a prominent focus of research. Current investigations predominantly center on therapies targeting complement inhibitors of C3 and C5, pivotal factors in triggering inflammation and subsequent cell death within the eye. Extensive studies led by the National Eye Institute and esteemed researchers globally have unveiled the likelihood of an overactive complement system as a central player in the genesis of dry AMD and its evolution toward GA.

Enhancing comprehension of the pathophysiology of geographic atrophy resulting from dry AMD can benefit patients, optometrists, and ophthalmologists alike. This improved understanding could lead to more accurate identification and diagnosis of patients, potentially lessening the burden of the disease and extending their visual function over time.

The landscape of research and development in intermediate AMD has shifted to dry AMD, exemplified by Stealth Biotherapeutics redirecting its focus toward dry AMD. As seen in Elamipretide, a mitochondria-targeting antioxidant, has progressed to Phase II trials for dry AMD following promising outcomes in Phase I trials for intermediate AMD.

Immune response-targeting agents have emerged as the most advanced area of clinical research for geographic atrophy, marking a significant milestone as the first and only drug class to enter the market to date. The FDA approvals of IZERVAY (avacincaptad pegol) and SYFOVRE (pegcetacoplan) represent groundbreaking developments. Both medications have demonstrated their ability to effectively slow down the progression of geographic atrophy, thereby mitigating vision loss. These approvals signal a transformative shift in clinical practice, research priorities, investment decisions, and healthcare planning. While these breakthrough medications provide hope for individuals with late-stage dry AMD, they signify just the initial steps in advancing treatment options for geographic atrophy.

Numerous therapies are currently undergoing investigation to slow the progression of geographic atrophy and maintain macular function in patients with dry AMD. These potential treatment options in clinical trials, with a focus on disease prevention and halting disease progression, include ALK-001, Elamipretide, Risuteganib, EG-301, ANX 007, IONIS-FB-LRx, NGM 621, JNJ-1887 (AAVCAGsCD59), among others

Detailed market assessment will be provided in the final report.

Key Findings

• The total market size in the US for dry AMD was estimated to be ~USD 800 million in 2023, which is expected to grow during the forecast period (2024-2034).
• The total market size in EU4 and the UK for dry AMD was estimated to be nearly USD 300 million in 2023, which is expected to grow during the forecast period.

Dry AMD Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024-2034. The landscape of dry AMD treatment has experienced a transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of retinal physicians, ophthalmologists, professionals, and the entire healthcare community in their tireless pursuit of advancing eye care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

Dry AMD Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III, Phase II/III,and Phase II. It also analyzes key players involved in developing targeted therapeutics. Companies like Belite Bio, Alkeus Pharmaceuticals, Novartis and Allegro Ophthalmics actively engage in late and mid stage research and development efforts for dry AMD. The pipeline of dry AMD possesses potential drugs. However, there is a positive outlook for the therapeutics market, with expectations of growth during the forecast period (2024-2034).

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for dry AMD emerging therapy.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the dry AMD evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Retinal Specialist, ophthalmologist, eye specialist, and others.

DelveInsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as the Institute for Saint John's Health Center in California, Byers Eye Institute, McPherson Eye Research Institute, Retina specialist at Providence Saint John's Health Center, Department of Ophthalmology, Ophthalmic Consultants etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or dry AMD market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Market Access and Reimbursement

Referring patients with wet AMD to a retina specialist is common practice, but for patients with intermediate AMD, optometrists may feel that their options are limited. These patients require frequent monitoring to watch for the development of wet AMD. The current standard of care used by some eye care practitioners includes sending patients home with an Amsler grid and instructing them to use the grid every day to monitor their vision and report back to them with any changes in their vision. Although many optometrists still rely on the Amsler grid, clinical experience and research have shown that these and other high-risk patients often fail to use the Amsler grid between office visits to catch the earliest signs of neovascularization.

IZERVAY Patient assistance program is designed to meet the unique needs of eligible patients. Whether patients have commercial insurance, insurance that does not cover IZERVAY, are uninsured, or have government-issued insurance (such as Medicare), help may be available.

IZERVAY VisionPoints is a free patient engagement and educational support program for people to learn about GA and treatment with IZERVAY. IZERVAY VisionPoints is available to residents of the United States and Puerto Rico only. Health information is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. A prescription for IZERVAY is not required to participate in the IZERVAY VisionPoints program. Gift cards are limited to no more than USD 15 each, with an annual maximum of USD 75 per year. Void where prohibited by law.

Detailed market access and reimbursement assessment will be provided in the final report.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of dry AMD, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the dry AMD market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive dry AMD.

Dry AMD Report Insights

• Patient Population
• Therapeutic Approaches
• Dry AMD Pipeline Analysis
• Dry AMD Market Size and Trends
• Existing and Future Market Opportunity

Dry AMD Report Key Strengths

• Eleven Years Forecast
• The 7MM Coverage
• Dry AMD Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Dry AMD Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Analyst Views)

FAQs

• What was the dry AMD market size, the market size by therapies, market share (%) distribution in 2023, and what would it look like by 2034? What are the contributing factors for this growth?
• What can be the future treatment paradigm for dry AMD?
• What are the disease risks, burdens, and unmet needs of dry AMD? What will be the growth opportunities across the 7MM concerning the patient population with dry AMD?
• What are the current options for the treatment of dry AMD? What are the current guidelines for treating dry AMD in the 7MM?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?
• What is the patient share in Dry AMD?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving dry AMD.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis ranking of class-wise potential current and emerging therapies under the analyst view section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.