Wet AMD|Safety|Adverse Event Rates

Ocular adverse events


Most common ocular adverse events occurring in >15% of wet AMD patients*

Adverse event LUCENTIS Control
Conjunctival hemorrhage 77%-43% 66%-29%
Eye pain 37%-17% 33%-11%
Vitreous floaters 32%-3% 10%-3%
Increased intraocular pressure 25%-8% 8%-3%
Vitreous detachment 22%-7% 22%-13%
Intraocular inflammation 18%-5% 11%-3%
Cataract 20%-5% 16%-6%
Foreign body sensation 19%-6% 14%-6%
Eye irritation 19%-4% 20%-6%
Increased lacrimation 17%-3% 16%-0%


Key injection-related serious ocular adverse events1,3,4

MARINA
(Year 2)		 ANCHOR
(Year 2)		 PIER
(Year 1)
Adverse event Sham
(n=236)		 LUCENTIS
(n=477)		 Verteporfin PDT
(n=143)		 LUCENTIS
(n=277)		 Sham
(n=63)		 LUCENTIS
(n=120)
Endophthalmitis 0 1.0% (5) 0 1.1% (3) 0 0
Rheg. retinal detachment 0.4% (1) 0 0.7% (1) 0.7% (2) 0 0
Iatrogenic traumatic cataract 0 0.2% (1) 0 0 0 0


Non-ocular adverse events


Antiplatelet Trialists' Collaboration (APTC)-defined arterial thromboembolic events (ATEs) in LUCENTIS clinical studies1,2

MARINA
(Year 2)		 ANCHOR
(Year 2)		 PIER
(Year 1)
Adverse event Sham
(n=236)		 LUCENTIS
(n=477)		 Verteporfin PDT
(n=143)		 LUCENTIS
(n=277)		 Sham
(n=63)		 LUCENTIS
(n=120)
Vascular death 1.7% (4) 1.3% (6) 2.1% (3) 1.4% (4) 0 0
Nonfatal myocardial infarction 1.7% (4) 1.9% (9) 1.4% (2) 2.2% (6) 0 0
Nonfatal ischemic stroke 0.8% (2) 1.7% (8) 1.4% (2) 1.1% (3) 0 0
Nonfatal hemorrhagic stroke 0 0.2% (1) 0 0 0 0
Total patients experiencing ATEs† 3.8% (9) 4.6% (22) 4.2% (6) 4.7% (13) 0 0
  • The MARINA, ANCHOR, and PIER studies were rigorously designed and did not exclude patients with a history of cardiovascular events1
  • ATE rates in LUCENTIS clinical studies were consistent with the annual rates of myocardial infarction and stroke for patients with neovascular AMD reported in several population-based epidemiology studies1,5
    • Data based on analyses of 5% Medicare and healthcare utilization administration claims (LabRx) databases in 2 cross-sectional cohort studies


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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