Visudyne Recall

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Questions & Answers

Side Effects & Adverse Reactions

Following injection with VISUDYNE (verteporfin for injection), care should be taken to avoid exposure of skin or eyes to direct sunlight or bright indoor light for 5 days. In the event of extravasation during infusion, the extravasation area must be thoroughly protected from direct light until the swelling and discoloration have faded in order to prevent the occurrence of a local burn which could be severe. 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 the potential benefits and risks of subsequent treatment are carefully considered by the treating physician.

Use of incompatible lasers that do not provide the required characteristics of light for the photoactivation of VISUDYNE could result in incomplete treatment due to partial photoactivation of VISUDYNE, overtreatment due to overactivation of VISUDYNE, or damage to surrounding normal tissue.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


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.

There is insufficient evidence to indicate VISUDYNE for the treatment of predominantly occult subfoveal choroidal neovascularization.


There is currently no drug history available for this drug.

Other Information

VISUDYNE® (verteporfin for injection) is a light activated drug used in photodynamic therapy. The finished drug product is a lyophilized dark green cake. Verteporfin is a 1:1 mixture of two regioisomers (I and II), represented by the following structures:

Image from Drug Label Content

The chemical names for the verteporfin regioisomers are:

9-methyl (I) and 13-methyl (II) trans-(±)-18-ethenyl-4,4a-dihydro-3,4-bis(methoxycarbonyl)-4a,8,14,19-tetramethyl-23H, 25H-benzo[b]porphine-9,13-dipropanoate

The molecular formula is C41H42N4O8 with a molecular weight of approximately 718.8.

Each mL of reconstituted VISUDYNE contains:

ACTIVE: Verteporfin, 2 mg

INACTIVES: Lactose, egg phosphatidylglycerol, dimyristoyl phosphatidylcholine, ascorbyl palmitate and butylated hydroxytoluene

Visudyne Manufacturers

  • Qlt Inc.
    Visudyne (Verteporfin) Injection, Powder, Lyophilized, For Solution [Qlt Inc.]
  • Qlt Ophthalmics, Inc.
    Visudyne (Verteporfin For Injection) Injection, Powder, Lyophilized, For Solution [Qlt Ophthalmics, Inc.]
  • Valeant Pharmaceuticals North America Llc
    Visudyne (Verteporfin For Injection) Injection, Powder, Lyophilized, For Solution [Valeant Pharmaceuticals North America Llc]

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