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. Datamonitor Healthcare 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.
CONTENTS
7 OVERVIEW
8 DISEASE BACKGROUND
8 Definition
8 Patient subtypes
9 Subtypes
10 Symptoms
11 Risk factors
11 Diagnosis
12 TREATMENT
15 VEGF inhibitors form the current standard treatment
15 Photodynamic therapy is typically reserved for specific subpopulations
15 Laterality
16 EPIDEMIOLOGY
16 Prevalence methodology
19 MARKETED DRUGS
22 PIPELINE DRUGS
30 KEY REGULATORY EVENTS
30 First Biosimilar Version Of Lucentis
30 Allergan Pulls EU Filing For Abicipar Pegol
30 AbbVie Expected To Ditch Abicipar After US FDA Setback
30 First Ophthalmic Formulation Of Bevacizumab Among New Filings At EMA
32 PROBABILITY OF SUCCESS
33 LICENSING AND ASSET ACQUISITION DEALS
33 Formycon Partners With Leukocare For Stable Biosimilar Formulations
33 Janssen Licenses Gene Therapy For AMD From Hemera
33 AbCellera Teams With Kodiak To Discover Ophthalmology Antibody Candidates
33 Henlius Finds Global Partner For Ophthalmic Bevacizumab
34 AffaMed Merges With EverInsight, Marrying CBC-Launched Firms
34 OliX, Thea Expand Collaboration For Ophthalmic Diseases
35 CLINICAL TRIAL LANDSCAPE
36 Sponsors by status
37 Sponsors by phase
38 Recent events
41 DRUG ASSESSMENT MODEL
44 MARKET DYNAMICS
45 FUTURE TRENDS
45 The overall market will expand with the approvals of novel pipeline assets
45 High biologic prices will translate to high revenues, despite restricted prescribing
45 Biosimilar competition will threaten current market leaders
46 Bevacizumab’s price allows it to remain a primary option for wet AMD
47 CONSENSUS FORECASTS
49 RECENT EVENTS AND ANALYST OPINION
49 GB-102 for Wet AMD (March 9, 2021)
50 Faricimab for Wet AMD (February 12, 2021)
52 Faricimab for Wet AMD (January 24, 2021)
53 GB-102 for Wet AMD (September 4, 2020)
55 Lytenava for Wet AMD (August 26, 2020)
56 Multiple Drugs for Wet AMD (July 27, 2020)
57 Multiple Drugs for Wet AMD (July 22, 2020)
58 Darpin for Wet AMD (June 26, 2020)
59 Biosimilar Ranibizumab (Samsung Bioepis) for Wet AMD (May 18, 2020)
61 TRC105 for Wet AMD (March 9, 2020)
62 ADVM-022 for Wet AMD (February 8, 2020)
64 KEY UPCOMING EVENTS
65 UNMET NEEDS
65 Better delivery systems that allow sustained drug delivery
65 New therapies to improve long-term visual acuity
66 BIBLIOGRAPHY
68 APPENDIX
LIST OF FIGURES
18 Figure 1: Trends in prevalent cases of wet AMD, 2018–27
22 Figure 2: Overview of pipeline drugs for wet AMD in the US
22 Figure 3: Pipeline drugs for wet AMD, by company
23 Figure 4: Pipeline drugs for wet AMD, by drug type
23 Figure 5: Pipeline drugs for wet AMD, by classification
32 Figure 6: Probability of success in the wet AMD pipeline
35 Figure 7: Clinical trials in wet AMD
35 Figure 8: Top 10 drugs for clinical trials in wet AMD
36 Figure 9: Top 10 companies for clinical trials in wet AMD
36 Figure 10: Trial locations in wet AMD
37 Figure 11: Wet AMD trials status
38 Figure 12: Wet AMD trials sponsors, by phase
41 Figure 13: Datamonitor Healthcare’s drug assessment summary for wet AMD
44 Figure 14: Market dynamics in wet AMD
45 Figure 15: Future trends in wet AMD
50 Figure 16: GB-102 for Wet AMD (March 9, 2021): Phase IIb – ALTISSIMO
52 Figure 17: Faricimab for Wet AMD (February 12, 2021): Phase III – LUCERNE, Phase III – TENAYA
53 Figure 18: Faricimab for Wet AMD (January 24, 2021): Phase III – LUCERNE, Phase III – TENAYA
55 Figure 19: GB-102 for Wet AMD (September 4, 2020): Phase I/IIa – ADAGIO
56 Figure 20: Lytenava for Wet AMD (August 26, 2020): Phase III – NORSE 1 (Australia)
58 Figure 21: Multiple Drugs for Wet AMD (July 22, 2020): Phase III – Archway
61 Figure 22: Biosimilar Ranibizumab (Samsung Bioepis) for Wet AMD (May 18, 2020): Phase III – vs. Lucentis
62 Figure 23: TRC105 for Wet AMD (March 9, 2020): Phase IIa – AVANTE (w/Lucentis)
63 Figure 24: ADVM-022 for Wet AMD (February 8, 2020): Phase I – OPTIC
64 Figure 25: Key upcoming events in wet AMD
LIST OF TABLES
10 Table 1: Segmentation of neovascular lesions, by angiographic presentation
13 Table 2: Treatment guidelines overview
17 Table 3: Prevalent cases of wet AMD, 2018–27
20 Table 4: Marketed drugs for wet AMD
24 Table 5: Pipeline drugs for wet AMD
47 Table 6: Historical global sales, by drug ($m), 2016–20
48 Table 7: Forecasted global sales, by drug ($m), 2021–25
49 Table 8: GB-102 for Wet AMD (March 9, 2021)
51 Table 9: Faricimab for Wet AMD (February 12, 2021)
52 Table 10: Faricimab for Wet AMD (January 24, 2021)
54 Table 11: GB-102 for Wet AMD (September 4, 2020)
55 Table 12: Lytenava for Wet AMD (August 26, 2020)
57 Table 13: Multiple Drugs for Wet AMD (July 27, 2020)
58 Table 14: Multiple Drugs for Wet AMD (July 22, 2020)
59 Table 15: Darpin for Wet AMD (June 26, 2020)
60 Table 16: Biosimilar Ranibizumab (Samsung Bioepis) for Wet AMD (May 18, 2020)
61 Table 17: TRC105 for Wet AMD (March 9, 2020)
62 Table 18: ADVM-022 for Wet AMD (February 8, 2020)
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