VISUDYNE®–PROVEN EFFICACY IN TREATING NAIVE PATIENTS

With VISUDYNE® treatment in naïve patients, less progression and leakage was seen compared to placebo at Month 24¹*

With VISUDYNE® treatment in naïve patients, less progression and leakage was seen compared to placebo at Month 24¹*

*The Treatment of Age-Related Macular Degeneration With Photodynamic Therapy (TAP) investigation included 2 multicenter, double-masked, placebo-controlled, randomized clinical trials. Eligible patients had subfoveal choroidal neovascularization (CNV) lesions caused by AMD with greatest linear dimension on the retina measuring 5400 μm or less, with evidence of classic CNV and best-corrected visual acuity between 20/40 and 20/200 on the Snellen chart. Patients were randomized to receive treatment with verteporfin or a placebo. The primary outcome was the proportion of eyes with fewer than 15 letters (approximately 3 lines) of visual acuity loss at the Month 24 examination compared with baseline.¹

Progression defined as classic CNV beyond the area identified at baseline.¹

Most frequently reported adverse events (10% to 30% incidence)²

Injection site reactions such as:

  • Pain
  • Edema
  • Inflammation
  • Extravasation
  • Rashes
  • Hemorrhage
  • Discoloration

Visual disturbances including:

  • Blurred vision
  • Flashes of light
  • Decreased visual acuity
How to order VISUDYNE® for your patients

Indication

VISUDYNE® (verteporfin for injection) therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis.

Important Safety Information

  • VISUDYNE® (verteporfin for injection) is contraindicated for patients with porphyria or known hypersensitivity to any component of this preparation.
  • Standard precautions should be taken during infusion of VISUDYNE® to avoid extravasation, including but not limited to:
    • A free-flowing intravenous (IV) line should be established before starting VISUDYNE® infusion and the line should be carefully monitored.
    • Due to the possibly fragility of vein walls of some elderly patients, it is strongly recommended that the largest arm vein possible, preferably the antecubital, be used for injection.
    • Small veins in the back of the hand should be avoided.
  • Extravasation of VISUDYNE®, especially if the affected area is exposed to light, can cause severe pain, inflammation, swelling or discoloration at the injection site. If extravasation does occur, the infusion should be stopped immediately. The extravasation area must be thoroughly protected from direct light until swelling and discoloration have faded in order to prevent the occurrence of local burn, which could be severe. Cold compresses should be applied to the injection site. Oral medication for pain relief may be administered.
  • Following injection with VISUDYNE®, care should be taken to avoid exposure of skin or eyes to direct sunlight or bright indoor light for 5 days. If emergency surgery is necessary within 48 hours after treatment, as much of the internal tissue as possible should be protected from intense light.
  • Patients who experience severe decrease of vision of 4 lines or more within 1 week after treatment should not be retreated, at least until their vision completely recovers to pretreatment levels and potential benefits and risks of subsequent treatment are carefully considered by the treating physician.
  • The most frequently reported adverse events (occurring in approximately 10%-30% of patients) were injection site reactions (including pain, edema, inflammation, extravasation, rashes, hemorrhage, and discoloration), and visual disturbances (including blurred vision, flashes of light, decreased visual acuity, and visual field defects, including scotoma).

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References: 1. Bressler NM. Treatment of Age-Related Macular Degeneration With Photodynamic Therapy (TAP) Study Group. Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: two year results of 2 randomized clinical trials - TAP report. 2. Arch Ophthalmol. 2001; 119(2): 198-207. 2. VISUDYNE [package insert], Bausch & Lomb Incorporated.

Indication and Important Safety Information