safety safety

XIPERE^® has a proven
safety profile

Assessed in real-world use and in 3 clinical studies:
PEACHTREE, MAGNOLIA, and AZALEA.^1-4

See the Clinical Trial Data

PEACHTREE

24-week phase 3 pivotal trial

Review PEACHTREE study design >

MAGNOLIA

24-week extension study

Review MAGNOLIA study design >

AZALEA

24-week open-label safety study

Review AZALEA study design >

IRIS® REGISTRY

48-week safety analysis

Review IRIS study design >

IRIS® REGISTRY

Elevation in IOP after XIPERE® administration over the 48-week period was low in both a controlled clinical study setting and in real-world practice⁴*

*The results of this study are based on real-world data and should be considered in the context of the limitations of this type of evidence. While these findings provide insights into the real-world performance of XIPERE®, they may not be directly comparable to results from randomized controlled trials.

^†MAGNOLIA is a 24-week noninterventional extension study which included patients who had completed the pivotal PEACHTREE study without receiving rescue medication.

IRIS® REGISTRY

⁴*

*The results of this study are based on real-world data and should be considered in the context of the limitations of this type of evidence. While these findings provide insights into the real-world performance of XIPERE®, they may not be directly comparable to results from randomized controlled trials.

^†MAGNOLIA is a 24-week noninterventional extension study which included patients who had completed the pivotal PEACHTREE study without receiving rescue medication.

~43% of the IRIS® population followed in the registry had glaucoma/ocular hypertension⁴

28% of the patients had a baseline IOP >22 mmHg⁴

Review IRIS study design >

PEACHTREE

Ocular adverse reactions reported in ≥2% of patients⁵

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

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

PEACHTREE

⁵

^‡Includes intraocular pressure increased and ocular hypertension.

^§Defined as not occurring on the day of the injection procedure or occurring on the day of the injection procedure and not resolving the same day.

^∥Includes cataract, cataract cortical, and cataract subcapsular.

^¶Defined as occurring on the day of the injection procedure and resolving the same day.

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

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 therapy⁵

Review PEACHTREE study design >

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^# AEs related to elevated IOP**, compared to control patients who received rescue⁶

^#Includes intraocular pressure increased, ocular hypertension, and glaucoma.

**All events of elevated IOP not occurring on the day of the sham/XIPERE® procedure.

Proportion of patients experiencing AEs related to elevated IOP^|| by rescue use⁶

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

Proportion of patients experiencing AEs related to elevated IOP^|| by rescue use⁶

In a post hoc analysis, one-half the proportion of patients who received XIPERE® without rescue therapy experienced^# AEs related to elevated IOP**, compared to control patients who received rescue⁶

^#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

Review MAGNOLIA study design >

MAGNOLIA

Non–IOP related ocular adverse events in the study eye⁶

⁶

^††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 elevations⁶

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

Review AZALEA study design >

AZALEA

Ocular adverse events in the study eye³

³

^‡‡Cataract includes the medDRA preferred terms cataract, cataract subcapsular, and cataract nuclear.

^§§Eye pain includes eye pain and injection site pain.

^∥∥Elevated IOP includes IOP increased and ocular hypertension.

^¶¶Includes all events of elevated IOP that did not occur on the day of the procedure.

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

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.

Please click here for full Prescribing Information.

IOP=intraocular pressure.

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

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.Singer M, et al. Presented at: 57th Annual Retina Society Scientific Meeting. September 11-15, 2024; Lisbon, Portugal.

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

6.Data on file. Clearside Biomedical, Inc.

Study Designs

IRIS® Registry Study

OBJECTIVE: To extend understanding of the effect of a suprachoroidal injection of XIPERE® on intraocular pressure (IOP) in UME patients in clinical practice.^1*

METHODS: Patients ≥18 years with noninfectious UME and a suprachoroidal injection of XIPERE® from January 2022-December 2023 were identified in the IRIS® Registry

Elevation in IOP post-XIPERE® was monitored within 48 weeks following injection
Elevation was recorded with respect to the nearest baseline IOP reading prior to injection administration

*The results of real-world studies should be considered in the context of the limitations of this type of evidence. While these findings provide insights into the real-world performance of XIPERE®, they may not be directly comparable to results from randomized controlled trials.

