Tag Archives: Lucentis

Byooviz Therapy

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globe anatomy
anatomy of the eye (click on image to enlarge)

What is Byooviz?

            Byooviz is a drug used to treat wet-type macular degeneration, wet-type myopic macular degeneration, and macular edema due to retinal vein occlusion.  It involves repeated injections of medication into the eye to stop abnormal, leaky blood vessels.  Byooviz is an FDA-approved biosimilar drug similar to Lucentis.  Consequently, it costs less than Lucentis (About $1100 per injection of Byooviz compared with $1800 per injection with Lucentis).  Unlike Lucentis, Byooviz is not approved for diabetic retinopathy. 

What is the difference between biosimilar drugs and generic drugs?

While generic drugs are chemically identical with trade-name drugs, biosimilars are not identical to their reference drugs which they attempt to duplicate.  Because biosimilar drugs are different chemically, they may behave differently in terms of effectiveness and side effects.  They may not be as effective as their reference drug and they may have more side effects.  For this reason, biosimilar drugs need to be monitored closely prior to approval by the FDA, as well as after approval by health care providers.  Some adverse effects are not recognized until a drug has been used in thousands (if not more) of patients.  

How effective is Byooviz therapy?      

             Byooviz was shown to be very effective and similar to Lucentis when given every 4wks up to 48 weeks for wet-type macular degeneration.  Currently, therapy often starts with monthly injections until maximal vision is restored. Afterwards, the injections may be given less frequently to maintain stable vision.  It is not known how Byooviz will perform in this setting.

What are the risks of Byooviz therapy? 

            Severe complications are very rare, but risks of Byooviz injection (like Lucentis) include bleeding, infection, retinal detachment, glaucoma, cataract, and loss of vision/loss of the eye. There appears to be a small increased risk (1%) of stroke with these types of medications. The risk of stroke may be related to the older age of patients in which it is used. Pregnancy should be avoided while on Byooviz therapy.              

What do I expect after a Byooviz injection?

Be careful not to rub the eye after the injection because the eye may remain anesthetized for several hours. You may be given eye drops and instructions on how to use them. Physical activity is not limited after the injection. Tylenol or Ibuprofen may be used if there is discomfort, but severe pain should be reported to your doctor without delay. It is normal to experience a red area on the white of the eye, which disappears in one to two weeks. If you have any questions or concerns, please call the office.

What does Dr Pautler think about Byooviz?

It is the opinion of the author that there are several concerns about Byooviz. First, the safety and effectiveness of Byooviz need to be determined on a large scale with many more patients than studied for FDA approval. This may take several years of use. Until then, I prefer Lucentis as it has a proven track record. Secondly, the cost of Byooviz appears too high. The cost of Byooviz is less than Lucentis, but not by much. A lower cost is more appropriate given the unknown risks and long-term effectiveness of Byooviz. If I have a patient whose insurance covers Lucentis, that is my choice over Byooviz at this time. If a patient has a Medicare Advantage insurance plan, I may be forced to use Byooviz.

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

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Susvimo: Lucentis Port Delivery

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anatomy of the eye (click on image to enlarge)

What is Lucentis therapy?

            Lucentis therapy is a treatment for wet-type macular degeneration.  It usually involves repeated injections of medication into the eye to stop abnormal, leaky blood vessels. It is now also available through port delivery (called Susvimo).  After a tiny reservoir is implanted in the eye at surgery, a painless injection to fill the port is performed every 6 months.     

How effective is Lucentis therapy?      

             Lucentis was proven in extensive studies to be very effective. In wet-type macular degeneration, a large study showed that monthly injections of Lucentis over a two-year period offered a 90% chance of stable or improved vision. Similar benefits are seen in other retinal conditions as well. Traditionally, therapy often starts with monthly injections until maximal vision is restored. Afterwards, the injections may be given less frequently to maintain stable vision. The Lucentis port delivery appears to be as effective as Lucentis monthly injections, but with fewer injections.    

What are the risks of Lucentis therapy? 

            Severe complications are very rare, but risks of Lucentis injection include bleeding, infection, retinal detachment, glaucoma, cataract, and loss of vision. There appears to be a small increased risk (1%) of stroke with Lucentis. The risk of stroke may be related to the older age of patients in which it is used. Pregnancy should be avoided while on Lucentis therapy. 

