Ranibizumab

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Ranibizumab
Monoclonal antibody
Type Fab fragment
Source Humanized (from mouse)
Target Vascular endothelial growth factor A (VEGF-A)
Clinical data
Trade names Lucentis, others
Biosimilars Ranibizumab-nuna, [1] Ranibizumab-eqrn, [2] Byooviz, [1] [3] Cimerli, [2] Ranivisio, [4] Susvimo, [5] Ximluci [6]
AHFS/Drugs.com Monograph
MedlinePlus a607044
License data
Pregnancy
category
Routes of
administration 		Intravitreal injection
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life Approx. 9 days [11]
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
Formula C2158H3282N562O681S12
Molar mass 48379.97 g·mol−1
 X mark.svgNYes check.svgY  (what is this?)    (verify)

Ranibizumab, sold under the brand name Lucentis among others, is a monoclonal antibody fragment (Fab) created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic [13] that is approved to treat the "wet" type of age-related macular degeneration (AMD, also ARMD), diabetic retinopathy, and macular edema due to branch retinal vein occlusion or central retinal vein occlusion.

Contents

Ranibizumab was developed by Genentech and marketed by them in the United States, and elsewhere by Novartis, [14] under the brand name Lucentis. [11] [14] [15] Ranibizumab (Lucentis) was approved for medical use in the United States in June 2006, [15] [11] and in the European Union in January 2007.

Medical uses

In the United States, ranibizumab is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. [11] [16]

In the European Union, ranibizumab is indicated for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion, and visual impairment due to choroidal neovascularisation. [12] [3] [4]

It is often used for age-related wet macular degeneration. [17] Its effectiveness is similar to that of bevacizumab [18] [19] and aflibercept. [20] A 2023 systematic review update found that while ranibizumab and bevacizumab provide similar functional outcomes in diabetic macular edema, there is low-certainty evidence suggesting that ranibizumab is more effective in reducing central retinal thickness than bevacizumab. [21]

Side effects

A 2014 Cochrane review did not find a difference between bevacizumab and ranibizumab in deaths or total severe side effects when used for macular degeneration. [22] There, however, was not a lot of evidence, and thus this conclusion is not that certain. [22]

Ranibizumab does appear to result in a lower risk of stomach and intestinal problems. [22] It is also associated with a low rate of eye related side effects. [23]

The most common side effects in clinical trials were conjunctival haemorrhage, eye pain, vitreous floaters, increased intraocular pressure, and intraocular inflammation.

Although there is a theoretical risk for arterial thromboembolic events in people receiving VEGF-inhibitors by intravitreal injection, the observed incidence rate was low (< 4%) and similar to that seen with 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 < 1%) included intraocular inflammation and blindness. [24]

Interactions

No significant interactions are known. [25]

Pharmacology

Ranibizumab is a monoclonal antibody that inhibits angiogenesis by inhibiting vascular endothelial growth factor A, a mechanism similar to that of Bevacizumab. [26]

Society and culture

Economics

Its effectiveness is similar to that of bevacizumab. [18] [27] Its rates of side effects also appear similar. [22] However, ranibizumab typically costs $2,000 a dose, while the equivalent dose of bevacizumab typically costs $50. [28] [29] [30] [31]

In November 2010, The New York Times reported that Genentech began offering secret rebates to about 300 ophthalmologists in an apparent inducement to get them to use more ranibizumab rather than their less expensive bevacizumab. This may have been in anticipation of the results of the CATT clinical trial, [29] which was sponsored by the National Eye Institute, and compared the relative safety and efficacy of ranibizumab and bevacizumab in treating AMD. In 2008, bevacizumab cost Medicare only $20 million for about 480,000 injections, while ranibizumab cost Medicare $537 million for only 337,000 injections. [32] A small study showed no superior effect of ranibizumab versus bevacizumab in direct comparison. [33] The initial results of the larger Comparison of Age-related Macular Degeneration Treatments Trials (CATT) trial were published in the New England Journal of Medicine in May 2011. [29] The trial showed that the two drugs "had equivalent effects on visual acuity when administered according to the same schedule;" however, serious adverse events were more common in the bevacizumab arm of the trial.

