Disease Analysis: Wet Age-Related Macular Degeneration

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Report
69 Pages
May 2021
Region: Global
Citeline
ID: 5141807

Disease Overview

Age-related macular degeneration (AMD) is the progressive degradation of the part of the eye responsible for visual acuity, causing a loss of central vision. AMD is the leading cause of blindness in individuals who are over 65 years old. As the chances of experiencing any form of AMD increase with age, treatment of this disease is becoming even more important as life expectancies continue to rise in most regions

Latest Key Takeaways

Due to their ability to improve clinical outcomes and treat a more comprehensive patient population, vascular endothelial growth factor (VEGF) inhibitors have become the standard treatment used in wet age-related macular degeneration (wet AMD).
Currently, the use of photodynamic therapy with Visudyne, both alone and in combination with other treatments, is principally restricted to the second line of therapy and/or patients with the retinal angiomatous proliferation (RAP) or polypoidal choroidal vasculopathy (PCV) subtypes of AMD.
Even with Roche’s efforts to position Lucentis ahead of Avastin, and the introduction of Eylea into the market, bevacizumab’s low price continues to merit its off-label use in wet AMD. Although the treatment of cancer with bevacizumab can be costly, a much smaller dose of 1.25mg is used in wet AMD, dropping the cost of the drug to approximately $50 per dose. By comparison, a single dose of Lucentis costs approximately $1,950.
Despite the availability of cheap off-label bevacizumab and payer pressure to utilize bevacizumab prior to branded drugs, biologic therapies Eylea and Lucentis produce substantial revenues year-on-year due to their high prices and given the chronic nature of the disease and recurring treatment schedules. In 2019, Regeneron made $7.5bn in sales from Eylea, making it the seventh highest earning drug of the year overall.
Eylea and Lucentis will face biosimilar competition within the next few years given that the US Lucentis patent expired in June 2020. Although Eylea’s US patent is not set to expire until 2023, the drug will likely face indirect competition prior to this date from ranibizumab biosimilars, which are expected to enter the market as early as 2021.
Beovu is the newest entrant to the wet AMD market, and was approved by the FDA in October 2019 based on two Phase III trials (HAWK and HARRIER) demonstrating non-inferiority to Eylea. However, post-marketing safety issues have marred the uptake of this drug and will thwart Novartis’s hopes of taking substantial market share from Eylea.
In an effort to curtail sales erosion from ranibizumab biosimilars, Roche has two promising pipeline candidates nearing regulatory filing. The potential approvals and subsequent uptake of these assets, faricimab and ranibizumab Port Delivery System (PDS-1.0), which feature long periods of time between recurring treatments, will contribute directly to the forecasted growth of the wet AMD market.
An increase in disease prevalence will also contribute to market growth. The publisher estimates that in 2018, there were approximately 14.5 million prevalent cases of wet AMD in adults aged 50 years and over worldwide, and forecasts that number to increase to 17.6 million prevalent cases by 2027.
Numerous high-impact upcoming events for drugs in the wet AMD space are expected in 2021, including top-line results for Lytenava and AR-13503.
Despite the availability of anti-VEGF medicines that have revolutionized the treatment of wet AMD, pressing unmet needs remain. The challenge of recurring monthly or two-monthly injections over the span of years is difficult for patients, and studies analyzing real-world claims data indicate adherence to treatment is low and patients are generally undertreated, receiving fewer injections and less monitoring than in clinical trials. There is therefore a great need for better treatments that improve visual acuity, allow sustained delivery, are long-acting, and lower patient treatment burdens.

OVERVIEW

DISEASE BACKGROUND

Definition
Patient subtypes
Subtypes
Symptoms
Risk factors
Diagnosis

TREATMENT

VEGF inhibitors form the current standard treatment
Photodynamic therapy is typically reserved for specific subpopulations
Laterality

EPIDEMIOLOGY

Prevalence methodology

MARKETED DRUGSPIPELINE DRUGS

KEY REGULATORY EVENTS

First Biosimilar Version Of Lucentis
Allergan Pulls EU Filing For Abicipar Pegol
AbbVie Expected To Ditch Abicipar After US FDA Setback
First Ophthalmic Formulation Of Bevacizumab Among New Filings At EMA

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

Formycon Partners With Leukocare For Stable Biosimilar Formulations
Janssen Licenses Gene Therapy For AMD From Hemera
AbCellera Teams With Kodiak To Discover Ophthalmology Antibody Candidates
Henlius Finds Global Partner For Ophthalmic Bevacizumab
AffaMed Merges With EverInsight, Marrying CBC-Launched Firms
OliX, Thea Expand Collaboration For Ophthalmic Diseases

