FDA Approves Xipere for Macular Edema Associated With Uveitis
Key takeaways:
Xipere (triamcinolone acetonide) is now FDA-approved to treat macular edema associated with uveitis.
Xipere is given as a suprachoroidal injection into the eye. This new method is thought to be a more targeted way to deliver the medication to the back of the eye.
Xipere is expected to be available in the first quarter of 2022.
Last month, the FDA approved Xipere (triamcinolone acetonide) to treat macular edema associated with uveitis. Triamcinolone injections have been used to treat eye conditions for decades. But Xipere uses a new way to deliver the medication that may have some potential advantages over current methods.
Xipere will be available as a single-dose vial. It also comes with a special syringe and needle to help the medication reach the back of your eye. This is thought to concentrate more of the medication in targeted areas while lowering the risk of side effects.
Here we’ll cover what you should know about Xipere’s approval, how it works, and when it’s expected to be available.
What is Xipere?
Xipere (triamcinolone acetonide) is an injectable steroid medication. It’s FDA-approved to treat macular edema associated with uveitis.
Uveitis is a type of eye inflammation. Symptoms can range from eye pain to vision loss. Macular edema — an accumulation of fluid in the retina — is a common complication of uveitis. This can cause vision problems and ultimately, vision loss.
Xipere is also the first medication that’s injected into the suprachoroidal space of the eye. Similar medications are sometimes given as an intravitreal injection. This means they’re injected into the gel-like liquid between the lens and retina of your eye. But this type of injection has been associated with side effects like elevated eye pressure and cataracts.
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Suprachoroidal injections are thought to help more of the medication reach the retina and other areas of the eye that are most affected by the condition. This method is thought to be more targeted, which might lower the risk of cataracts, glaucoma, and other complications.
How does Xipere work?
Xipere contains triamcinolone acetonide — a corticosteroid. Corticosteroids work by lowering inflammation and swelling in your body. When injected into your eye, it can lower the swelling in your retina caused by macular edema. This can help improve blurry vision from fluid buildup.
In clinical trials, Xipere was shown to significantly improve a person’s best corrected visual acuity (BCVA) from their baseline at 6 months. BCVA is the best possible vision after correction (e.g., glasses). This is measured by how many letters are read correctly on an eye chart.
Almost 50% of people who received Xipere gained a 15-letter or more improvement at 6 months. This is considered to be clinically meaningful. Sixteen percent of people in the placebo group showed similar improvement.
Xipere is the first medication of this type to show effectiveness based on improvement in BCVA.
How is Xipere dosed?
Xipere will be available as a single-dose vial that contains triamcinolone acetonide. It will also come with a special syringe and needle for suprachoroidal injection. The recommended dose is 4 mg of triamcinolone acetonide injected into the suprachoroidal space.
Xipere isn’t something you can inject yourself at home. So, you’ll need to have it administered by a healthcare professional. Depending on your response to treatment and underlying factors, your provider will determine the need for repeat injections.
What are the potential side effects of Xipere?
As with all medications, you may experience some side effects with Xipere. Some side effects may be acute, meaning that they occur quickly after the injection. Others may be non-acute. This means that they occur days to weeks after the injection and can take time to resolve.
The most common side effects reported during clinical trials included:
Non-acute elevated eye pressure
Non-acute eye pain
Cataracts
Acute elevated eye pressure
Headache
Vitreous detachment is another side effect that was reported during clinical trials. This is when the gel-like liquid in your eye detaches from the retina. Symptoms include “floaters” (seeing squiggly lines or dark spots) and flashes of light in your peripheral vision. Let your provider know if this happens.
A few of these side effects happened at a similar frequency in people receiving Xipere compared to those who didn’t (called the placebo group). This included non-acute elevated eye pressure and cataracts.
Contact your eye specialist immediately if you experience vision changes (e.g., blurred vision, light sensitivity), eye redness, or eye pain. This could be a sign of something more serious.
Are there any risks?
Corticosteroids like Xipere can suppress your immune system. This can raise your risk of infections in your eye caused by viruses, bacteria, or fungi. For this reason, Xipere shouldn’t be used if you have an active or suspected eye infection.
Let your healthcare provider know if you have a history of herpes infections in your eye (called ocular herpes). It’s possible that Xipere could reactivate an ocular herpes infection.
Xipere can potentially cause allergic or hypersensitivity reactions in some people. Tell your provider about all of your allergies. This is to make sure you’re not allergic to the medication or any of its ingredients. If you are, your provider may advise against receiving Xipere.
Corticosteroids can also affect stress hormones in your body, especially if used for longer periods of time. There’s a low risk that this injection can result in higher blood sugar levels, stress hormone issues, and other related conditions. Your healthcare provider should be monitoring you in case this happens.
When will Xipere be available?
Xipere is expected to be available in the first quarter of 2022. And while triamcinolone injections are currently available, they aren’t administered the same way as Xipere. As described above, Xipere comes with a special syringe and needle for suprachoroidal administration.
If you’re currently receiving triamcinolone injections and want to learn more about Xipere, talk to your eye specialist to see if it’s right for you.
How much will Xipere cost?
Xipere isn’t available yet, so we don’t have cost information at this time. It’s also administered by a healthcare provider. That means it’s not a medication that you’ll be able to find at your local pharmacy. And there may be additional costs associated with the procedure, too.
Once Xipere’s cost and insurance coverage is available, your eye specialist may have a better idea of how it’ll compare to the cost of other treatments.
The bottom line
Triamcinolone injections are currently available. But Xipere’s approval gives providers a new option for treating macular edema associated with uveitis. Compared to current medication delivery methods, suprachoroidal injections may offer some potential advantages.
If you’re interested in learning more about Xipere and whether it’s right for you, talk to your eye specialist about your options. Check back with GoodRx as we get closer to Xipere’s official launch for more information about cost and insurance coverage.
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References
Bausch Health Companies. (2021). Bausch + Lomb and Clearside Biomedical announce FDA approval of XIPERE™ (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis.
Clinicaltrials.gov. (2021). Suprachoroidal injection of CLS-TA in subjects with macular edema associated with non-infectious uveitis.
Food and Drug Administration. (2021). Highlights of prescribing information for Xipere.
Gholam, P., et al. (2009). Intravitreal injection of therapeutic agents. Retina: The Journal of Retinal and Vitreous Diseases.
Jermak, C.M., et al. (2007). Triamcinolone acetonide in ocular therapeutics. Survey of Ophthalmology.
Massa, H., et al. (2019). Macular edema associated with non-infectious uveitis: pathophysiology, etiology, prevalence, impact and management challenges. Clinical Ophthalmology.
Moisseiey, E., et al. (2016). The suprachoroidal space: from potential space to a space with potential. Clinical Ophthalmology.
National Eye Institute. (2019). Uveitis.
National Eye Institute. (2020). Vitreous detachment.
Yeh, S., et al. (2020). Efficacy and safety of suprachoroidal CLS-TA for macular edema secondary to noninfectious uveitis. Ophthalmology.