            The port delivery method (Susvimo) is associated with more adverse events (19%) compared with monthly Lucentis injections (6%). Among eyes with the implanted port, 5-10% had bleeding inside the eye causing floaters and blurred vision. The blood cleared over several weeks to months. In 5.4% of eyes with the implanted port, the conjunctiva (skin-like layer that covers the eye) does not remain intact overlying the implant and additional surgery is often needed.  In 1-2% of eyes with an implanted port, infection may occur.  This is a very serious event that requires surgery and may result in permanent loss of vision/loss of the eye. In 1-3% of eyes with an implanted port, a retinal detachment required additional surgery and sometimes resulted in loss of vision.  Non-infectious inflammation occurs in about 20% of implanted eyes; it usually responds to eye drops. The benefits of fewer injections with the port delivery method must be weighed against the risks involved with the port. It is the opinion of the author that the risks of the Susvimo port delivery may outweigh the benefits at this time for most patients. Newer medications (Vabysmo) are available that appear to last longer than other treatments such as Lucentis injections. Therefore, Susvimo port delivery may be unnecessary.

What do I expect after a Lucentis injection?

Be careful not to rub the eye after the injection because the eye may remain anesthetized for several hours. You may be given eye drops and instructions on how to use them. Physical activity is not limited after the injection. Tylenol or Ibuprofen may be used if there is discomfort, but severe pain should be reported to your doctor without delay. It is normal to experience a red area on the white of the eye, which disappears in one to two weeks. If you have any questions or concerns, please call the office. 

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

Copyright ©2022 Designs Unlimited of Florida.  All Rights Reserved.

Myopic Macular Degeneration

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myopic-macular-degeneration
Anatomy of the Eye (click on image to enlarge)

What is myopic macular degeneration?

Myopic macular degeneration (MMD) is a degeneration of the center of the retina seen in some people who are myopic (near-sighted). MMD is not the same as age-related macular degeneration. The macula is the area of the retina in the back of the eye that is responsible for seeing details in the central vision.  The retina is a thin layer of delicate nerve tissue that lines the inside wall of the eye like the film in a camera.  In the eye, light is focused onto the retina, which “takes the picture” and sends the image to the brain.  Although macular degeneration affects the central vision, it does not affect peripheral vision— the ability to see objects off to the side when looking straight ahead.  This means that macular degeneration alone does not result in total blindness.  

What causes myopic macular degeneration?

Changes in the shape of the near-sighted eye cause myopic macular degeneration.  The normal shape of the eye is round like a ball. As an eye becomes myopic, the eye elongates and looks more like the shape of an egg. The elongation of the eye means that the retina becomes stretched and thin. This causes macular degeneration in some eyes over time. The higher the amount near-sightedness (the thicker your glasses), the greater the chances of myopic macular degeneration. Two forms of MMD are “dry” and “wet”.  However, the wet type may become “dry” and the dry type may become “wet” over  time:

  • Dry macular degeneration is the most common type and involves the disintegration of the light-sensitive tissues in the macula.  Loss of vision is usually gradual in dry macular degeneration.  
  • Wet macular degeneration occurs in a small group of eyes with MMD.  It occurs when abnormal blood vessels grow under the macula and cause fluid leakage, bleeding, and scarring of the macula.  Vision loss may be rapid and severe. An important, but under-recognized form of wet MMD is dome-shaped maculopathy.

What are the symptoms of myopic macular degeneration?

Macular degeneration may cause no symptoms in its early stages.  Over time, symptoms may include the need for more light while reading and blurring of central vision, often with distortion or a blind spot. Although macular degeneration is usually present in both eyes, it may cause visual symptoms in only one eye. Rarely, severe loss of vision occurs in both eyes, and render a person legally blind. However, total blindness is extremely rare in myopic macular degeneration.

How is myopic macular degeneration diagnosed?

