Visudyne gets FDA nod for two additional indications

ATLANTA — Visudyne (verteporfin for injection, Novartis Ophthalmics and QLT Therapeutics) has received Food and Drug Administration approval for the treatment of predominantly classic subfoveal choroidal neovascularization (CNV) due to pathologic myopia and for the treatment of presumed ocular histoplasmosis.

The compound was first approved by the FDA in April 2000 for the treatment of classic CNV due to age-related macular degeneration (AMD).

In phase 3 studies in patients with CNV due to pathologic myopia, Visudyne therapy stabilized or improved vision (defined as a loss of fewer than 8 letters on a standard eye chart) in 72% of patients vs. 44% on placebo at month 12.

In an open-label safety study involving 26 patients with ocular histoplasmosis, visual acuity improved by an average of more than 1 line on a standard eye chart at 12 months (6.7 letters on a standard eye chart) with 28% of patients experiencing a visual acuity improvement of 3 lines (15 letters) or more. Visual acuity decreased by fewer than 3 lines of vision in 88% of patients during the same time period.

CNV in pathologic myopia is characterized by abnormal blood vessels that grow under the center of the retina as a result of an abnormal elongation of the eye associated with severe myopia. It generally occurs among people older than 30 years of age. The worldwide incidence of CNV due to pathologic myopia is estimated to be 50,000 new cases per year.

In presumed ocular histoplasmosis, CNV develops from the margin of retinal scars in the back of the eye, which are caused by a fungal infection of the retina. It can lead to severe, irreversible vision loss. The condition is caused by inhaling the fungus Histoplasma capsulatum, found predominantly in the mid-central United States. The fungus generally remains in a dormant stage but tends to become more active when a person's immune system is compromised.