Visudyne (Page 4 of 4)

14.2 Pathologic Myopia

One adequate and well-controlled, double-masked, placebo-controlled, randomized study was conducted in patients with subfoveal CNV secondary to pathologic myopia. A total of 120 patients (VISUDYNE 81, placebo 39) were enrolled in the study. The treatment dosing and retreatments were the same as in the AMD studies. The difference between treatment groups statistically favored VISUDYNE at the 1-year analysis but not at the 2-year analysis for visual acuity endpoints. For the primary efficacy endpoint (percentage of patients who lost less than 3 lines of visual acuity), patients at the 1-year timepoint showed a difference of approximately 19% between treatment groups (86% for VISUDYNE patients compared to 67% for placebo patients). However, by the 2-year timepoint, the effect was no longer statistically significant (79% for VISUDYNE patients compared to 72% for placebo patients).

Based on the Verteporfin in Photodynamic Therapy in Pathologic Myopia (VIP-PM) extension study in pathologic myopia, the average number of treatments per year was 3.5 in the first year after diagnosis, 1.8 in the second, 0.4 in the third, 0.2 in the fourth and 0.1 in the fifth.

14.3 Presumed Ocular Histoplasmosis

One open-label study was conducted in patients with subfoveal CNV secondary to presumed ocular histoplasmosis. A total of 26 patients were treated with VISUDYNE in the study. The treatment dosing and retreatments for VISUDYNE were the same as the AMD studies. VISUDYNE-treated patients compare favorably with historical control data demonstrating a reduction in the number of episodes of severe visual acuity loss (>6 lines of loss).

Based on the VISUDYNE Ocular Histoplasmosis extension study in presumed ocular histoplasmosis, the average number of treatments per year was 2.9 in the first year after diagnosis, 1.2 in the second, 0.2 in the third and 0.1 in the fourth.

16 HOW SUPPLIED/STORAGE AND HANDLING

VISUDYNE (verteporfin for injection) is supplied in a single-dose glass vial with a gray bromobutyl stopper and aluminum flip-off cap. It contains a lyophilized dark green cake with 15 mg verteporfin.

NDC 0187-5600-15

Store VISUDYNE between 20°C to 25°C (68°F to 77°F).

16.1 Spills and Disposal

Spills of VISUDYNE should be wiped up with a damp cloth. Skin and eye contact should be avoided due to the potential for photosensitivity reactions upon exposure to light. Use of rubber gloves and eye protection is recommended. All materials should be disposed of properly.

16.2 Accidental Exposure

Because of the potential to induce photosensitivity reactions, it is important to avoid contact with the eyes and skin during preparation and administration of VISUDYNE. Any exposed person must be protected from bright light [see Warnings and Precautions (5.1)].

17 PATIENT COUNSELING INFORMATION

Advise patients who receive VISUDYNE that they will become temporarily photosensitive after the infusion. Patients should be advised to wear a wristband to remind them to avoid direct sunlight for 5 days. During that period, patients should be advised to avoid exposure of unprotected skin, eyes or other body organs to direct sunlight or bright indoor light. Sources of bright light include, but are not limited to, tanning salons, bright halogen lighting and high power lighting used in surgical operating rooms or dental offices. Prolonged exposure to light from light-emitting medical devices such as pulse oximeters should also be avoided for 5 days following VISUDYNE administration.

If treated patients must go outdoors in daylight during the first 5 days after treatment, they should be advised to protect all parts of their skin and their eyes by wearing protective clothing and dark sunglasses. UV sunscreens are not effective in protecting against photosensitivity reactions because photoactivation of the residual drug in the skin can be caused by visible light.

Patients should be advised to not stay in the dark and should be encouraged to expose their skin to ambient indoor light, as it will help inactivate the drug in the skin through a process called photobleaching.

Following VISUDYNE treatment, patients should be advised that they may develop visual disturbances such as abnormal vision, vision decrease, or visual field defects that may interfere with their ability to drive or use machines. Patients should be advised to not drive or use machines as long as these symptoms persist.

Distributed by:
Bausch + Lomb, a division of Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Manufactured by:
Alcami Carolinas Corporation
Charleston, SC 29405 USA
VISUDYNE is a registered trademark of CHEPLAPHARM ARZNEIMITTEL GMBH used under license.
Other product/brand names are trademarks of the respective owners.
© 2021 Bausch & Lomb Incorporated or its affiliates

9589702

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 0187-5600-15

Rx only

Visudyne^®
(verteporfin
for injection)
Sterile
15 mg
1 Single-Use Vial

VISUDYNE verteporfin for injection injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-5600 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VERTEPORFIN (VERTEPORFIN) VERTEPORFIN 15 mg

Inactive Ingredients Ingredient Name Strength ASCORBYL PALMITATE BUTYLATED HYDROXYTOLUENE LACTOSE, UNSPECIFIED FORM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0187-5600-15 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021119 04/12/2000

Labeler — Bausch Health US LLC (831922468)

Establishment
Name	Address	ID/FEI	Operations
Par Sterile Products LLC (formerly JHP		808402890	MANUFACTURE (0187-5600), PACK (0187-5600)

Establishment
Name	Address	ID/FEI	Operations
Alcami Carolinas Corporation		832394733	MANUFACTURE (0187-5600), PACK (0187-5600)

Revised: 07/2021 Bausch Health US LLC