A dilated eye examination can detect myopic macular degeneration before visual loss occurs.  The hallmark of myopic macular degeneration is a thinning of the macula due to stretching of the retina and the underlying blood vessel layer that gives nutrition to the retina.  After the diagnosis is made, a fluorescein angiogram is often helpful.  In this procedure the ophthalmologist injects an organic dye into the vein of the arm.  Photographs of the retina are taken to reveal the presence and location of the leaking blood vessels marked by the organic dye.

How is dry myopic macular degeneration treated?

No specific treatment is required for eyes with MMD and no symptoms. However, it may be helpful to avoid eye rubbing. If the eyes feel tired at the end of the day, warm compresses are safer than rubbing the eyes. A Bruder mask may be purchased at the drug store or online. It may be heated in the microwave for 10 seconds and placed on the eyes after testing the temperature. It provides warm moist heat that soothes the eyes. 

How is wet myopic macular degeneration treated?

Medication injections (Avastin or Lucentis) performed in the office often help preserve vision in wet MMD.  Treatment rarely returns vision to normal, but may limit the amount of vision loss from blood vessel growth and leakage. Frequent office visits and photographs are needed to monitor for activity and determine the need for treatment. The Amsler grid test is used at home to help monitor the vision. If the grid test shows new or progressive distortion in the vision, notify the eye doctor within a few days.

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

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The risk of stroke with treatment of Age-Related Macular Degeneration

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The mainstay of treatment of wet-type age-related macular degeneration (AMD) requires the intraocular injection of medication (e.g. Avastin, Lucentis, Eylea, Beovu, and Vabysmo) to prevent loss of vision. Although effective, this treatment entails some degree of risk. For example, infection may occur at a rate of about one in one thousand to one in five thousand injections. Moreover, there may be a low increased risk of stroke.

Although some studies do not show increase risk (Campbell), other large studies have demonstrated an increased risk of stroke. In one study the increased risk of stroke appeared to be 1 in 127 patients within one year after starting treatment for AMD (Schlenker). These studies were unable to prove that the medication itself was responsible for the increased risk of stroke. For example, it may be that people with new-onset wet AMD are at a higher risk of stroke than others. In 2019 a population-based study demonstrated no increased risk of stroke and heart attack related to AMD treatment (see reference). Additional research in ongoing.

Given this information what are the options? Certainly, a patient may decide not to treat macular degeneration and risk loss of vision in an effort to decrease the risk of stroke. Another option may be to minimize the frequency of injections. That is, if the macular degeneration remains stable after several monthly injections, consider extending the time interval between injections. In this manner there is less exposure to the drug. Furthermore, if the wet-AMD appears to have reached end-stage with significant loss of vision, the injections might be stopped altogether. If done carefully, one may reduce the risk of a sudden recurrence of wet-AMD with further loss of vision while off treatment.

The type of medication used for injection has not been proven to make a difference in the risk of stroke. Although Martin et al found a slight increase in stroke risk with Avastin compared with Lucentis, these findings were not supported by Chakravarthy and Schlenker. More research is needed to better define risk of stroke and how we may minimize the risk. A recent meta-analysis of current data as of 2022 (Reibaldi) supports Lucentis over the other agents as being safer from a systemic risk of heart attack and stroke.  Please refer to my blog on medication choices for treating retinal problems.

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

References:

Ophthalmology 2012 119:1604-1608 Campbell

AJO 2015 160:569-580 Schlenker

Ophthalmology 2012 119:1388-1398 Martin

Ophthalmology 2012 119:1399-1411 Chakravarthy

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Retinal Vein Occlusion

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What is a retinal vein occlusion (RVO)?

Retinal vein occlusion means blockage of a vein in the retina.  The retina in your eye is like the film inside a camera.  The retina “takes the picture” of objects you look at and sends the message to the brain.  The retina is a living tissue, which requires blood supplied by tiny vessels.  Retinal veins are blood vessels that drain blood out of the retina. An abnormal blood clot in a retinal vein causes a blockage (occlusion) of the blood flowing out of the retina.  Depending on the location of the occlusion, vein occlusions are divided into branch retinal vein occlusion and central retinal vein occlusion.

retinal vein occlusion
anatomy of the eye (click on image to enlarge)

Who is at risk for a retinal vein occlusion?

