Last Updated 30 December 2015
In late age-related macular degeneration (AMD), vision deficits are noticeable, often debilitating, and can be a precursor to blindness. The availability of vascular endothelial growth factor (VEGF) inhibitor therapies delivered via intravitreal injection has revolutionized the treatment of the wet form of late AMD (wet AMD), in that the majority of drug-treated patients are now able to maintain visual acuity. Current branded VEGF inhibitors will continue to dominate wet AMD treatment through the end of the 2014-2024 forecast period, but their patient share will be impacted by the anticipated launch of the first VEGF inhibitor biosimilars in the major markets under study. Adjunctive therapy is also expected to enter the wet AMD treatment algorithm—at present limited largely to monotherapy—which, along with the wet AMD emerging monotherapies, has the potential to address some unmet needs (e.g., improvements in visual outcomes, reduction in dosing frequency). Unlike for wet AMD, no therapies are approved for treating late dry AMD (i.e., geographic atrophy [GA]). The anticipated launch and subsequent uptake of first-to-market GA therapies toward the end of the study period is expected to have a dramatic effect on the AMD market, resulting in a rapid increase in the drug-treated patient population and sales.
Questions Answered in This Report:
- The GA market is set to be revolutionized by the introduction of the first therapies—Roche/Genentech’s lampalizumab and Acucela/Otsuka Pharmaceutical’s emixustat hydrochloride—to treat this disease. What are retinal specialists’ expectations for each of these emerging products? To what extent will they penetrate the diagnosed GA patient population? What is the sales potential for these therapies across the major markets under study?
- The wet AMD treatment algorithm continues to evolve following the introduction of the most-recent market entrant, aflibercept (Regeneron/Bayer HealthCare/Santen’s Eylea), as well as legislation allowing reimbursement of off-label bevacizumab in certain European markets. How is the competition between current VEGF inhibitors expected to develop over the forecast period in each of the major markets under study? How will use and sales of these agents be impacted by the launch of biosimilar versions of ranibizumab (Roche/Genentech/Novartis’s Lucentis) and aflibercept during our forecast period?
- By 2024, we forecast that three new agents will launch for wet AMD: Ophthotech/Novartis’s E-10030 (Fovista), Novartis’s RTH-258, and Allergan’s abicipar pegol (anti-VEGF DARPin). To what extent and how do physicians anticipate incorporating these novel agents into their medical practice? What impact will the uptake of these agents have on current VEGF inhibitors? Will the wet AMD treatment algorithm be transformed by the introduction of adjunctive therapy (i.e., E-10030)? Can the VEGF inhibitors RTH-258 and abicipar pegol differentiate themselves from current VEGF inhibitors?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 40 country-specific interviews with experts in the field; physician prescriber surveys.
Epidemiology: Prevalence of AMD; prevalence of early and late AMD; prevalence of dry AMD; prevalence of wet AMD; prevalence of GA; diagnosis and drug-treatment rates for wet AMD and GA.
Population segments in market forecast: Wet AMD, GA.
Emerging therapies: Phase II: 22 drugs; Phase III: 5 drugs. Coverage of 6 select Phase I products.
Nishant Kumar, M.P.H.