Summary

KEY INSIGHTS
Age-related macular degeneration (AMD) is a progressive eye disease primarily affecting individuals over the age of 50, particularly within the highly geriatric population, leading to the deterioration of the macula, the central region of the retina. This condition results in a gradual loss of central vision, making daily activities such as reading and driving increasingly challenging. AMD is a major cause of irreversible blindness, especially in developed countries, and significantly impacts the quality of life for those affected.
AMD presents in two main forms: dry age-related macular degeneration (nonexudative or atrophic), which is characterized by thinning and atrophy of the macula and is most common in the early-stage AMD, and wet AMD (exudative or neovascular), which involves abnormal blood vessel growth that leaks fluid or blood into the macula, leading to rapid vision loss. The wet macular degeneration is primarily managed with ophthalmic pharmaceuticals, such as anti-VEGF drugs, which target the abnormal blood vessel growth associated with this severe condition.
MARKET INSIGHTS
Key growth enablers of the dry age macular degeneration (dry AMD) market:
• Strong development pipeline for dry AMD treatments
• Increasing geriatric population and rising prevalence of age-related macular degeneration (AMD)
o Age-related macular degeneration (AMD) is a leading cause of vision loss among individuals with eye disorders, with its risk escalating as people age. In the United States, AMD is a major contributor to vision impairment, especially among older adults. The National Eye Institute reports that over 14% of white Americans aged 80 and older are affected by this condition.
o The prevalence of age-related macular degeneration is further expected to double over the next 20 years due to the increasing geriatric populations, highlighting the urgent need for effective dry age-related macular degeneration diagnosis and treatment strategies. As the number of elderly individuals increases, so does the incidence of AMD, which is poised to become an even more pressing public health concern.
o Currently, there are no effective or approved treatments for dry age-related macular degeneration, nor is there a method to prevent its progression to the more severe wet AMD. Consequently, the development of new therapeutic agents and strategies is essential for managing and preventing this vision-threatening condition. This need for innovation is expected to drive growth in the AMD treatment market during the forecast period.
• Supportive medicare policies for AMD management
Key growth restraining factors of the dry age macular degeneration (dry AMD) market:
• Challenges in early detection
o It is estimated that 8% of the global population has early-stage age-related macular degeneration (AMD), with 15% of these individuals likely to advance to late-stage disease within 15 years of diagnosis. As the global population ages, there is a growing need for earlier diagnosis and intervention to effectively manage this condition.
o Age-related macular degeneration imposes a substantial burden on both individuals and healthcare systems. In the United States, annual direct costs related to AMD medical claims are estimated to range between 575 and 733 million USD. Those with late-stage AMD frequently experience severe loss of independence, elevated rates of depression, and a higher risk of falls.
o The dry form of AMD may manifest as drusen in the macula or atrophy of the retinal pigment epithelium or choriocapillaris. Since patients with dry AMD can often preserve good vision for many years, early detection is frequently overlooked. This delay in diagnosis can hinder the growth of the AMD treatment and intervention market.
• Unsuccessful clinical trial results
• Shortage of approved treatments
We are equipped to provide comprehensive data across all stages of development, including Pre-Clinical, Mid-Stage, Late-Stage, and IND (Investigational New Drug) phases.
Dry Age Macular Degeneration (Dry AMD) | Disease Overview
• Introduction
• Symptoms
o In the early stages of age-related macular degeneration (AMD), symptoms are typically absent, but an ophthalmologist can identify drusen deposits before any visual changes become evident. In the intermediate stage, some individuals may notice minor vision changes, such as slight blurriness or difficulty adjusting from bright to dim lighting. However, many people remain asymptomatic at this stage.
o As AMD advances to the later stage, symptoms become more pronounced. Individuals may observe dark or gray spots in the center of their visual field, and objects in their central vision might appear distorted or blurred. Eventually, central vision may be entirely obscured, although peripheral vision usually remains unaffected.
o In the late stages of AMD, individuals may experience significant visual impairment, making it challenging to recognize faces or read. While peripheral vision is generally preserved, interpreting details in the peripheral field can be difficult. A small percentage of dry AMD cases may advance to wet AMD, leading to rapid and severe vision loss. The type of AMD and individual health conditions can influence the progression rate to late-stage vision loss.
• Risk Factors
• Pathogenesis
o Age-related macular degeneration (AMD) is a complex, multifactorial disease with a pathogenesis that is not fully understood. Several factors, including genetic predisposition, oxidative stress, environmental influences, inflammation, and ischemia, contribute to its development.
o The early stages of AMD are characterized by the presence of drusen, which are deposits that develop beneath the retina. These deposits interfere with the function of the retinal pigment epithelium (RPE) and Bruch's membrane, causing the buildup of harmful substances.
• Etiology
• Diagnosis
• Treatment
COMPETITIVE INSIGHTS
Major players in the dry age macular degeneration (dry AMD) market:
• Alkeus Pharmaceuticals Inc
• Belite Bio
• Allergo Ophthalmics LLC
• Ionis Pharmaceuticals
• NGM Biopharmaceuticals Inc
• Dobecure SL
• Annexon Biosciences
• Evergreen Therapeutics Inc
F Hoffmann-La Roche Ltd is a biotechnology company that provides innovative solutions for major disease areas. Founded in 1896 and headquartered in Basel, Switzerland, the company offers treatments for cancer, infectious diseases, autoimmune disorders, and ophthalmological conditions. Roche's offerings include tissue-based cancer diagnostics, in vitro solutions, and diabetes management products. The company is dedicated to researching and developing new methods for disease prevention, diagnosis, and treatment.
In December 2020, Roche launched a clinical trial (NCT04615325) to assess the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 in patients with geographic atrophy (GA) due to age-related macular degeneration (AMD). This study involves administering a single intravitreal injection of RO7303359, with participants receiving escalating doses to identify the maximum tolerated dose (MTD) or maximum tested dose (MTeD). The trial, which is currently active and includes 63 participants, is anticipated to be completed by February 2023.
Frequently Asked Questions (FAQs):
1.) How is dry AMD diagnosed?
A: Dry AMD is diagnosed through a comprehensive eye examination, which may include a visual acuity test, dilated eye exam, and imaging tests such as optical coherence tomography (OCT) or fluorescein angiography. An ophthalmologist can detect drusen, the yellow deposits under the retina, which are a hallmark of AMD.
2.) What causes dry AMD?
A: The precise cause of dry AMD is not known, but it is thought to arise from a combination of genetic and environmental factors. Risk factors include aging, a family history of AMD, smoking, high blood pressure, high cholesterol, obesity, and prolonged exposure to sunlight.