Retinal vein occlusions occur in 1-2% of people over 40 years of age. Retinal vein occlusions are more common in people who are overweight, use tobacco or estrogen, or have hardening of the arteries, diabetes, high blood pressure, sleep apnea, glaucoma, or blood disorders.

What are the symptoms of a retinal vein occlusion?

Blurring of vision may occur if excess fluid (edema) leaks from the veins into the center of the retina.  Floaters can look like tiny dots or cobwebs moving about in your vision.  They may be due to bleeding from the retina into the central gel of the eye.  Pain is rare and may be due to high pressure in the eye (neovascular glaucoma).

What treatment is available?

There is no cure, but treatment may improve vision or keep the vision from worsening.  Your doctor may allow time for the vein to heal.  Sometimes eye drops or pills may be prescribed.  Medicine injections (Avastin, Lucentis, Eylea, steroids) may help recover vision and may be applied without pain in most cases. Injections may be required for the long-term; about half of eyes with central retinal vein occlusion require injections for at least three years. Injections for retinal vein occlusion are safe in regard to risks of problems outside the eye. However, there appears to be a low risk of stroke (intracranial hemorrhage) of <4/1000 every year of treatment.

Laser may stabilize or improve the vision.  The vision may not return to normal following treatment as there may be some permanent damage to the retina from the occlusion.  In some cases when treatment cannot improve the vision, laser is used to prevent severe pain and complete blindness.

Your doctor is going to order appropriate tests and recommend the best course of action to take at this time.  The retinal vein occlusion will not be worsened by your daily activities or by using your eyes. You may monitor the vision with the Amsler grid test.  It is important to be seen by your primary care doctor to treat risk factors of hardening of the arteries to prevent stroke and heart attack.

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

recent BRVO
blood spots and white exudates in retina from recent brach retinal vein occlusion (click on image to enlarge)
healing BRVO
Fewer blood spots as vein occlusion heals with Avastin (click on image to enlarge)
CRVO
Recent-onset central retinal vein occlusion of left eye

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Painless eye injections

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painless eye injections
Eye anatomy

Why are eye injections given?

Increasingly, medicines are injected into the eye to treat a variety of conditions including macular degeneration, diabetic retinopathy, and retinal vein occlusion. Many different medications are injected including Lucentis, Avastin, Eylea, Beovu, Vabysmo, Syfovre, Izervay, and steroids. Especially, because these medicines may require repeated injections over time, it is essential these injections cause no pain. Therefore, we go out of our way to provide painless eye injections.

What choices of anesthesia is available?

There are currently many different ways to anesthetize the eye before an injection. Most doctors use an anesthetic eye drop. Additional local anesthesia is usually given with either a pledget, a gel, or a painless injection. A pledget is a small piece of cotton or other absorbent material that is soaked in anesthetic and placed inside the lower lid to numb the eye in preparation of an injection. Rarely, an anesthetic injection is needed. While an anesthetic injection sounds worse, it causes no pain (due to the anesthetic drops) and works better in some patients to avoid pain with the intraocular injection of medicine.

What needles are used for injecting medicine?

Fine needles are used for injection to minimize discomfort. The standard needle size for injections into the eye is 30 gauge. However, most medications may be injected with much finer 33 gauge needles. There are some medications, such as Syfovre, that require larger bore needles due to viscosity.

What are other causes of pain with eye injection?

In rare instances pain may occur due to an increase in the eye pressure. When medicine is injected into the eye it takes up space. Because the eyeball does not enlarge like a balloon, the pressure inside the eye increases. Usually, this increase in pressure is well tolerated. However, in some patients the increase in pressure may cause pain. In this situation the doctor may elect to remove a small amount of fluid from the eye before injecting the medicine in order to avoid the pressure increase and the associated pain.

Measures can be taken to avoid pain with most eye injections. Another issue is pain after an eye injection. Please see link for more information.

By Scott E. Pautler, MD

For a telemedicine consultation with Dr Pautler, please send email request to spautler@rvaf.com. We accept Medicare and most insurances in Florida. Please include contact information (including phone number) in the email. We are unable to provide consultation for those living outside the state of Florida with the exception of limited one-time consultations with residents of the following states: Alabama, Arkansas, Connecticut, Georgia, Minnesota, and Washington.

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