Reference

Singer M, et al. Presented at: 57th Annual Retina Society Scientific Meeting. September 11-15, 2024; Lisbon, Portugal.

Enrolled patients had:

Intraretinal or subretinal fluid²
Retinal thickness of ≥300 μm in the central subfield²
BCVA of ≥5 and ≤70 ETDRS letters²

Summary

Phase 3 masked, randomized study²

After a 2-week screening period, eligible patients returned to the clinic for the baseline visit (Day 0) when they were randomly assigned in a 3:2 ratio to treatment or control. The control group underwent a sham procedure to maintain masking²

Patients received a single unilateral suprachoroidal injection of XIPERE®, 4 mg (0.1 mL of 40 mg/mL), or a unilateral sham at Day 0 and at Week 12²

The PEACHTREE trial included patients with macular edema associated with uveitis in all anatomical locations: anterior, intermediate, posterior, and panuveitis^1,2

References

Data on file. Clearside Biomedical, Inc.
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.

Enrolled patients had:

Completed PEACHTREE²
DID NOT receive rescue medication²
Sites with high enrollment in PEACHTREE were selected to participate in MAGNOLIA²

Summary

Multicenter, non-interventional, 6-month extension study for patients who successfully completed PEACHTREE without requiring rescue treatment²

The final visit of PEACHTREE was the crossover visit (Day 0) of MAGNOLIA, with follow-up visits conducted every 6 weeks²

Patients were discontinued from MAGNOLIA if rescue therapy became necessary to treat uveitis²

References

Data on file. Clearside Biomedical, Inc.
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.

Enrolled patients had:

Active or inactive noninfectious uveitis in any anatomic location, with or without macular edema (Note: XIPERE® is not indicated in the absence of macular edema)¹
BCVA of ≥5 ETDRS letters¹

Summary

Phase 3 open-label, single-arm, prospective, multicenter safety study¹

Eligibility was determined up to 30 days before baseline (Day 0). Twenty out of 38 enrolled patients had macular edema based on a CST of >300 μm¹

Eligible patients received a single unilateral suprachoroidal injection of XIPERE®, 4 mg (0.1 mL of 40 mg/mL) on Day 0 and at Week 12¹

References

Henry CR, Shah M, Barakat MR, et al. Suprachoroidal CLS-TA for non-infectious uveitis: an open-label, safety trial (AZALEA). Br J Ophthalmol. 2021;0;1-5.
XIPERE® [prescribing information]. Alpharetta, GA: Clearside Biomedical, Inc.

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.

XIPERE® has a proven safety profile

PEACHTREE

MAGNOLIA

AZALEA

IRIS® REGISTRY

IRIS® REGISTRY

IRIS® REGISTRY

Elevation in IOP after XIPERE® administration over the 48-week period was low in both a controlled clinical study setting and in real-world practice

~43% of the IRIS® population followed in the registry had glaucoma/ocular hypertension4

PEACHTREE

PEACHTREE

Ocular adverse reactions reported in ≥2% of patients

PEACHTREE POST HOC ANALYSIS

IOP-related adverse events (AEs) with and without rescue therapy5

Adverse event profile was consistent across clinical trials3

MAGNOLIA

Non–IOP related ocular adverse events in the study eye

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

AZALEA

Ocular adverse events in the study eye

Indication

Important Safety Information

References

Indication

Important Safety Information

XIPERE^® has a proven
safety profile

~43% of the IRIS® population followed in the registry had glaucoma/ocular hypertension⁴

IOP-related adverse events (AEs) with and without rescue therapy⁵

Adverse event profile was consistent across clinical trials³

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