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“Other” Eye Conditions Macular Degeneration Retinal Vascular Occlusions (RVO)

Retina Specialists Warnings of Beovu

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In a recent meeting of the American Society of Retina Specialists (ASRS), a warning was issued to its members regarding possible adverse effects of Beovu (brolucizumab).

BEOVU is an anti-VEGF medication recently FDA approved for the treatment of wet macular degeneration.  The parent company Novartis received FDA approval for the drug in October 2019 for the treatment of wet macular degeneration.

Other anti-VEGF medications currently used to treat wet macular degeneration include:

  • Macugen (pegaptanib)
  • Avastin (bevacizumab)
  • Lucentis (ranibizumab)
  • Eylea (aflibercept)

The efficacy of Beovu has been comparable to Eylea, another anti-VEGF medication also used to treat wet macular degeneration.  Other anti-VEGF medications include Avastin and Lucentis. Though the dosing and use of these drugs varies among retina specialists, most of these injections need to be repeated every 4-6 weeks and often for a year or longer.

Unlike other antiVEGF medications, Beovu has the potential to be used with an extended 3 month dosing schedule, thus potentially reducing the number of visits to the doctor’s office.

Letter of Warning

In the letter addressed to its members, the ASRS noted possible side effects not previously observed in clinical trial data.

14 cases of an unusual type of retinal vasculitis (inflammation) following injection of Beovu have been reported since the drug gained FDA approval.  In 11 of these patients, severe vision loss was sustained.

Retinal vasculitis is not a known side effect of Eylea, another anti-VEGF medication also used for the treatment of wet macular degeneration.  In the FDA trials, the safety and efficacy of Beovu was directly compared to Eylea.

Retinal vasculitis is not a common condition. There is no common denominator between the 14 patients.

Novartis Response

Novartis maintains that Beovu is safe and stands behind the safety and efficacy data submitted to the FDA before receiving approval in October.  In addition, they are engaging an external safety committee to review these cases of occlusive vasculitis reported since receiving FDA approval.

 

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Categories
Macular Degeneration Retinal Vascular Occlusions (RVO) Treatments

Beovu for Wet Macular Degeneration

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A new drug, Beovu (brolucizumab), is now FDA approved for the treatment of wet macular degeneration.  Beovu, manufactured by Novartis, is an anti-VEGF injection. Like other anti-VEGF injections, Beovu may be used in patients requiring multiple treatments, but at a more extended dosing schedule.

Macular Degeneration

There are two types of macular degeneration:  wet and dry.  

Dry macular degeneration usually progresses quite slowly (over months to years) and leads to minimal to moderate vision.  There is no treatment for dry macular degeneration.

Wet macular degeneration can be more aggressive causing loss of vision over days to weeks.  Abnormal blood vessels (neovascular blood vessels) can develop within the layers of the retina.  These vessels lead and bleed, hence the term “wet.”  

Anti-VEGF medications selectively target the neovascular tissue thereby limiting damage to the adjacent normal retinal tissue.

If caught in time, vision loss from wet macular degeneration can be improved.  Treatments are then aimed at reducing the chances of recurrence.

Anti-VEGF Treatments

All anti-VEGF treatments decrease leakage and can cause regression of the neovascular tissue.  All can be repeated as often as monthly.

Other anti-VEGF injections include:  Avastin, Lucentis, Eylea and Macugen.

Anti-VEGF injections have become the mainstay of treating diabetic retinopathy, retinal vascular occlusions and wet ARMD.  All are similar in that both leakage and bleeding can occur.

BEOVU – Extended Dosing

Beovu was compared to Eylea and was found to be “non-inferior” with respect to vision improvement.  Beovu, however, is approved for a 3 month dosing schedule and may represent a unique advantage for retina specialists’ use compared to other anti-VEGFs on the market.

In short, Beovu may work as well as other anti-VEGFs, but may be injected every 12 weeks instead of every 4-6 months.

Though FDA approved, it is likely that use of Beovu will be slow as retina specialists identify exactly which patients will benefit the most from this new treatment for wet macular degeneration. 

 

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Categories
Retinal Vascular Occlusions (RVO)

Central Retinal Artery Occlusions | CRAO

Retinal Vascular Occlusions

Central Retinal Artery OcclusionCRAO, or central retinal artery occlusions, occur when the entire blood supply to the retina is lost due to a blockage of the central retinal artery in the eye.  CRAO causes sudden and painless loss of vision as with other types of retinal vascular occlusions (RVO).

