LUCENTIS Sampling Program

The new LUCENTIS Sampling Program is designed to help you:

Start trials on new wet AMD patients or patients with macular edema following RVO to see if LUCENTIS^® (ranibizumab injection) is right for them

Treat newly diagnosed wet AMD patients or patients with macular edema following RVO on the same day

Before their next treatment, consider conducting a benefits investigation; Lucentis Access Solutions™ is here to help

How to Enroll and Request LUCENTIS Samples:

A 6 Month Sample Request Form will be e-mailed to you to complete; fax it in to 877-329-6737

Upon receipt of samples, submit an Acknowledgment of Contents through the LUCENTISDirect.com website

Each month, log on to LUCENTISDirect.com to confirm or decline your next shipment

If you do not have a LUCENTIS Direct™ account, you can set up an account on the site or call one of our Customer Relationship Specialists at 800-963-1778.

Samples may not be sold, purchased, traded, returned for credit, or utilized to seek reimbursement.

LUCENTIS^® (ranibizumab injection) is indicated for the treatment of patients with:

• Neovascular (Wet) Age-Related Macular Degeneration
• Macular Edema Following Retinal Vein Occlusion

IMPORTANT SAFETY INFORMATION

LUCENTIS is contraindicated in patients with ocular or periocular infections or hypersensitivity to ranibizumab or any of the excipients in LUCENTIS.

WARNINGS AND PRECAUTIONS
Intravitreal injections, including those with LUCENTIS, have been associated with endophthalmitis and retinal detachment. Proper aseptic injection technique should always be utilized when administering LUCENTIS. Patients should be monitored during the week following the injection to permit early treatment, should an infection occur.

Increases in intraocular pressure (IOP) have been noted within 60 minutes of intravitreal injection. IOP and perfusion of the optic nerve head should be monitored and managed appropriately.

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LUCENTIS clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).

Neovascular Age-Related Macular Degeneration
The ATE rate in the three controlled neovascular AMD studies during the first year was 1.9% (17 out of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS compared with 1.1% (5 out of 441) in patients from the control arms. In the second year of studies AMD-1 and AMD-2, the ATE rate was 2.6% (19 out of 721) in the combined group of LUCENTIS-treated patients compared with 2.9% (10 out of 344) in patients from the control arms.

In a pooled analysis of 2-year controlled studies (AMD-1, AMD-2 and a study of LUCENTIS used adjunctively with verteporfin photodynamic therapy), the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 out of 484) in patients treated with 0.5 mg LUCENTIS compared to 1.1% (5 out of 435) in patients in the control arms (odds ratio 2.2 (95% confidence interval (0.8-7.1))).

Macular Edema Following Retinal Vein Occlusion
The ATE rate in the two controlled RVO studies during the first six months was 0.8% in both the LUCENTIS and control arms of the studies (4 out of 525 in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS and 2 out of 260 in the control arms). The stroke rate was 0.2% (1 out of 525) in the combined group of LUCENTIS-treated patients compared to 0.4% (1 out of 260) in the control arms.

ADVERSE EVENTS
Serious adverse events related to the injection procedure occurring in <0.1% of intravitreal injections included endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract. Other serious ocular events occurring in <2% of patients included intraocular inflammation with or without hypersensitivity and increased IOP.

In neovascular (wet) age-related macular degeneration clinical trials, most common ocular side effects included conjunctival hemorrhage, eye pain, and vitreous floaters. Most common non-ocular side effects included nasopharyngitis, headache, respiratory and urinary tract infections. In macular edema following retinal vein occlusion clinical trials, most common ocular side effects included conjunctival hemorrhage, retinal exudates, eye pain, and retinal vascular disorders. Most common non-ocular side effects included nasopharyngitis, sinusitis and respiratory tract infections.

As with all therapeutic proteins, there is the potential for an immune response in patients treated with LUCENTIS. The clinical significance of immunoreactivity to LUCENTIS is unclear at this time.

For additional safety information, please see LUCENTIS full prescribing information >>.