Xipere (triamcinolone acetonide) is a corticosteroid medicine given as an eye injection. It's approved to treat macular edema associated with uveitis.
Uveitis refers to inflammation inside the eye. It can affect the front, middle, or back of the eye, or more than one area at once. Left untreated, it can cause fluid buildup in the macula, which is the part of the retina responsible for sharp, central vision. This is called macular edema, a leading cause of vision loss in people with uveitis.
Approved by the FDA in October 2021, Xipere was the first medicine approved for injection into the suprachoroidal space, a thin area between two layers of tissue at the back of the eye.
This article covers how Xipere works, who it's approved for, how it's given, and what clinical studies found about its benefits. You may also want to read about Xipere side effects and how to manage them.
How Does Xipere Work for Uveitic Macular Edema?
Uveitis happens when your immune system causes inflammation inside the eye. It can cause blood vessels in your eye to leak fluid. When that fluid collects in the macula, it causes swelling that blurs or distorts central vision.
Triamcinolone acetonide, the active ingredient in Xipere, is a corticosteroid. Corticosteroids calm down inflammation and help stop the leaking from blood vessels that leads to macular edema.
Corticosteroids used to treat uveitis are typically given as pills you take by mouth, injections into the vitreous (the gel-like substance that fills the middle of the eye), or an implant placed inside the eye. Each of these methods exposes the front part of the eye, including the lens, to the medicine, which is part of why steroid eye treatments are linked to cataracts and increased eye pressure.
Xipere takes a different approach. It's given by a specially trained eye doctor (ophthalmologist or retina specialist) as an injection into a specific part of the eye called the suprachoroidal space. This compartment sits closer to the retina and choroid (the layer of blood vessels that nourishes the retina) and further from the front of the eye. In lab studies, this suprachoroidal approach delivered higher amounts of triamcinolone acetonide to the retina and choroid and lower amounts to the front of the eye and the lens, compared with injecting the same medicine into the fluid inside the eye (intravitreal).
How Is Xipere Given?
Xipere isn't a medicine you take at home. It's given in your health care provider's office as a single injection. It typically takes just a few minutes and is done under local anesthesia to keep it comfortable.
In a clinical trial, participants received two Xipere injections in the study eye, 12 weeks apart. Whether or not you'll need repeat injections is something your health care provider will decide based on how you respond to treatment.
Right after your injection, your provider will check your eye pressure. Afterward, watch for eye redness, pain, sensitivity to light, or new vision changes, and contact your ophthalmologist right away if any of these happen, since they can be signs of a serious eye infection or a detached retina.
Who Is Xipere Approved For?
Xipere is FDA-approved for the treatment of macular edema associated with uveitis. It can be used regardless of which part of the eye the uveitis affects (the front, middle, back, or multiple areas).
Before deciding whether Xipere is a good option for you, your health care provider (usually an ophthalmologist or retina specialist) will consider your specific type of uveitis, how severe your macular edema is, and any other eye conditions or treatments you've tried.
How Was Xipere Studied for Uveitic Macular Edema?
The main study supporting Xipere's approval was called PEACHTREE. It included 160 adults with macular edema caused by noninfectious uveitis (uveitis not caused by an infection).
Here's what the study population looked like at the start of the trial:
- The average age was about 50.
- More participants were women (55%) than men (45%).
- 45% were Asian, 41% were White, and 14% were Black or African American.
- Uveitis affected different parts of the eye across participants: about a quarter had anterior uveitis (front of the eye), more than a third had intermediate uveitis (middle of the eye), about a fifth had posterior uveitis (back of the eye), and about a third had panuveitis (multiple areas).
- All participants had macular edema that affected vision in their study eye, but it was not so severe that they couldn't read at least some letters on an eye chart.
Participants were split into two groups. About 60% received Xipere, and the rest received a sham (fake) procedure that looked like the real injection but delivered no medicine. Neither participants nor the health care providers examining them knew who received which treatment. Both groups could keep taking other uveitis medicines they were already on, such as steroid pills, as long as the dose stayed stable.
What Are the Main Benefits of Xipere Based on Studies?
The study's main goal was to see how many participants gained a meaningful amount of vision, defined as being able to read three more lines on an eye chart than they could at the start of the study, after 24 weeks (about six months).
At 24 weeks:
- 47% of people who got Xipere gained three or more lines of vision.
- 16% of people who got the sham procedure gained three or more lines of vision.
The study used a scan called optical coherence tomography (OCT) to measure how much the macular swelling improved. By 24 weeks, macular thickness dropped by an average of 153 micrometers in the Xipere group, compared with 18 micrometers in the sham group.
Your results may differ from what was seen in clinical studies.
Are There Additional Benefits of Xipere Based on Studies?
The study also tracked some other outcomes beyond the main results.
Improvements with Xipere started early and held up over time:
- By week 4, people who got Xipere had already gained an average of about 10 letters on the eye chart, compared with about one letter for the sham group. That early improvement was maintained through week 24.
- By week 8, about half of people who got Xipere could see 20/40 or better, meaning they could see at 20 feet what someone with normal vision sees at 40 feet. Only about 15% of the sham group reached that level.
- By week 4, about half of people who got Xipere had their macular edema resolve completely (meaning the swelling dropped below a specific thickness threshold on the OCT scan), compared with about 2% of the sham group.
- Over the full 24 weeks, only about 14% of people who got Xipere needed rescue treatment (additional treatment given when the first treatment isn't working well enough), compared with 72% of people who got the sham procedure. Among those who did need rescue treatment, people in the Xipere group typically went longer before needing it.
Your results may differ from what was seen in clinical studies.
Is There Longer-Term Data on Xipere?
The main PEACHTREE study followed people for 24 weeks. Some participants continued into a follow-up study called MAGNOLIA, which looked at Xipere's longer-term safety and effectiveness.
In MAGNOLIA, about half of the people treated with Xipere did not need additional treatment for up to nine months after their last dose. Those who did not need additional treatment also had improvements in vision and reduced eye swelling.
Ask your health care provider what to expect after Xipere treatment, including when you may need follow-up visits or additional treatment.
How Can I Get Xipere? Is Cost Assistance Available?
Xipere requires a prescription and is given by a health care provider, typically an ophthalmologist or retina specialist who is experienced in eye injections.
Bausch + Lomb, the company that distributes Xipere, offers a copay savings program for people with insurance. It may help lower your out-of-pocket cost. Ask your provider's office about enrollment, or call 866-272-8838 to learn more.