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Table of Contents

TABLE OF CONTENTS
1. INTRODUCTION TO THE REPORT
2. DRY AGE-RELATED MACULAR DEGENERATION: SUMMARY
3. OVERVIEW
3.1. INTRODUCTION
3.2. SYMPTOMS
3.3. RISK FACTORS
3.4. PATHOGENESIS
3.5. ETIOLOGY
3.6. DIAGNOSIS
3.7. TREATMENT
4. MARKET DYNAMICS
4.1. KEY DRIVERS
4.1.1. STRONG DEVELOPMENT PIPELINE FOR DRY AMD TREATMENTS
4.1.2. INCREASING GERIATRIC POPULATION AND RISING PREVALENCE OF AGE-RELATED MACULAR DEGENERATION (AMD)
4.1.3. SUPPORTIVE MEDICARE POLICIES FOR AMD MANAGEMENT
4.2. KEY RESTRAINTS
4.2.1. CHALLENGES IN EARLY DETECTION
4.2.2. UNSUCCESSFUL CLINICAL TRIAL RESULTS
4.2.3. SHORTAGE OF APPROVED TREATMENTS
5. PIPELINE THERAPEUTICS
5.1. PIPELINE SCENARIO
5.2. COMPARATIVE ANALYSIS: PRODUCTS IN VARIOUS PHASES
6. THERAPEUTIC ASSESSMENT: ACTIVE PRODUCTS
6.1. EVALUATION BY ROUTE OF ADMINISTRATION
6.2. EVALUATION BY STAGE AND ROUTE OF ADMINISTRATION
6.3. EVALUATION BY MOLECULE TYPE
6.4. EVALUATION BY STAGE AND MOLECULE TYPE
6.5. EVALUATION BY PRODUCT TYPE
6.6. EVALUATION BY STAGE AND PRODUCT TYPE
7. EARLY-STAGE PRODUCTS (PHASE I/II)
7.1. COMPARATIVE ANALYSIS
7.2. VOY-101: PERCEIVE BIOTHERAPEUTICS INC
7.2.1. PRODUCT DESCRIPTION
7.2.2. RESEARCH AND DEVELOPMENT
7.2.3. PRODUCT DEVELOPMENTAL ACTIVITIES
7.3. OCU410: OCUGEN
7.3.1. PRODUCT DESCRIPTION
7.3.2. RESEARCH AND DEVELOPMENT
7.3.3. PRODUCT DEVELOPMENTAL ACTIVITIES
7.4. RPESC-RPE-4W: LUXA BIOTECHNOLOGY
7.4.1. PRODUCT DESCRIPTION
7.4.2. RESEARCH AND DEVELOPMENT
7.4.3. PRODUCT DEVELOPMENTAL ACTIVITIES
7.5. MA09-HRPE (ASP7317): ASTELLAS PHARMA
7.5.1. PRODUCT DESCRIPTION
7.5.2. RESEARCH AND DEVELOPMENT
7.6. CPCB-RPE1: REGENERATIVE PATCH TECHNOLOGIES
7.6.1. PRODUCT DESCRIPTION
7.6.2. RESEARCH AND DEVELOPMENT
7.6.3. SAFETY AND EFFICACY
8. EARLY-STAGE PRODUCTS (PHASE I)
8.1. COMPARATIVE ANALYSIS
8.2. RO7303359: HOFFMANN-LA ROCHE
8.2.1. PRODUCT DESCRIPTION
8.2.2. RESEARCH AND DEVELOPMENT
8.3. OLX301A: OLIX PHARMACEUTICALS
8.3.1. PRODUCT DESCRIPTION
8.3.2. RESEARCH AND DEVELOPMENT
8.3.3. PRODUCT DEVELOPMENTAL ACTIVITIES
8.4. BI 771716: BOEHRINGER INGELHEIM
8.4.1. PRODUCT DESCRIPTION
8.4.2. RESEARCH AND DEVELOPMENT
8.4.3. PRODUCT DEVELOPMENTAL ACTIVITIES
8.5. ONL 1204: ONL THERAPEUTICS
8.5.1. PRODUCT DESCRIPTION
8.5.2. RESEARCH AND DEVELOPMENT
8.5.3. PRODUCT DEVELOPMENTAL ACTIVITIES
8.6. REMOFUSCIN: KATAIRO
8.6.1. PRODUCT DESCRIPTION
9. STRATEGIC DEVELOPMENTS
9.1. PARTNERSHIPS & AGREEMENTS
10. UNMET NEEDS