“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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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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Macular Degeneration

Signs and Symptoms of Macular Degeneration

is the deterioration of the central portion of the retinathe macula, which is the area of the retina that controls visual acuity and color perception. Macular degeneration usually occurs in people over the age of 55 and is more common in people of northern European ancestry.

Symptoms of Macular Degeneration

The most common symptoms of macular degeneration are blurry vision, blind spots, and distortion.  

New distortion should always be examined and can be monitored at home with the use of the Amsler grid.

Blurriness, blind spots, and distortions are also common symptoms in the following eye diseases:

  • macular edema (swelling) from many causes
  • epiretinal membrane
  • macular hole
  • diabetic retinopathy

Distortion is a common symptom of a disease of the macula and is does not signify a particular disease (i.e. get examined).

The Macula

The macula provides our central “20/20” vision.  As you are reading this article, your eyes are moving to keep the text focused on your macula.  When you are staring at an object, you are focusing the object on your macula.

Macular degeneration can be wet or dry and both types progressively affect the central vision causing blurriness, blind spots, and distortions. However, the wet form causes more serious vision loss.

Retinal Degeneration

For reasons yet to be discovered, the macula degenerates with age.  There are probably environmental risk factors, such as smoking, which increases the chances of developing macular degeneration.

The vast majority, 90% of cases, are the dry variety, which causes very slow, yet progressive blurry vision.  Wet ARMD causes the development of abnormal blood vessels within the layers of the macula.  These blood vessels cause destruction of the normal retinal tissue and can leak fluid and bleed.

Regardless of the type of macular degeneration, the initial symptoms are the sameblurriness, blind spots, and distortion.  However, wet macular degeneration can destroy vision rapidlyin days or weeks.  

What Can You Do?

If you have symptoms such as persistent blurry vision, blind spots, and/or distortion, make sure you get a complete dilated eye examination. 

While there are many causes of blurry and distorted vision other than macular degeneration, you want to make sure that you get an early diagnosis so whatever eye condition is causing your visual symptoms, the proper treatment can be initiated early in the process.  

Early diagnosis and treatment of eye diseases may prevent or limit permanent vision loss.


Macular Degeneration

Do Drusen Diagonse Macular Degeneration?

The simply answer is, no, not all patients with drusen have macular degeneration. Drusen can be associated with macular degeneration, but are not diagnostic of the disease.

In other words, a person can have drusen AND macular degeneration which means that the two conditions are associated because they can occur together, but the presence of drusen by themselves without other signs or symptoms does not mean macular degeneration is going to occur or is in the process of occurring.

What are Drusen?

Drusen are spots (lesions) that form in the layers of the retina. There are two types and can be “hard” or “soft.” based upon appearance.   The presence of a few small drusen is normal with advancing age.

Drusen can be found anywhere in the retina.  When they are located outside the macula, they are usually of no consequence and are not related to any disease, especially macular degeneration.  I am only concerned when they are located within the macula.

Unfortunately, most non-retina doctors do not mention that drusen away from the macula are of little consequence and can simply be a family trait.

When Should Macular Degeneration be Diagnosed?

Let’s take the scenario of a patient having only hard drusen and no other signs of macular degeneration such as pigment changes, fluid, or blood.

Is there vision loss?  If there is vision loss, the next thing I do is determine if there are reasons for it other than macular degeneration, such as cataracts.

When a patient has no vision loss or a loss of vision that is explained by something such as cataracts, I do not necessarily diagnose macular degeneration.

I know that many doctors DO diagnose macular degeneration every time they see drusen, and in my opinion, this is not correct or fair. Unnecessarily pronouncing this diagnosis to patients causes many people worry, anguish, and stress as they wait to go blind from a disease they do not have.

Best Test for Macular Degeneration Diagnosis

If there is any question about the diagnosis of macular degeneration, have your doctor order a fluorescein angiogram.

A fluorescein angiogram (FA) is the best test for a definitive diagnosis of  macular degeneration (ARMD).  The test is performed by a retinal specialist and each eye is injected with a dye (not iodine based) called fluorescein.  As the fluorescein dye travels through the retinas, pictures are taken which help the retinal specialist diagnose or rule out macular degeneration.

In cases of a positive diagnosis for macular degeneration, a fluorescein angiogram will also distinguish between wet ARMD and dry ARMD, so that the proper treatments can be undertaken as soon as possible.

All the best,

Randall Wong, M.D.
Retina Specialist
Fairfax, Virginia 22030

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