Bausch + Lomb HomeExternal link

Significant and sustained BCVA improvements in clinical trials with XIPERE®2-4

See the Clinical Trial Data

Data from the Intelligent Research in Sight (IRIS®) Registry demonstrates the durability of XIPERE® in a real-world setting6

Review IRIS study design >

RESULTS

RESULTS

~88% of XIPERE®-treated eyes did NOT receive an injected/implanted corticosteroid by Week 246

View the Data

"At risk" describes the number of patient eyes that have not been censored or received rescue therapy.

"Censored" describes the number of patient eyes for whom receipt of rescue therapy cannot be determined due to loss to follow-up.

"Events" describes the number of patient eyes that received rescue therapy.

RESULTS

~75% of XIPERE®-treated eyes did NOT receive ANY corticosteroid by Week 246

View the Data

people chart

†In PEACHTREE, all subjects had a second injection at Week 12.2,3

The limitations of this study include lack of randomization and the retrospective nature of the data.

only-2percentage

of XIPERE®-treated patients received a second suprachoroidal injection
at 12 weeks6†

†In PEACHTREE, all subjects had a second injection at Week 12.2,3

Pivotal trial PEACHTREE demonstrated results at Week 243

Review PEACHTREE study design >

PRIMARY ENDPOINT

XIPERE® delivered a significant BCVA improvement
of ≥15 ETDRS letters from baseline at Week 243

47% of patients treated with XIPERE® achieved this compared with 16% of patients in the control group
(n=96 and n=64 respectively; P<0.01).3

Proportion of patients who gained ≥15 ETDRS letters from baseline at Week 243

Bar chart showing 47% of XIPERE® TREATED patients achieved a significant BCVA improvement of ≥15 letters from baseline vs 16% of patients in the control group.

Secondary endpoint

Patients experienced a mean reduction of ~153 μm in central subfield thickness (CST) at Week 24 with XIPERE® vs ~18 μm in the control group (n=96 and n=64 respectively)3

Mean change from baseline in CST3

Line graph comparing the mean CST change from baseline for XIPERE® TREATED patients and patients in the control group.

View CST Data

PEACHTREE POST HOC ANALYSIS

Mean BCVA gain was greater for patients treated with XIPERE®,
relative to control, regardless of anatomical location of uveitis at
Week 247

Mean change from baseline in BCVA at Week 24 by anatomical location of uveitis7

At baseline, 41 (25.6%) patients had anterior uveitis, 57 (35.6%) had intermediate, 35 (21.9%) had posterior, and 52 (32.5%) had panuveitis.3

View BCVA Data

XIPERE® delivered durability

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

Review MAGNOLIA study design >

Primary endpoint

The primary endpoint was time to rescue therapy relative to the date of the first of two quarterly treatments in PEACHTREE. Once patients received rescue medication, they were discontinued from the study.

  • 344 days was the median time to rescue for patients treated with XIPERE® (n=28)
  • Additionally, 50% of patients treated with XIPERE® completed the study by reaching the Week 48 visit without rescue medication

344 DAYS

median time to rescue for patients treated with XIPERE®

(n=28)

ADDITIONAL ENDPOINTS

Patients completing MAGNOLIA maintained a mean BCVA improvement of 12 letters for 9 months after the second and final dose of XIPERE®, which was received at Week 12 (n=14).4

Mean change in BCVA4,7

Line graph showing the mean change in BCVA from baseline to Week 48 for patients treated with XIPERE®.

View BCVA Data

Patients treated with XIPERE® maintained mean CST reductions up to 9 months after their last injection (n=13).4

Mean CST through Week 484,7

Line graph showing the CST from baseline through to Week 48 for patients treated with XIPERE®.

View CST Data

MAGNOLIA POST HOC ANALYSIS
A Kaplan-Meier analysis was performed to assess the probability of rescue therapy being required over the entire 48-week period. This analysis also included patients from PEACHTREE who were not enrolled in MAGNOLIA.4

Kaplan-Meier survival plot of the time to rescue medication4

Kaplan-Meier survival plot of the time to rescue medication for patients treated with XIPERE®.

View Kaplan-Meier Chart

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%), 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.

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.

BCVA=best-corrected visual acuity, ETDRS=early treatment diabetic retinopathy study.

References

1.Smith JR, et al. Ophthalmology. Published online April 20, 2024.

2.XIPERE® [prescribing information]. Alpharetta, GA: Clearside Biomedical, Inc.

3.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.

4.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. 2022;106(8):1139-1144.

5.Chiang B, Jung JH, Prausnitz MR. The suprachoroidal space as a route of administration to the posterior segment of the eye. Adv Drug Deliv Rev. 2018;126:58-66.

6.Singer M, et al. Presented at: 47th Annual Macular Society Meeting; February 7-10, 2024; Palm Springs, California.

7.Data on file. Clearside Biomedical, Inc.

See More

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.