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Beovu, a prescription medication used to treat neovascular macular degeneration, has recently been linked to severe vision loss and blindness caused by occlusive retinal vasculitis, retinal vascular occlusion, and intraocular inflammation.
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What is Beovu?

Manufactured and marketed by Novartis, Beovu injection is a human vascular endothelial growth factor (VEGF) inhibitor used to treat wet AMD.

The prescription drug is administered by intravitreal injection, and doctors prescribe Beovu at 6 mg (0.05 mL of 120 mg/mL solution) monthly (approximately every 25-31 days) for the first 3 doses, followed by 1 dose of 6 mg (0.05 mL) every 8-12 weeks. The Beovu injection was FDA approved in October 2019.

What's the Problem?

Recent Beovu lawsuits allege that Novartis failed to adequately warn patients that use of Beovu could result in vision loss, blindness, and other serious complications. Former Beovu users have been diagnosed with vision related problems including retinal vasculitis, retinal artery occlusion, inflammation and more.

The American Society of Retina Specialists (ASRS) [1] in February 2020 issued a warning which stated that at least 25 cases of retinal inflammation (vasculitis) had been reported in patients who had received Beovu injections.

Of these, 21 were also diagnosed with occlusive retinal vasculitis (retinal occlusion), an inflammatory eye condition that can lead to blindness.

See Other Novartis Cases We've Taken: Valturna Lawsuit

Severe Vision Loss

Beovu Side Effects

Patients taking Beovu may experience the following severe side effects:

  • Vision problems
  • Severe vision loss
  • Peripheral vision loss
  • Chronic eye disorder
  • Blindness
  • Retinal vasculitis
  • Retinal vein occlusion
  • Retinal artery occlusion
  • Intraocular inflammation

Rare adverse events of Beovu may include:

  • Blurred vision
  • Cataracts
  • Bleeding in the eye
  • Eye pain
  • Eye "floaters"

What is Macular Degeneration?

Age-related macular degeneration, or "Wet AMD," occurs when abnormal blood vessels grow into the macula. These leak blood or fluid, which leads to scarring of the macula and rapid loss of central vision. Wet macular degeneration can develop very suddenly, but it can be treated if caught quickly.

Macular disease affects people in different ways:

  • Gaps or dark spots (like a smudge on glasses) may appear in your vision, especially first thing in the morning. Objects in front of you might change shape, size or color or seem to move or disappear.
  • Colors can fade.
  • You may find bright light glaring and uncomfortable or find it difficult to adapt when moving from dark to light environments.
  • Words might disappear when you are reading.
  • Straight lines such as door frames and lampposts may appear distorted or bent.

Treatment for Abnormal Blood Vessels

A variety of treatments are available to treat wet AMD. Successful Beovu treatment may not restore normal vision; however, it will improve sight and prevent central vision loss from worsening. While laser procedures can destroy the abnormal blood vessels, they also damage the neighboring retinal artery.

Prescription drugs including Eylea, Lucentis, and Macugen can help treat wet AMD by preventing the growth of leaky blood vessels in your eye. Lucentis is administered once per month, although some patients may need treatment only once every 3 months.

Macugen is given every 6 weeks. Eylea is given once every 2 months after 3 once-monthly injections.

How Common is Wet AMD?

Wet AMD is the leading cause of vision loss in the United States and in many other countries. In fact, it impacts over 10 million Americans. That number represents more than those with glaucoma and cataracts combined.

How is it Diagnosed?

Tests to diagnose macular degeneration include an eye examination and a self-test that can be done at home. There are also several imaging tests that an ophthalmologist can use to detect the abnormal blood vessel development (neovascularization) and bleeding that occurs in the eyes of those with wet AMD.

However, it's important to note that wet AMD is not the only cause of these symptoms. Therefore, other conditions must be ruled out before a person can be positively diagnosed with wet AMD.

The Amsler grid (sometimes referred to as the Amsler chart) is the most common test that is used at home to screen for wet age-related macular degeneration.

