Research Overview
Need to Prove Unique Benefits Challenging Wet AMD Therapeutics Market
While instances in age-related macular degeneration (AMD), diabetic
retinopathy (DR), and diabetic edema (DME) are increasing at an alarming rate,
the available therapies are limited. Pharmaceuticals companies are only now
beginning to develop therapeutics to treat back-of-the-eye conditions that are
aggravating the financial, emotional, and physical burden on American society.
Wet AMD - the most aggressive form of AMD and visual impairment ? is attracting
attention due to advances in therapeutic technology such as angiogenesis
inhibitors, gene vaccines, and vascular endothelial growth factor (VEGF). The
key challenge for wet AMD therapeutics is to demonstrate statistically
significant benefits over existing treatments in all its sub segments. This is
likely to garner reimbursement status from the Centers for Medicare &
Medicaid Services (CMS) and enable the new pipeline biologic therapies to
penetrate the market.
This Frost & Sullivan research service looks at the competitive
environment inherent in the AMD, DR, and DME markets. It covers disease
etiology, patient forecast numbers, current therapeutic options, in-depth
analysis of emerging therapies, revenue forecasts, and comparative product
analysis.
Innovative Angiogenesis Inhibitors in Late Stage Clinical Development
Causing Excitement in Market
The wet AMD therapeutic sector, by itself, is expected to be worth $1.84
billion in 2010. With many innovative angiogenesis inhibitors in late-stage
clinical development with new drug applications (NDAs) soon to be filed, this
segment is on the brink of a revolution whereby patients can gain access to
vision-saving therapies. Improving on the conventional therapies currently in
use, the new treatments are likely to not only prevent the progression of
disease, but also cause the swollen blood vessels to regress ? Thereby restoring
lost visual capabilities.
CMSf Change in Reimbursement Coverage Bodes Well For New Therapies
Of the two major subtypes of wet AMD ? Predominantly classic and minimally
classic or occult ? Available treatments were FDA-approved only for the
predominantly classic subtype. However, a change in reimbursement coverage
instituted by the CMS has expanded the reimbursement of Visudyne into occult and
minimally classic subtypes with lesions smaller than four disc areas.
The expansion of coverage is expected to be a key driver for new therapies
entering the market. This is because many of their clinical results demonstrate
greater therapeutic response in all subtypes of wet AMD regardless of lesion
size, and therefore, are most likely to be able to obtain the highly sought
after reimbursement status. Reimbursement is extremely important since all of
the patients affected by AMD are over the age of 65, and therefore, qualify for
Medicare coverage.
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