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Wet AMD|Dosing|Treatment Recommendations

4 initial monthly doses are proven to result in early improvement

To achieve results comparable with those seen in MARINA and ANCHOR, monthly dosing of LUCENTIS is recommended¹
Some clinical trial patients with wet AMD who experienced a >15-letter gain with 4 initial monthly doses maintained or continued to demonstrate a significant improvement in visual acuity through year 2 with consistent dosing

If wet AMD patients gain letters after 4 monthly injections, they may still be improving—consistent dosing should be considered; if patients lose letters after 4 monthly injections, consistent dosing should be considered¹

Some clinical trial patients who experienced an initial loss of <15 letters also maintained vision or demonstrated a gain by year 1
There were a small number of clinical trial patients who experienced a loss of >15 letters over the course of treatment

Persistent, continuous monitoring is critical to determining the appropriate treatment schedule to optimize outcomes¹

Monthly dosing of LUCENTIS is recommended to achieve similar results to those seen in pivotal clinical studies through year 2
Monitor regularly to prevent the risk of progressive vision loss

Patients with wet AMD vary in their treatment time to response and can experience periods of gain and loss within the course of treatment.²

If monthly dosing is not feasible, less frequent dosing may be considered after 4 initial monthly doses; however, quarterly dosing has been shown to result in some loss of benefit¹

The PIER trial demonstrated vision improvement (up to 5 letters) during initial monthly dosing, and VA returned to baseline with subsequent mandated quarterly dosing¹

PIER: Phase IIIb, multicenter (45 sites), randomized, double-masked, sham-controlled study in 184 patients with choroidal neovascularization (CNV) lesions with or without a classic component.

INDICATION

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

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

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, retinal detachment, and iatrogenic traumatic cataract. 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).

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.

In neovascular (wet) age-related macular degeneration clinical trials, most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, vitreous detachment, and intraocular inflammation. Most common non-ocular side effects included nasopharyngitis, headache, arthralgia, and bronchitis.

In macular edema following retinal vein occlusion clinical trials, most common ocular side effects included conjunctival hemorrhage, eye pain, and maculopathy. Most common non-ocular side effects included nasopharyngitis, headache, influenza, and sinusitis.

For additional safety information, please see LUCENTIS full prescribing information

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