The chart displays horizontal and vertical lines, and is used to evaluate and monitor changes in a person's central visual field. The grid can be used to perform ongoing self-eye screenings at home.

When using the Amsler chart, simply check your eyes to see whether the lines look straight or appear wavy or distorted in any way. Other signs to check for include whether areas of the chart appear missing, which would indicate a visual field defect.

Beovu News: Whistleblower Lawsuit Alleges Novartis Published Incorrect Beovu Safety Data

Novartis has been accused of failing to disclose accurate Beovu safety data in a recent whistleblower lawsuit filed by a former employee.

In the days leading up to Beovu's approval by the Food and Drug Administration, one Novartis employee was reportedly urging her employer to correct inaccurate Beovu safety data. Instead of correcting their error, Novartis fired the employee for speaking up, according to the lawsuit.

The plaintiff, a former Novartis worldwide brand medical director, alleges that an external safety review committee falsely indicated that the stroke and heart attack risk for a competitor product was double the risks seen with Beovu. This information was reportedly inaccurate, with the plaintiff describing the risks from the 2 drugs to be similar.

Additionally, Novartis published a confirmed safety signal that allegedly included a “material omission” which misrepresented ocular inflammation rates. This data said that the rates of ocular inflammation seen in their product exceeded those seen in a competitor product, the complaint alleges.

The plaintiff says that she “reasonably believed that Novartis’ failure to disclose material information violated consumer safety laws, was fraudulent or criminal, and/or violated public policy concerning public health, safety, and welfare.”

“Novartis retaliated against [her] by conducting a sham investigation and ultimately terminating her employment,” the Beovu whistleblower lawsuit contends.

Novartis’ investigation reportedly centered around a series of events linked to the plaintiff’s visa requirements, as she had previously worked in Canada. These allegations were allegedly used to silence the plaintiff and fire her.

Novartis said that any inaccurate Beovu safety data was corrected between February and September 2018, and disclosed to clinical investigators and steering committees. Since these corrections, Beovu safety data presentations included accurate information. The company says that, even after making the corrections, the overall findings of their clinical trials were unchanged.

The company maintains that the whistleblower lawsuit from their former employee “is without merit” and will be vigorously defended by their lawyers.

Beovu Blindness Investigation

A study published in the July 2020 edition of the Journal of VitreoRetinal Diseases [2] found that retinal vasculitis had been identified in multiple patients who had recently undergone injections with Beovu.

"Although a few eyes in this series were asymptomatic or minimally symptomatic, some eyes had significant vision loss," the researchers said."A careful examination for signs of active inflammation prior to [Beovu (brolucizumab)] injection is recommended."

The authors concluded by stating that once vasculopathy is suspected, angiographic imaging may help define the spectrum of involvement; however, optimal treatment strategies remain unknown.

"Stop Beovu Injections Now": Editorial Warning

In May 2020, an editorial piece published in the American Journal of Ophthalmology stated that use of Beovu injections should be discontinued until the cause of eye inflammation associated with the medication is identified.

"As this process plays out, it is our view that intravitreal injections of [Beovu (brolucizumab)] should stop," the author said. "[Beovu (brolucizumab)] is not the only drug that can be used for the treatment of [exudative age-related macular degeneration (eAMD)]. In the face of the known risk, its use is unwarranted."

EMA Approves Beovu Label Change to Include Retinal Vasculitis, Vascular Occlusion Warning

Novartis in September 2020 announced that the Committee for Medicinal Products for Human Use (CHMP) had approved an update to the Beovu Summary of Product Characteristics to include warnings about retinal vasculitis and retinal vascular occlusion [3].

"Typically, these events occurred in the presence of intraocular inflammation," Novartis said in the announcement. "This approval follows Novartis’ announcement that it would pursue worldwide label updates after a review and further characterization of post-marketing safety events reported to Novartis."

Woman Diagnosed With Vasculitis After 2 Beovu Injections: JAMA Study

In August 2020, a study published in JAMA Ophthalmology [4] described the case of a 77-year-old woman who suffered from acute visual acuity loss in her right eye following her second administration of Beovu for neovascular age-related macular degeneration.

