Beovu Update: No Recall Yet, But 3 Clinical Trials Have Been Terminated

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The intravitreal (eyeball) injection drug Beovu hasn’t even been on the market for two years, but its history has been eventful.

This medication was meant to help patients with an eye problem known as wet age-related macular degeneration (AMD)—specifically, to offer an option that would allow for less frequent treatments than existing drugs on the market. Shortly after it started clinical use, though, reports emerged that some Beovu patients had suffered serious adverse effects beyond what was on the warning label (and distinct from the risks associated with other drugs used to treat wet AMD).

For the patients who suffered the worst Beovu eye injuries, the treatment that was meant to prevent the gradual loss of vision associated with macular degeneration instead caused severe and rapid vision loss.

What Is Happening With Beovu?

Novartis announced that it was terminating three of these clinical trials early “in the interest of patient safety.”
 

While the medication hasn’t been recalled (yet), it has already been the subject of a safety alert issued by the American Society of Retina Specialists, a warning label update approved by the U.S. Food and Drug Administration, and numerous lawsuits. Most recently, at the end of May 2021, Novartis announced the early termination of three clinical trials due to concerns related to “patient safety.”

Beovu Linked to Retinal Damage Within Months of FDA Approval

Less than six months after Beovu received FDA approval in October 2019, the first warnings of serious eye problems that can lead to vision loss and blindness emerged. It wasn’t the FDA that issued these warnings, but instead the American Society of Retina Specialists.

The alert, which was issued to members of the professional society on February 23, 2020, reported 14 cases of a serious adverse event, retinal vasculitis, that had been observed in patients treated with the eye injection Beovu. Retinal vasculitis wasn’t listed on the warning label for Beovu at the time, and the condition also isn’t a side effect that had so far been reported among other drugs in the same class (anti-VEGF) as Beovu, according to Fierce Pharma’s coverage of the situation.

Novartis, the manufacturer of Beovu, began conducting a safety review following these reports. The company’s early media advisories reported that “the rate of the reported post-marketing events remains consistent with or below the approved prescribing information.” Further, Novartis stated in March 2020 that “currently, there is no validated new or changed safety signal.” By April, though, that perception had changed. “There is a confirmed safety signal of rare adverse events,” Novartis reported. By June 9, 2020, the FDA had approved a revised warning label for Beovu that now included retinal vasculitis and retinal vascular occlusion.

What is Retinal Vasculitis?

Retinal vasculitis refers to inflammation of the blood vessels that provide blood supply to the retina, a thin light-sensitive lining of the eye that is necessary for sight. When retinal vasculitis occurs, it can leave the patient with severe vision loss.

What Is Retinal Artery Occlusion?

Retinal artery occlusion happens when the central retinal artery or its branches becomes blocked, such as by a blood clot. Although retinal artery occlusion does not hurt, it can cause sudden and severe vision loss.

Beovu Clinical Trials Terminated

Although Beovu was already approved for the U.S. market, Novartis had continued to run clinical trials investigating the drug’s use at different dosages and administration intervals. At the end of May 2021, Novartis announced that it was terminating three of these clinical trials early “in the interest of patient safety.”

Holding the Manufacturer Accountable for Vision Loss Caused by Beovu

The vision loss that can result from serious conditions like retinal vasculitis and retinal artery occlusion can be extensive and, often, permanent. It may come as no surprise, then, that patients who suffered life-altering losses of vision from the drug—due to adverse effects that weren’t even mentioned on the warning label—have chosen to hold Novartis accountable. They are doing this by filing Bevou eye injury lawsuits.

Lawsuits filed against Novartis can help Beovu patients recover compensation for the additional medical care and rehabilitative therapies they needed due to their vision loss, as well as losses in earning capacity, other costs of living with low vision, and pain and suffering. The first Beovu lawsuits were filed in early 2021, and law firms handling Beovu claims are continuing to accept new cases at this time. Beovu cases, like other pharmaceutical injury claims, are usually handled on a no-win, no-fee basis, so patients and their families won’t have to pay anything upfront for legal representation.

If you think you may have the grounds for a Beovu eye injury lawsuit, you should take the following steps right away:

    1. If you haven’t already done so, see an ophthalmologist about the vision changes you have noticed.
    2. Speak to a Beovu eye injury law firm to launch an initial investigation of your claim at no cost.

From the time Beovu was approved to the time the warnings of retinal vasculitis and retinal artery occlusion first emerged, tens of thousands of doses were administered to patients. More patients continued to receive Beovu injections before the warning labels were updated. If you were given Beovu to treat wet AMD and your eyesight got unexpectedly worse, you may have a case—but it’s important to act fast, before you lose the opportunity to file a lawsuit.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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