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VISUDYNE® EFFECTIVELY REDUCES LEAKAGE AND NEOVASCULAR LESIONS1

Retinal imaging is key to detecting persistent fluid and assessing
treatment progress with VISUDYNE®

VISUDYNE® PATIENTS HAD FEWER LARGE LESIONS* AT 24 MONTHS2

~50% of patients post-VISUDYNE® therapy had lesions of ≤6 macular photocoagulation study (MPS) disc areas at month 242

LESION SIZE AT 24 MONTHS
(MPS DISC AREAS)
AVERAGE NUMBER OF VISUDYNE® TREATMENTS PER YEAR AFTER WET AMD† DIAGNOSIS1
YEAR 1 YEAR 2 YEAR 3
3.5 2.4 1.3

Less Disease Progression

Disease progression was observed in 23% of VISUDYNE® patients, compared to the 54% recorded in the placebo group (n=402 vs n=207, respectively)2

Less Leakage

51% of VISUDYNE® patients had no vascular leakage, compared to 29% of patients on placebo (n=361 vs n=187, respectively)2

Study Design >

MOST FREQUENTLY REPORTED ADVERSE EVENTS
(10% TO 30% INCIDENCE)1

Injection site reactions1 such as:

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

Visual disturbances1 including:

  • Blurred vision
  • Flashes of light
  • Decreased visual acuity
SEE CASE STUDIES
AMD=age-related macular degeneration, BVN=blood vessel neovascularization, CNV=choroidal neovascularization, ICGA=indocyanine green angiography, SD-OCT=spectra-domain optical coherence tomography.
†The patients who completed the TAP study were eligible to enroll in the open-label extension study for an additional 3 years.2,3

Indication

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

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. Necrosis at the injection site following extravasation has been reported. 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.
  • Cases of anaphylactic reactions have been reported. Immediately discontinue VISUDYNE and initiate appropriate therapy if anaphylactic or other serious allergic reactions occur during or following therapy.
  • 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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Click here for full Prescribing Information for VISUDYNE®.

Indication and Important Safety Information

References: 1. VISUDYNE [package insert]. Bridgewater, NJ: Bausch & Lomb Incorporated. 2. 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. 3. Kaiser PK; Treatment of Age-Related Macular Degeneration With Photodynamic Therapy (TAP) Study Group. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: 5-year results of two randomized clinical trials with an open-label extension: TAP report no. 8. Graefes Arch Clin Exp Ophthalmol. 2006;244(9):1132-1142.