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 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 2020 and 2021, including a European Committee for Medicinal Products for Human Use (CHMP) opinion for DARPin and Phase III topline trial results for Lytenava.
- 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 bi-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 First Biosimilar Version Of Lucentis
31 Allergan Pulls EU Filing For Abicipar Pegol
31 AbbVie Expected To Ditch Abicipar After US FDA Setback
31 First Ophthalmic Formulation Of Bevacizumab Among New Filings At EMA
32 Beovu & Recarbrio Among Five Drugs On Track For EU-Wide Approval
32 Keeping Track: Scenesse, Reyvow, and Beovu Make Trio Of Novel Approvals
33 PROBABILITY OF SUCCESS
34 LICENSING AND ASSET ACQUISITION DEALS
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
39 DRUG ASSESSMENT MODEL
42 MARKET DYNAMICS
43 FUTURE TRENDS
43 The overall market will expand with the approvals of novel pipeline assets
43 High biologic prices will translate to high revenues, despite restricted prescribing
43 Biosimilar competition will threaten current market leaders
44 Bevacizumab’s price allows it to remain a primary option for wet AMD
45 CONSENSUS FORECASTS
46 RECENT EVENTS AND ANALYST OPINION
46 GB-102 for Wet AMD (September 4, 2020)
47 Lytenava for Wet AMD (August 26, 2020)
49 Multiple Drugs for Wet AMD (July 27, 2020)
50 Multiple Drugs for Wet AMD (July 22, 2020)
51 Darpin for Wet AMD (June 26, 2020)
52 Biosimilar Ranibizumab (Samsung Bioepis) for Wet AMD (May 18, 2020)
53 TRC105 for Wet AMD (March 9, 2020)
54 ADVM-022 for Wet AMD (February 8, 2020)
56 RGX-314 for Wet AMD (September 4, 2019)
57 OPT-302 for Wet AMD (August 6, 2019)
59 AKST4290 for Wet AMD (July 27, 2019)
61 Multiple Drugs for Wet AMD (June 25, 2019)
62 Darpin for Wet AMD (April 2, 2019)
65 KEY UPCOMING EVENTS
66 UNMET NEEDS
66 Better delivery systems that allow sustained drug delivery
66 New therapies to improve long-term visual acuity
67 BIBLIOGRAPHY
68 Prescription information
69 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
23 Figure 3: Pipeline drugs for wet AMD, by company
23 Figure 4: Pipeline drugs for wet AMD, by drug type
24 Figure 5: Pipeline drugs for wet AMD, by classification
33 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
39 Figure 13: Datamonitor Healthcare’s drug assessment summary for wet AMD
42 Figure 14: Market dynamics in wet AMD
43 Figure 15: Future trends in wet AMD
47 Figure 16: GB-102 for Wet AMD (September 4, 2020): Phase I/IIa – ADAGIO
49 Figure 17: Lytenava for Wet AMD (August 26, 2020): Phase III – NORSE 1 (Australia)
51 Figure 18: Multiple Drugs for Wet AMD (July 22, 2020): Phase III – Archway
53 Figure 19: Biosimilar Ranibizumab (Samsung Bioepis) for Wet AMD (May 18, 2020): Phase III – vs. Lucentis
54 Figure 20: TRC105 for Wet AMD (March 9, 2020): Phase IIa – AVANTE (w/Lucentis)
56 Figure 21: ADVM-022 for Wet AMD (February 8, 2020): Phase I – OPTIC
59 Figure 22: OPT-302 for Wet AMD (August 6, 2019): Phase IIb – w/Ranibizumab
61 Figure 23: AKST4290 for Wet AMD (July 27, 2019): Phase IIa – ALK4290-202 (Hungary/Poland)
64 Figure 24: Darpin for Wet AMD (April 2, 2019): Phase II – MAPLE
65 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
25 Table 5: Pipeline drugs for wet AMD
45 Table 6: Historical global sales, by drug ($m), 2015–19
45 Table 7: Forecasted global sales, by drug ($m), 2020–24
46 Table 8: GB-102 for Wet AMD (September 4, 2020)
47 Table 9: Lytenava for Wet AMD (August 26, 2020)
49 Table 10: Multiple Drugs for Wet AMD (July 27, 2020)
50 Table 11: Multiple Drugs for Wet AMD (July 22, 2020)
51 Table 12: Darpin for Wet AMD (June 26, 2020)
52 Table 13: Biosimilar Ranibizumab (Samsung Bioepis) for Wet AMD (May 18, 2020)
54 Table 14: TRC105 for Wet AMD (March 9, 2020)
55 Table 15: ADVM-022 for Wet AMD (February 8, 2020)
57 Table 16: RGX-314 for Wet AMD (September 4, 2019)
58 Table 17: OPT-302 for Wet AMD (August 6, 2019)
60 Table 18: AKST4290 for Wet AMD (July 27, 2019)
62 Table 19: Multiple Drugs for Wet AMD (June 25, 2019)
63 Table 20: Darpin for Wet AMD (April 2, 2019)
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