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, AR-13503, and RGX-314.
- 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
31 KEY REGULATORY EVENTS
31 Roche Seeks EU Marketing Approval For Novel Eye Disease Drug Faricimab
31 Ranibizumab Implant Filed
31 Samsung Bioepis Backed By EMA For First Lucentis Biosimilar
31 Ophthalmic Bevacizumab Reaches Critical Review Stage In EU
32 Roche’s Novel Ranibizumab Implant Among Myriad New Filings In EU
32 Lupin Pursues India Approval For Lucentis Biosimilar
32 First Biosimilar Version Of Lucentis
32 Allergan Pulls EU Filing For Abicipar Pegol
34 PROBABILITY OF SUCCESS
35 LICENSING AND ASSET ACQUISITION DEALS
35 PanOptica Confirms Deal With Zhaoke For Eye Drop Rights In Asia
35 Formycon Partners With Leukocare For Stable Biosimilar Formulations
35 Janssen Licenses Gene Therapy For AMD From Hemera
35 AbCellera Teams With Kodiak To Discover Ophthalmology Antibody Candidates
36 Henlius Finds Global Partner For Ophthalmic Bevacizumab
36 AffaMed Merges With EverInsight, Marrying CBC-Launched Firms
36 OliX, Thea Expand Collaboration For Ophthalmic Diseases
38 CLINICAL TRIAL LANDSCAPE
39 Sponsors by status
40 Sponsors by phase
41 Recent events
45 DRUG ASSESSMENT MODEL
48 MARKET DYNAMICS
49 FUTURE TRENDS
49 The overall market will expand with the approvals of novel pipeline assets
49 High biologic prices will translate to high revenues, despite restricted prescribing
49 Biosimilar competition will threaten current market leaders
50 Bevacizumab’s price allows it to remain a primary option for wet AMD
51 CONSENSUS FORECASTS
53 RECENT EVENTS AND ANALYST OPINION
53 Biosimilar Ranibizumab (Stada/Xbrane) for Wet AMD (June 29, 2021)
54 Beovu for Wet AMD (May 28, 2021)
55 GB-102 for Wet AMD (March 9, 2021)
56 Faricimab for Wet AMD (February 12, 2021)
58 Faricimab for Wet AMD (January 24, 2021)
59 GB-102 for Wet AMD (September 4, 2020)
61 Lytenava for Wet AMD (August 26, 2020)
63 Multiple Drugs for Wet AMD (July 27, 2020)
64 Multiple Drugs for Wet AMD (July 22, 2020)
65 Darpin for Wet AMD (June 26, 2020)
66 Biosimilar Ranibizumab (Samsung Bioepis) for Wet AMD (May 18, 2020)
67 TRC105 for Wet AMD (March 9, 2020)
68 ADVM-022 for Wet AMD (February 8, 2020)
71 KEY UPCOMING EVENTS
72 UNMET NEEDS
72 Better delivery systems that allow sustained drug delivery
72 New therapies to improve long-term visual acuity
73 BIBLIOGRAPHY
75 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
34 Figure 6: Probability of success in the wet AMD pipeline
38 Figure 7: Clinical trials in wet AMD
38 Figure 8: Top 10 drugs for clinical trials in wet AMD
39 Figure 9: Top 10 companies for clinical trials in wet AMD
39 Figure 10: Trial locations in wet AMD
40 Figure 11: Wet AMD trials status
41 Figure 12: Wet AMD trials sponsors, by phase
45 Figure 13: Datamonitor Healthcare’s drug assessment summary for wet AMD
48 Figure 14: Market dynamics in wet AMD
49 Figure 15: Future trends in wet AMD
54 Figure 16: Biosimilar Ranibizumab (Stada/Xbrane) for Wet AMD (June 29, 2021): Phase III – XPLORE
56 Figure 17: GB-102 for Wet AMD (March 9, 2021): Phase IIb – ALTISSIMO
58 Figure 18: Faricimab for Wet AMD (February 12, 2021): Phase III – LUCERNE, Phase III – TENAYA
59 Figure 19: Faricimab for Wet AMD (January 24, 2021): Phase III – LUCERNE, Phase III – TENAYA
61 Figure 20: GB-102 for Wet AMD (September 4, 2020): Phase I/IIa – ADAGIO
63 Figure 21: Lytenava for Wet AMD (August 26, 2020): Phase III – NORSE 1 (Australia)
65 Figure 22: Multiple Drugs for Wet AMD (July 22, 2020): Phase III – Archway
67 Figure 23: Biosimilar Ranibizumab (Samsung Bioepis) for Wet AMD (May 18, 2020): Phase III – vs. Lucentis
68 Figure 24: TRC105 for Wet AMD (March 9, 2020): Phase IIa – AVANTE (w/Lucentis)
70 Figure 25: ADVM-022 for Wet AMD (February 8, 2020): Phase I – OPTIC
71 Figure 26: 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
51 Table 6: Historical global sales, by drug ($m), 2016–20
52 Table 7: Forecasted global sales, by drug ($m), 2021–25
53 Table 8: Biosimilar Ranibizumab (Stada/Xbrane) for Wet AMD (June 29, 2021)
54 Table 9: Beovu for Wet AMD (May 28, 2021)
55 Table 10: GB-102 for Wet AMD (March 9, 2021)
57 Table 11: Faricimab for Wet AMD (February 12, 2021)
58 Table 12: Faricimab for Wet AMD (January 24, 2021)
60 Table 13: GB-102 for Wet AMD (September 4, 2020)
61 Table 14: Lytenava for Wet AMD (August 26, 2020)
63 Table 15: Multiple Drugs for Wet AMD (July 27, 2020)
64 Table 16: Multiple Drugs for Wet AMD (July 22, 2020)
65 Table 17: Darpin for Wet AMD (June 26, 2020)
66 Table 18: Biosimilar Ranibizumab (Samsung Bioepis) for Wet AMD (May 18, 2020)
68 Table 19: TRC105 for Wet AMD (March 9, 2020)
69 Table 20: ADVM-022 for Wet AMD (February 8, 2020)
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