Safety & Tolerability | XIPERE® (triamcinolone acetonide injectable suspension)

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 >

PEACHTREE

Ocular adverse reactions reported in ≥2% of patients⁴

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

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 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

Review MAGNOLIA study design

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

Review AZALEA study design

AZALEA

Ocular adverse events in the study eye³

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%), 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

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.
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.
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.
XIPERE^® [prescribing information]. Alpharetta, GA: Clearside Biomedical, Inc.; 2022.
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.

XIPERE® has a proven safety profile

PEACHTREE

24-week phase 3 pivotal trial

MAGNOLIA

24-week extension study

AZALEA

24-week open-label safety study

PEACHTREE

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

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

Adverse event profile was consistent across clinical trials3

MAGNOLIA

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

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

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

AZALEA

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

Indication

Important Safety Information

References

Indication

Important Safety Information

Important Safety Information

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

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

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

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

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

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

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

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

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

XIPERE^® has a proven safety profile

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

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

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

Adverse event profile was consistent across clinical trials³

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

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

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

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

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

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

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

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

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

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

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

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

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