U.S. Food and Drug Administration (FDA)-Approved Indications

Xipere is a corticosteroid indicated for the treatment of macular edema associated with uveitis.

Triamcinolone acetonide injectable suspension is available as Xipere (Cleaside Biomedical, Inc.) which is a sterile, preservative-free, injectable suspension for use with the SCS Microinjector. Triamcinolone acetonide functions primarily as a corticosteroid hormone receptor agonist with immunosuppressive and anti-inflammatory activity (Clearside Biomedical, 2021).

According to the prescribing information, triamcinolone acetonide injectable suspension (Xipere) carries the following contraindications:

Per the prescribing information, warnings and precautions include the following:

Per the prescribing information, the most common adverse reactions (≥10%), in controlled studies and at a rate greater than control, included elevated intraocular pressure and eye pain.

On October 25, 2021, the United States Food and Drug Administration (FDA) approved Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis. The FDA approval of Xipere was based on supporting data from the PEACHTREE pivotal study.

Yeh and Shah (2020) evaluated the efficacy and safety of Xipere in the PEACHTREE sudy, a 6-month pivotal phase 3 randomized, multicenter, double-masked, sham-controlled trial, consisting of 160 participants with macular edema (ME) secondary to noninfectious uveitis (i.e., anterior-, intermediate-, posterior-, or pan-uveitis). Additionally, participants were required to have a best-corrected visual acuity (BCVA) of 5 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent, 20/800) and 70 or fewer ETDRS letters read (Snellen equivalent, 20/40 ) in the sudy eye. The participants were randomized 3:2 to suprachoroidally injected triamcinolone acetonide formulation (CLS-TA) 4 mg, which was supsension of triamcinolone acetonide, or sham treatment, with administrations at day 0 and week 12. The primary efficacy outcome was improvement from baseline in BCVA by ≥ 15 letters after 24 weeks of follow up. The secondary efficacy outcome was reduction from baseline in central subfield thickness (CST) after 24 weeks. The results were as follow: 47% of participants gained 15 or more ETDRS letters in BCVA in the CLS-TA arm and 16% in the control arm (p<0.001), meeting the primary endpoint, and mean reductions in CST from baseline were 153 μm versus 18μm (p<0.001), respectively. There was an absence of serious adverse events (AEs) related to treatment. Corticosteroid-associated AEs of elevated intraocular pressure were noted in 11.5% and 15.6% of the CLS-TA and control arms, and cataract AE occurrence was comparable as 7.3% and 6.3%, respectively. The study investigators concluded that participants in the CLS-TA study arm demonstrated clinically significant improvement in vision relative to the sham procedure, thereby, supporting the efficacy of suprachoroidal injection of CLS-TA for the treatment of ME in a vision-threatening disorder.

Thomas et al (2022) stated that macular edema due to non-infectious uveitis is a sight-threatening complication that is routinely treated with corticosteroids. Triamcinolone acetonide injectable suspension for supra-choroidal use (Xipere) is an alternative therapeutic option for patients with non-infectious uveitis associated macular edema. These investigators described the recently FDA-approved triamcinolone acetonide injectable suspension that can be injected into the supra-choroidal space, which allows for therapeutic targeting of the retina and choroid. The authors concluded that supra-choroidal administration of triamcinolone acetonide has shown improvement in vision and inflammation in studies with non-infectious uveitis associated macular edema. This unique delivery method suggested the potential to decrease side effects of anterior segment exposure such as glaucoma and cataract, but head-to-head studies are needed for further investigation of safety and effectiveness. Furthermore, there are promising prospective studies underway for use of the supra-choroidal space for other diseases including macular degeneration, diabetic macular edema (DME), and ocular tumors.

Criteria for Initial Approval

Macular edema associated with uveitis

Aetna considers triamcinolone acetonide injectable suspension (Xipere) medically necessary for the treatment of macular edema associated with uveitis when

of the following criteria are met:

Aetna considers all other indications as experimental and investigational.

Continuation of Therapy

Aetna considers continuation of triamcinolone acetonide injecable suspension (Xipere) therapy medically necessary for an indication listed in Section I when the member meets all initial selection criteria and has demonstrated a positive clinical response to therapy (e.g., improvement or maintenance in best corrected visual acuity [BCVA] or visual field, reduction or maintenance in central subfield thickness (CST), a reduction in the rate of vision decline or the risk of more severe vision loss, reduction in inflammation).

Dosage and Administration

Triamcinolone acetonide injectable suspension is available as Xipere 40 mg/mL in a single-dose vial.

Macular Edema Associated with Uveitis

The recommended dosage is 4 mg (0.1 mL) administered as a suprachoroidal injection.

Source: Bausch & Lomb Americas, 2022