Description
What is Xipere (triamcinolone acetonide injectable suspension) for?
Xipere (triamcinolone acetonide injectable suspension) is used for the treatment of macular edema associated with uveitis, a type of eye inflammation, by reducing inflammation in the suprachoroidal space of the eye.
How does Xipere (triamcinolone acetonide injectable suspension) work?
Xipere (triamcinolone acetonide injectable suspension) contains the active ingredient triamcinolone acetonide, which is a corticosteroid that blocks inflammation in the suprachoroidal space of the eye. Macular edema occurs when fluid accumulates in the macula, a region of the retina, leading to swelling and distortion of vision. By reducing inflammation caused by uveitis, Xipere can reduce macular edema and improve visual clarity. The drug is injected into the suprachoroidal space between the sclera and choroid, allowing it to reach the back of the eye precisely.
How is Xipere (triamcinolone acetonide injectable suspension) taken?
The recommended administration of Xipere (triamcinolone acetonide injectable suspension) is 4 mg (0.1 mL) injected into the suprachoroidal space (SCS) by a trained healthcare provider using the SCS Microinjector® for precise injection. Detailed information about dosage and administration can be found in the official prescribing information provided in the references section. Please note that specific dosing should be discussed with your doctor based on individual needs.
Are there any known side effects of Xipere (triamcinolone acetonide injectable suspension)?
According to the prescribing information, the most commonly reported side effects (observed in ≥10% of patients) of Xipere (triamcinolone acetonide injectable suspension) include:
– Increased pressure in the eye
– Eye pain
Xipere is not suitable for patients who have active or suspected ocular or periocular infections such as viral diseases of the cornea and conjunctiva, mycobacterial infections, fungal diseases, and active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella. Furthermore, it is not recommended for patients with a known hypersensitivity to triamcinolone acetonide or any other components present in Xipere. For further details on side effects and adverse reactions, please consult the official prescribing information.
Clinical trials
Xipere (triamcinolone acetonide injectable suspension) was granted approval by the Food and Drug Administration (FDA) for the management of uveitis-related macular edema after successful results from PEACHTREE clinical trial (NCT02595398) were obtained.
PEACHTREE was a double-masked, randomized, multicenter phase 3 clinical trial that enrolled 160 patients with uveitis-associated macular edema. In a 3:2 ratio, patients received either a unilateral suprachoroidal injection of Xipere 4mg or placebo injection on day 0, followed by another injection on week 12.
Outcome
The primary endpoint was the proportion of patients at week 24 with an improvement of at least 15 letters in the best-corrected visual acuity (BCVA) from baseline. BCVA refers to the most superior vision range that an individual can obtain, like when reading letters on an eye chart, with correction such as glasses.
According to the study results, Xipere demonstrated a substantial improvement in BCVA compared to placebo. At least a 15-letter improvement was noted among 47% of Xipere-treated patients in contrast to only 16% of those in the control group.
For detailed information on safety and efficacy of Xipere for the approved indication, please take a look at the summary of product characteristics below and the resource section.
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