The results of several subsequent head-to-head trials of the two anti-VEGF treatments were later published, and the overall results reinforced CATT's findings. The two therapies performed equally at restoring visual acuity according to a 2012 meta-analysis, [34] and also in the IVAN trial, alone and in the investigators' meta-analysis pooling its own results with CATT's. [35] A 2012 meta-analysis focused specifically on safety issues concluded that the rates of several adverse events were higher with bevacizumab, although the absolute rates of ocular serious adverse events were low with both therapies: ocular adverse events were about 2.8 times as frequent with bevacizumab than with ranibizumab, and "The proportion of patients with serious infections and gastrointestinal disorders was also higher." The authors concluded that "clinicians and patients should continue to carefully weigh-up the benefits and harms when choosing between the two treatment options. We also emphasize the need for studies that are powered not just for efficacy, but for defined safety outcomes based on the signals detected in this systematic review". [27]

Biosimilars

Byooviz was approved for medical use in the European Union in August 2021. [3] [36]

Ranibizumab-nuna (Byooviz) was approved for medical use in the United States in September 2021. [1] [16]

Susvimo was approved for medical use in the United States in October 2021. [5] [37]

In India, Lupin Limited received marketing approval for its biosimilar of Ranibizumab. [38]

In June 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ranivisio, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular edema or choroidal neovascularization, and proliferative diabetic retinopathy. [39] The applicant for this medicinal product is Midas Pharma GmbH. [39] Ranivisio was approved for medical use in the European Union in August 2022. [4] [40]

Ranibizumab-eqrn (CIMERLI®) was approved for medical use in the United States in August 2022. [2] [41]

In September 2022, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ximluci, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularization. [42] The applicant for this medicinal product is STADA Arzneimittel AG. [42] Ximluci was approved for medical use in the European Union in November 2022. [6] [43]

In November 2023, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Rimmyrah, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularization. [44] The applicant for this medicinal product is QILU PHARMA SPAIN S.L. [44] Rimmyrah is a biosimilar medicinal product that is highly similar to the reference product Lucentis (ranibizumab), which was authorized in the EU in January 2007. [44]

In January 2024, Sandoz signed an agreement to acquire ranibizumab-eqrn, the biosimilar version of ranibizumab branded as CIMERLI®* from Coherus BioSciences, Inc. for an upfront cash purchase payment of USD 170 million. [45] [46] [47]

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Retinopathy is any damage to the retina of the eyes, which may cause vision impairment. Retinopathy often refers to retinal vascular disease, or damage to the retina caused by abnormal blood flow. Age-related macular degeneration is technically included under the umbrella term retinopathy but is often discussed as a separate entity. Retinopathy, or retinal vascular disease, can be broadly categorized into proliferative and non-proliferative types. Frequently, retinopathy is an ocular manifestation of systemic disease as seen in diabetes or hypertension. Diabetes is the most common cause of retinopathy in the U.S. as of 2008. Diabetic retinopathy is the leading cause of blindness in working-aged people. It accounts for about 5% of blindness worldwide and is designated a priority eye disease by the World Health Organization.

<span class="mw-page-title-main">Diabetic retinopathy</span> Medical condition

Diabetic retinopathy, is a medical condition in which damage occurs to the retina due to diabetes mellitus. It is a leading cause of blindness in developed countries.

The National Eye Institute (NEI) is part of the U.S. National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services. The mission of NEI is "to eliminate vision loss and improve quality of life through vision research." NEI consists of two major branches for research: an extramural branch that funds studies outside NIH and an intramural branch that funds research on the NIH campus in Bethesda, Maryland. Most of the NEI budget funds extramural research.

<span class="mw-page-title-main">Macular edema</span> Medical condition

Macular edema occurs when fluid and protein deposits collect on or under the macula of the eye and causes it to thicken and swell (edema). The swelling may distort a person's central vision, because the macula holds tightly packed cones that provide sharp, clear, central vision to enable a person to see detail, form, and color that is directly in the centre of the field of view.

<span class="mw-page-title-main">Macular degeneration</span> Medical condition associated with vision loss

Macular degeneration, also known as age-related macular degeneration, is a medical condition which may result in blurred or no vision in the center of the visual field. Early on there are often no symptoms. Over time, however, some people experience a gradual worsening of vision that may affect one or both eyes. While it does not result in complete blindness, loss of central vision can make it hard to recognize faces, drive, read, or perform other activities of daily life. Visual hallucinations may also occur.

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<span class="mw-page-title-main">Pegaptanib</span> Drug to treat macular degeneration

Pegaptanib sodium injection is an anti-angiogenic medicine for the treatment of neovascular (wet) age-related macular degeneration (AMD). It was discovered by NeXstar Pharmaceuticals and licensed in 2000 to EyeTech Pharmaceuticals, now OSI Pharmaceuticals, for late stage development and marketing in the United States. Gilead Sciences continues to receive royalties from the drugs licensing. Outside the US pegaptanib is marketed by Pfizer. Approval was granted by the U.S. Food and Drug Administration (FDA) in December 2004.

<span class="mw-page-title-main">Choroidal neovascularization</span> Creation of new blood vessels in the choroid layer of the eye

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<span class="mw-page-title-main">Intravitreal injection</span> Method of administration of drugs into the eye by injection with a fine needle

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References

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  47. ↑ MarketScreener (22 January 2024). "Sandoz: acquisition of ophthalmology biosimilar -January 22, 2024 at 01:49 am EST | MarketScreener". www.marketscreener.com. Retrieved 22 January 2024.
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