XIPERE

In animal studies, data demonstrated that suprachoroidal injections resulted in larger amounts in total of triamcinolone acetonide found in the sclera, choroid, retinal pigment epithelial and retina, than with intravitreal injections of triamcinolone acetonide. Lower amounts of triamcinolone acetonide were found in the anterior segment and lens as compared to intravitreal injections of triamcinolone acetonide. Plasma triamcinolone acetonide concentrations were evaluated in 19 patients with dosin...

The efficacy of XIPERE ® was assessed in a 6-month, randomized, multicenter, double-masked, sham-controlled study in patients with macular edema associated with anterior-, intermediate-, posterior-, or pan-uveitis. Patients were treated at baseline and Week 12. The primary efficacy endpoint was the proportion of patients in whom best corrected visual acuity (BCVA) had improved by ≥ 15 letters from baseline after 24 weeks of follow-up (Table 2).

Table 2Number of Patients with ≥ 15 Letters Improvement from Baseline at Week 24 * The p-value was based on a Cochran Mantel Haenszel test for genera...

In controlled studies, the most common adverse reactions reported by ≥ 10% of patients and at a rate greater than control included elevated intraocular pressure and eye pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot b...

Ocular or periocular infections ( 4.1 ) Hypersensitivity to triamcinolone or any component of this product ( 4.2 ) 4.1 Ocular or Periocular Infections XIPERE ® is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varic...

Potential Corticosteroid-Related Effects : Use of corticosteroids may produce cataracts, increased intraocular pressure, and glaucoma. ( 5.1 ) 5.1 Potential Corticosteroid-Related Effects Use of corticosteroids may produce cataracts, increased intraocular pressure, and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex. Corti...