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FDA set to approve expanded use for Visudyne:

This article was originally published in Clinica

Executive Summary

QLT and Novartis Ophthalmics have received an approvable letter from the US FDA to expand the use of their Visudyne photodymanic therapy. The treatment is currently approved for treating predominantly classic subfoveal choroidal neovascularisation (CNV) caused by age-related macular degeneration. The expanded indication would include treatment of CNV caused by other macular conditions, such as pathologic myopia (PA) and ocular histoplasmosis syndrome. The worldwide incidence of CNV due to PA is around 50,000 new cases per year, excluding Asia where the incidence could be even higher, claims Novartis.

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