CLINICAL TRIAL LANDSCAPE

Sponsors by status
Sponsors by phase
Recent events

DRUG ASSESSMENT MODELMARKET DYNAMICS

FUTURE TRENDS

The overall market will expand with the approvals of novel pipeline assets
High biologic prices will translate to high revenues, despite restricted prescribing
Biosimilar competition will threaten current market leaders
Bevacizumab’s price allows it to remain a primary option for wet AMD

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

GB-102 for Wet AMD (March 9, 2021)
Faricimab for Wet AMD (February 12, 2021)
Faricimab for Wet AMD (January 24, 2021)
GB-102 for Wet AMD (September 4, 2020)
Lytenava for Wet AMD (August 26, 2020)
Multiple Drugs for Wet AMD (July 27, 2020)
Multiple Drugs for Wet AMD (July 22, 2020)
Darpin for Wet AMD (June 26, 2020)
Biosimilar Ranibizumab (Samsung Bioepis) for Wet AMD (May 18, 2020)
TRC105 for Wet AMD (March 9, 2020)
ADVM-022 for Wet AMD (February 8, 2020)

KEY UPCOMING EVENTS

UNMET NEEDS

Better delivery systems that allow sustained drug delivery
New therapies to improve long-term visual acuity

BIBLIOGRAPHYAPPENDIX

LIST OF FIGURES

Figure 1: Trends in prevalent cases of wet AMD, 2018–27
Figure 2: Overview of pipeline drugs for wet AMD in the US
Figure 3: Pipeline drugs for wet AMD, by company
Figure 4: Pipeline drugs for wet AMD, by drug type
Figure 5: Pipeline drugs for wet AMD, by classification
Figure 6: Probability of success in the wet AMD pipeline
Figure 7: Clinical trials in wet AMD
Figure 8: Top 10 drugs for clinical trials in wet AMD
Figure 9: Top 10 companies for clinical trials in wet AMD
Figure 10: Trial locations in wet AMD
Figure 11: Wet AMD trials status
Figure 12: Wet AMD trials sponsors, by phase
Figure 13: The publisher’s drug assessment summary for wet AMD
Figure 14: Market dynamics in wet AMD
Figure 15: Future trends in wet AMD
Figure 16: GB-102 for Wet AMD (March 9, 2021): Phase IIb - ALTISSIMO
Figure 17: Faricimab for Wet AMD (February 12, 2021): Phase III - LUCERNE, Phase III - TENAYA
Figure 18: Faricimab for Wet AMD (January 24, 2021): Phase III - LUCERNE, Phase III - TENAYA
Figure 19: GB-102 for Wet AMD (September 4, 2020): Phase I/IIa - ADAGIO
Figure 20: Lytenava for Wet AMD (August 26, 2020): Phase III - NORSE 1 (Australia)
Figure 21: Multiple Drugs for Wet AMD (July 22, 2020): Phase III - Archway
Figure 22: Biosimilar Ranibizumab (Samsung Bioepis) for Wet AMD (May 18, 2020): Phase III - vs. Lucentis
Figure 23: TRC105 for Wet AMD (March 9, 2020): Phase IIa - AVANTE (w/Lucentis)
Figure 24: ADVM-022 for Wet AMD (February 8, 2020): Phase I - OPTIC
Figure 25: Key upcoming events in wet AMD

LIST OF TABLES

Table 1: Segmentation of neovascular lesions, by angiographic presentation
Table 2: Treatment guidelines overview
Table 3: Prevalent cases of wet AMD, 2018–27
Table 4: Marketed drugs for wet AMD
Table 5: Pipeline drugs for wet AMD
Table 6: Historical global sales, by drug ($m), 2016–20
Table 7: Forecasted global sales, by drug ($m), 2021–25
Table 8: GB-102 for Wet AMD (March 9, 2021)
Table 9: Faricimab for Wet AMD (February 12, 2021)
Table 10: Faricimab for Wet AMD (January 24, 2021)
Table 11: GB-102 for Wet AMD (September 4, 2020)
Table 12: Lytenava for Wet AMD (August 26, 2020)
Table 13: Multiple Drugs for Wet AMD (July 27, 2020)
Table 14: Multiple Drugs for Wet AMD (July 22, 2020)
Table 15: Darpin for Wet AMD (June 26, 2020)
Table 16: Biosimilar Ranibizumab (Samsung Bioepis) for Wet AMD (May 18, 2020)
Table 17: TRC105 for Wet AMD (March 9, 2020)
Table 18: ADVM-022 for Wet AMD (February 8, 2020)

Table of Contents

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