The woman had previously been treated with both Avastin (generic: bevacizumab) and Eylea (generic: aflibercept) since her initial diagnosis in 2018, but had never had any problems with either medication. After her first injection with Beovu, the woman immediately noted blurry vision, which she believed would be temporary. However, she returned to the office 3 weeks later with a visual acuity of 20/200 OU.

Committee Reviews Safety Risks of Beovu

A Novartis safety review committee in July 2020 identified a rate of 4.6% intraocular inflammation (IOI) of all types associated with Beovu injections. Of these, there was a subgroup of 2.1% of patients who developed occlusive vasculitis, according to Paul Hahn, MD, PhD, who moderated the committee. "If you have a patient who presents to your office having occlusive vasculitis following recent Beovu, that patient has a 1 in 5 risk of at least six-line vision loss,” Hahn said.

What is Retinal Vascular Occlusion?

Vasculitis of the eye is caused by inflammation of blood vessels in the retina (retinal vasculitis). Retinal vasculitis ranges in severity from mild to severe. Damage to the blood vessels of the optic nerve can cause partial or complete blindness.

Retinal Vasculitis Symptoms

  • Decrease of visual acuity (blurry vision)
  • Decreased vision
  • Visual distortions
  • Visual floaters
  • Scotomas (dark spot in vision)
  • Decreased ability to distinguish colors
  • Metamorphopsia (distortion of images such as linear images)

Beovu Warning: Retinal Vasculitis Can Lead to Blindness

A February 2020 article published in Vantage titled “Safety Scare Knocks Novartis” [5] describes essential information about emerging safety issues with Beovu:

"Most worrying was the medical body’s alert about several cases of a dangerous form of eye inflammation called vasculitis; although this was seen in Beovu’s clinical programme, these occurrences appear to confirm that this is a real issue for the product," said Amy Brown, author of the report. "Retinal vasculitis can lead to blindness and although only 14 cases were reported to the ASRS, 11 were classified as occlusive retinal vasculitis. This happens when the smaller retinal vessels become blocked, and is of even greater concern."

Has Beovu Been Recalled?

To date, Beovu has not been recalled and continues to be prescribed to thousands of unsuspecting patients around the country.

While the U.S. Food and Drug Administration approved Novartis’ label change, it did not issue a safety communication to the public or announce any regulatory actions.

Another drug involved in vision loss lawsuits is FDA approved Elmiron. According to Elmiron lawsuits, Janssen Pharmaceuticals Inc. failed to warn that the drug could cause a rare disorder called retinal pigmentary maculopathy.

Like retinal vasculitis, retinal pigmentary maculopathy can cause permanent vision loss.

FDA hasn’t announced a recall for Elmiron or issued a safety announcement. Janssen added a warning for retinal pigmentary maculopathy in June 2020.

What Compensation Could I Be Awarded?

If you developed retinal vasculitis, retinal artery occlusion, intraocular inflammation, or other vision problems after receiving Beovu injections, our law firm will be seeking the following types of damages for you:

  • Past and future medical expenses to treat your injuries
  • Past and future pain and suffering that results from your injuries
  • Lost wages
  • Other economic losses experienced because of your injuries
  • Punitive damages, if appropriate

Has a Class Action Been Filed?

To date, there have been no large class action Beovu lawsuits.

This is because Beovu is a new drug and litigation like this takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented.

Large groups of settlements do not generally occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk. The first step in this process is usually having large groups of cases combined in federal court for discovery purposes. This process is known as Multi-District Litigation (MDL).

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Other Resources: Dangerous Drugs Lawsuits

Get a Free Beovu Lawsuit Evaluation With Our Lawyers

The Pharmaceutical Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Beovu Lawsuits. We are handling individual litigation nationwide and currently accepting new Beovu lawsuits in all 50 states.

If you or a loved one suffered vision related side effects from Beovu, you should contact our Beovu attorneys immediately. You may be entitled to financial compensation by filing a Beovu lawsuit and we can help.

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