More than 50% of blindness in developed nations is due to age-related macular degeneration (AMD) and the incidence is expected to rise as the elderly population continues to increase.
In the United States alone, there are about 2 million people suffering from the wet form of AMD associated with abnormal blood vessels with over 200,000 new cases each year.
Current treatments for AMD include anti-VEGF therapy which is beneficial in approximately 40% of patients. The lead anti-VEGF ophthalmic product is an antibody fragment with United States sales of US$875 million in 2008. Patients may require intra-ocular injections as often as once a month for six to 24 months at a cost of approximately US$2,000 per injection.
Preclinical studies have shown that a single injection of Mesoblast’s adult stem cell technology may be synergistic to anti-VEGF treatment, particularly if the potential to restore eyesight is improved. A treatment that avoids repeated injections into the eye would have a major market advantage.
Diabetic Macular Edema
Mesoblast is also targeting the most common cause of visual loss in diabetics, a condition called diabetic macular edema or edema (DME) which complicates underlying diabetic eye disease.
The prevalence of DME among United States diabetics is nearly 30% in adults who have had diabetes for 20 years or more. The estimated annual incidence of new cases of DME is 75,000.
The market for treating DME has been estimated at 335,000 procedures each year in the United States increasing at a 2.8% rate p.a.
Preclinical trials have shown that a single injection of Mesoblast’s proprietary stem cells are highly effective for the treatment of leaky blood vessels in the eye, the major cause of vision loss in patients with wet age-related macular degeneration and diabetic retinopathy. This one time administration holds the promise for a sustained effect and superior outcome to standard of care anti-VEGF therapies and represents an additional major market opportunity.