Ranibizumab (trade name Lucentis) is a
monoclonal antibodyfragment derived from the same parent murine antibody as bevacizumab(Avastin). It is much smaller than the parent molecule and has been affinity matured to provide stronger binding to VEGF-A. It is an anti-angiogenic that has been approved to treat the "wet" type of age-related macular degeneration(ARMD), a common form of age-related vision loss.
Ranibizumab was developed by
Genentechand is marketed in the United States by Genentech and elsewhere by Novartis[ [http://www.gene.com/gene/products/information/tgr/lucentis/factsheet.html Lucentis Fact Sheet from Genentech ] ] , under the brand name Lucentis.
Mechanism of action
Ranibizumab binds to and inhibits all subtypes of
vascular endothelial growth factorA (VEGF-A). VEGF may trigger the growth of new vessels, which may leak blood and fluid into the eye. These leaky blood vessels may contribute to macular edemaand choroidal neovascularization, resulting in the wet type of ARMD.
By blocking VEGF-A in the eye, ranibizumab may prevent and reverse vision loss caused by wet macular degeneration.
The drug is injected intravitreally (into the
vitreous humourof the eye) once a month. If monthly injections are not feasible, the regimen may be reduced to 1 injection every 3 months after the first 4 months.
However, dosing every 3 months is linked to a loss of approximately 5 letters (1 line) in visual acuity for the following 9 months as compared with dosing on a monthly basis. Large phase 3 clinical trials (MARINA and ANCHOR) which randomized patients with wet macular degeneration showed that 95% of ranibizumab-treated patients maintained visual acuity compared with 62% of those administered placebo (P < .01) at 1 year; moreover, up to 40% demonstrated an improvement in vision of at least 3 lines. Vision maintenance and loss were defined as a loss of less than 15 letters and a gain of 15 or more letters in visual acuity, respectively, as measured using the Early Treatment of Diabetic Retinopathy eye chart.
The most common side effects in clinical trials were conjunctival hemorrhage, eye pain, vitreous
floaters, increased intraocular pressure, and intraocular inflammation.
Although there is a theoretical risk for arterial thromboembolic events in patients receiving VEGF-inhibitors by intravitreal injection, the observed incidence rate was low (< 4%) and similar to that seen in patients randomized to placebo.
Serious adverse events related to the injection procedure occurred with an incidence rate of less than 1% and included
endophthalmitis, retinal detachment, and traumatic cataracts. Other serious ocular adverse events observed among ranibizumab-treated patients (incidence rate, < 2%) included intraocular inflammation and increased intraocular pressure.
* [http://www.amdsupport.ca/articles/54/1/Lucentis-Coverage-in-Canada-exists-in-Quebec-amp-Ontario/Page1.html Lucentis Coverage in Canada]
* [http://www.earthtimes.org/articles/show/9159.html Earthtimes] article notes FDA approval in June, 2006
* [http://www.medicalnewstoday.com/healthnews.php?newsid=53457 Medical News Today] cites two clinical trials in
New England Journal of Medicine
* [http://www.sciencedaily.com/upi/index.php?feed=Science&article=UPI-1-20061004-18162600-bc-us-lucentis-analysis.xml Science Daily] clarifies that although the "wet" type of macular degeneration treated by Lucentis accounts for only 10–20% of ARMD, this type causes 90% of blindness due to ARMD.
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