Unlike occlusions of retinal veins (central retinal vein occlusions and branch retinal vein occlusion), CRAO may be a sign of serious systemic disease.  Diagnosis of an artery occlusion should be coordinated with a systemic evaluation of cardiovascular disease.

There are 4 types of retinal vascular occlusions (RVO):

  1. BRVO = Branch retinal vein occlusion
  2. CRVO = Central retinal vein occlusion
  3. BRAO = Branch retinal artery occlusion
  4. CRAO = Central retinal artery occlusion

Symptoms of CRAO

“Central” retinal artery occlusion almost always involves the entire retina.  Profound vision loss occurs due to involvement of the entire retina usually to include the macula.  A small percentage of patients have an additional “cilio-retinal” artery which may allow the macula (provides central vision) to be spared.  This accessory artery is normally present in about 10-15% of all patients.

The hallmark of CRAO, as with other retinal vascular occlusions, is sudden painless loss of vision.

Embolus Causes Artery Occlusions

A small particle of cholesterol, fat or calcium can break off from the carotid arteries or a diseased heart and plug the retinal artery.  This particle is called an embolus. Rarely, clumps of platelets can also form an embolus.

An embolus can travel into the eye and cause the entire artery to get plugged.  The same mechanism can occur with stroke and heart attack. In the eye, the entire retina loses oxygen by the lack of blood supply and vision is lost.

Treatment of CRAO

Vision is generally permanent in cases of CRAO.

Immediate treatment is focused on dislodging the embolus and, in theory, restoring blood circulation.  Ideally, blood flow should be restored with 24 hours after the occlusion starts.

Most patients are not seen until well after the initial 24 hours.

Systemic Evaluation

Though little can be done to improve the vision loss, follow up is important to prevent complications from loss of blood supply.  As with all forms of vascular occlusions, complications from neovascular glaucoma can develop and lead to a very painful condition.

Though vision loss is usually permanent, patients must be aware that complications can occur from any type of retinal vascular occlusion.  All patients with RVO (retinal vascular occlusions) are at risk for developing neovascular glaucoma, a very painful type of glaucoma.

Patients with either type of artery occlusion are at increased risk for heart attack or stroke.  Patients with either BRAO or CRAO should have an evaluation for risk of developing heart attack or stroke by their PCP or cardiologist.

 

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Categories
Retina Retinal Vascular Occlusions (RVO) Uncategorized

Retinal Vascular Occlusions | RVO

Retinal Vascular Occlusions

Both arteries and veins of the retina can become blocked or occluded.  Each type has characteristic complications though they all can cause vision loss.  

There are four types of retinal vascular occlusions, also known as RVO, including:

  1. Branch Retinal Vein Occlusion (BRVO)
  2. Central Retinal Vein Occlusion (CRVO)
  3. Branch Retinal Artery Occlusion (BRAO)
  4. Central Retinal Artery Occlusion (CRAO)

All types of retinal vascular occlusions cause sudden and painless loss of vision.  Usually only one eye is affected over the lifetime of a patient. Vision can vary depending upon the exact RVO, but can range from asymptomatic to profound legal blindness.   Treatments exist, but results differ.

There are occlusions affecting veins and disorders affecting arteries of the retina.

Vein Occlusions

Central and branch retinal vein occlusions differ only by the amount of retina which is diseases.  CRVO involve the entire retina. BRVO affects 50% or less of the retina.

Occlusions of the venous system are usually thought to be due to local hardening of the blood vessels and NOT usually associated systemic cardiovascular disease (i.e. heart attack, stroke).  Diabetes and high blood pressure can increase the chance of a vein occlusion occurring, but they do NOT directly cause the veins to plug.

Artery Occlusions

The difference between the central and branch artery occlusion is the same as their venous cousins.  Central affects the entire retina. Branch artery occlusions affect less than 50% of the retina.

Artery occlusions occur when a piece of blood clot, cholesterol, fat or platelets physically block or plug the artery.  These are different types of “emboli” which can occlude the artery. Most “emboli” are cholesterol plaque from the carotid artery.  A tiny piece of cholesterol breaks off into the blood stream, travels to the retina and plugs a blood vessel.

Vision loss from a CRAO is usually profound and permanent.  Smaller branch artery occlusions are associated with blind spots, some elements of the vision may be normal – all depending upon the amount of retina involved.  

Both heart attacks and strokes occur by similar mechanisms.  The presence of a CRAO or BRAO may lead to further assessment of the patient’s chances of developing stroke or heart attack.

 

Though vision loss from artery occlusions tends to be permanent, follow up is necessary to look for signs of neovascularization which can lead to a very painful type of glaucoma.  

 

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