I wanted to personally welcome you to this special edition of Retinal Physician. For a long time, there has been interest in the suprachoroidal space, also known as the SCS, which is located between the sclera and the choroid and is collapsed under normal physiological conditions. Research has demonstrated that medicine may be delivered to this potential space, allowing it to reach the posterior tissues.1
It truly is a new era in retinal therapeutics. At Bausch + Lomb, we are excited to be able to offer Xipere, which is now available for patients with uveitic macular edema. Xipere is the first and currently the only treatment approved for delivery via the suprachoroidal space. What’s most exciting is that it’s certainly not the last. Here are some highlights from the clinical trials:
Significant and Sustained BCVA Improvements Seen in Clinical Trials With Xipere*2-4
- Improvement of ≥15 Early Treatment Diabetic Retinopathy Study letters from baseline at week 24 in 47% of Xipere patients compared with 16% in the control group (n=96 and n=64 respectively; P<.01).2
Xipere Delivers Durability4
- 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.
Xipere has a proven safety profile as assessed in 3 trials: PEACHTREE, MAGNOLIA, and AZALEA.
In the pivotal trial, PEACHTREE, the most common adverse reactions reported by ≥10% of patients and at a rate greater than control included elevated intraocular pressure (14%) and eye pain (12%).2,3
In this issue, you’ll find contributions on topics such as the following:
- Suprachoroidal injections and drug delivery.
- Suprachoroidal drug delivery: a new era in retinal therapeutics.
- Suprachoroidal delivery of ocular drug and gene therapy.
- Suprachoroidal drug delivery in the treatment of noninfectious uveitis: current practice and future directions.
Overall, the potential benefits of using the SCS pathway are clear1,5:
- Targeted: Circumferential and posterior spreading of the drug following injection.
- Accessible: Potential for high bioavailability of drug in the choroid, retinal pigment epithelium, and retina.
- Contained: Compartmentalization of drug away from other tissues, potentially reducing risk of certain side effects.
This special issue is packed with information to help you further explore this innovative pathway, and we hope you join your colleagues in embracing and employing the suprachoroidal space in your appropriate patients. If you’re interested in learning more about Xipere, you can find more data at xipere.com or by talking to a Bausch + Lomb sales representative. RP
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.
Please see additional Important Safety Information on following page.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch .
Please see brief summary of Prescribing Information on page 29 of this publication.
*Phase 3 study design: 6-month, randomized, multicenter, double-masked, sham-controlled study in patients with macular edema associated with anterior-, intermediate-, posterior-, or pan-uveitis. 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 masking. 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.1
*24-Week Extension Study Design: Multicenter, non-interventional, 6-month extension study for patients who successfully completed the Phase 3 study without requiring rescue treatment. The final visit of the Phase 3 study was the crossover visit (Day 0) of this study with follow-up visits conducted every 6 weeks.3
XIPERE® and SCS® are trademarks of Clearside Biomedical, Inc. used under license. © 2022 Bausch & Lomb Incorporated or its affiliates. XIP.0096.USA.22
REFERENCES
- 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. doi:10.1016/j.addr.2018.03.001
- Clearside Biomedical, Inc. XIPERE® [prescribing information]. 2021.
- 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. doi:10.1016/j.ophtha.2020.01.006
- 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) [published online ahead of print, 2021 Mar 12]. Br J Ophthalmol. 2021;bjophthalmol-2020-317560. doi:10.1136/bjophthalmol-2020-317560
- Rai Udo J, Young SA, Thrimawithana TR, et al. The suprachoroidal pathway: a new drug delivery route to the back of the eye. Drug Discov Today. 2015;20(4):491-495. doi:10.1016/j.drudis.2014.10.010
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