PEACHTREE

24-week phase 3 pivotal trial

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MAGNOLIA

24-week extension study

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AZALEA

24-week open-label safety study

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PEACHTREE

Nonocular adverse reactions reported in ≥5% of patients consisted of headache: XIPERE, 5% (n=5/96); control, 3% (n=2/64)4

No occurrences of endophthalmitis or suprachoroidal hemorrhage in either treatment arm (XIPERE: n=96; CONTROL: n=64)1

Nonocular adverse reactions reported in ≥5% of patients consisted of headache: XIPERE, 5% (n=5/96); control, 3% (n=2/64)4

No occurrences of endophthalmitis or suprachoroidal hemorrhage in either treatment arm (XIPERE: n=96; CONTROL: n=64)1

PEACHTREE POST HOC ANALYSIS

IOP-related adverse events (AEs) with and without rescue therapy4

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Overall, 13.5% of patients treated with XIPERE (13/96) received rescue treatment, compared to 71.9% of control patients (46/64)1

  • All patients in the control arm who experienced AEs related to elevated IOP|| were administered corticosteroid rescue therapy2
In a post hoc analysis, one-half the proportion of patients who received XIPERE without rescue therapy experienced corticosteroid-induced|| AEs related to elevated IOP, compared to control patients who received rescue5
  • ||Includes intraocular pressure increased, ocular hypertension, and glaucoma.
  • All events of elevated IOP not occurring on the day of the sham/XIPERE procedure.

Adverse event profile was consistent across clinical trials3

The 24-week noninterventional extension study MAGNOLIA included patients who had completed the pivotal PEACHTREE study without receiving rescue medication.3

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MAGNOLIA
  • For one patient, the investigator reported cataract subcapsular on the final visit of PEACHTREE and cataract during
    MAGNOLIA, both within the study eye and having the same start date.

Of patients treated with XIPERE who were followed up to 48 weeks:

25% (7/28) had a treatment-emergent adverse event (TEAE) related to cataract2
21.4% (6/28) had a TEAE related to IOP elevations5

  • For one patient, the investigator reported cataract subcapsular on the final visit of PEACHTREE and cataract during
    MAGNOLIA, both within the study eye and having the same start date.

Of patients treated with XIPERE who were followed up to 48 weeks:

25% (7/28) had a treatment-emergent adverse event (TEAE) related to cataract2 21.4% (6/28) had a TEAE related to IOP elevations5

Safety and tolerability of XIPERE were observed up to 24 weeks with no patients experiencing serious ocular adverse events3

In the open-label safety study, no patients discontinued due to an AE and 37 of 38 patients treated with XIPERE™ completed AZALEA.3

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AZALEA

Rate of elevated IOP is consistent with the PEACHTREE pivotal trial.3

IOP=intraocular pressure

 

Indication

XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use is a corticosteroid indicated for the treatment of macular edema associated with uveitis.

Important Safety Information

Patients should be monitored following injection for elevated intraocular pressure. See Dosage and Administration instructions in full Prescribing Information.

  • 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, varicella, mycobacterial infections, and fungal diseases.
  • XIPERE is contraindicated in patients with known hypersensitivity to triamcinolone acetonide or any other components of this product.
  • 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, and should be used cautiously in patients with a history of ocular herpes simplex.
  • Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and hyperglycemia can occur following administration of a corticosteroid. Monitor patients for these conditions with chronic use.
  • In controlled studies, the most common ocular adverse reactions were increased ocular pressure, non-acute (14%), eye pain, non-acute (12%), cataract (7%); increased intraocular pressure, acute (6%), cataract (7%), vitreous detachment (5%), injection site pain (4%) conjunctival hemorrhage (4%), visual acuity reduced (4%), dry eye (3%), eye pain, acute (3%), photophobia (3%), and vitreous floaters (3%), and in 2% of patients: uveitis, conjunctival hyperaemia, punctate keratitis, conjunctival oedema, meibomianitis, anterior capsule contraction, chalazion, eye irritation, eye pruritus, eyelid ptosis, photopsia, and vision blurred.
    The most common non-ocular adverse event was headache (5%).
  • Corticosteroids should be used during pregnancy or nursing only if the potential benefit justifies the potential risk to the fetus or nursing infant.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information.

References

  1. Yeh S, Khurana RN, Shah M, et al. Efficacy and safety of suprachoroidal CLS-TA for macular edema secondary to noninfectious uveitis: phase 3 randomized trial. Ophthalmology. 2020;127(7):948-955.
  2. Khurana RN, Merrill P, Yeh S, et al. Extension study of the safety and efficacy of CLS-TA for treatment of macular oedema associated with non-infectious uveitis (MAGNOLIA). Br J Ophthalmol. 2021;0:1-6.
  3. Henry CR, Shah M, Barakat MR, et al. Suprachoroidal CLS-TA for non-infectious uveitis: an open-label, safety trial (AZALEA) [published online ahead of print]. Br J Ophthalmol. 2021;0:1-5.
  4. XIPERE [prescribing information]. Alpharetta, GA: Clearside Biomedical, Inc.; 2021.
  5. Data on file. Clearside Biomedical, Inc.

Indication

Important Safety Information

XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use is a corticosteroid indicated for the treatment of macular edema associated with uveitis.

Important Safety Information

Patients should be monitored following injection for elevated intraocular pressure. See Dosage and Administration instructions in full Prescribing Information.

  • 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, varicella, mycobacterial infections, and fungal diseases.

Patients should be monitored following injection for elevated intraocular pressure. See Dosage and Administration instructions in full Prescribing Information.