The treatment was approved in October 2021 and is the first FDA-approved therapy to treat macular edema associated with uveitis via injection to the suprachoroidal space, which provides a more targeted delivery mechanism.
The first approved medicine delivery via injection for suprachoroidal use to treat macular edema associated with uveitis has launched in the United States.
Triamcinolone acetonide injectable suspension (Xipere; Bausch + Lomb and Clearside Biomedical) is a targeted delivery to the suprachoroidal space (SCS) between the sclera and the choroid. FDA approved the treatment October 25, 2021.
Delivering the medicine to the SCS allows for a targeted delivery of the therapy with low levels elsewhere in the eye.1 Traditional routes of delivery, such as intravitreal injections, to the posterior segment of the eye result in the drug diffusing toward non-targeted regions of the eye and more side effects.
"The suprachoroidal space is an untapped frontier in eye health. We are proud to be the pioneers in treating serious retinal diseases by implementing this novel, targeted approach. With this approval, we begin a new era in delivering therapies to the back of the eye," George Lasezkay, PharmD, JD, president and CEO, Clearside, said in a statement. "Our unique approach now has the potential to positively impact this patient population, which previously had no other treatment options approved for this indication."
Clearside developed the SCS Microinjector that is used to deliver the medicine.
The FDA approval was passed on results from the PEACHTREE trial, although Xipere was also studied in the MAGNOLIA and AZALEA trials. MAGNOLIA was a noninterventional extension study and AZALEA was an open-label safety trial.
The results of PEACHTREE were published January 2020 in Ophthalmology.2 It was a phase 3 masked, randomized trial of 160 patients with macular edema associated with uveitis. They were randomized 3:2 to Xipere or placebo with administrations at day 0 and week 12.
By week 24, nearly half of the patients (47%) on Xipere gained ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best-corrected visual acuity (BCVA) vs only 16% in the control arm (P < .001). The researchers found improvements with Xipere occurred early. By week 4 there was a mean change of 9.6 EDTRS letters for patients treated with Xipere vs 1.3 letters in the control arm.
In addition, at least two-thirds of patients in the Xipere arm who had active inflammation at baseline experienced a resolution of inflammation. Only 14% of patients in the Xipere arm required rescue therapy vs 72% in the control arm over the 24 weeks of the study.
The researchers found that 30.2% of patients treated with the therapy had treatment-related adverse events (AEs) vs 12.5% in the placebo arm. The most common ocular AEs were cystoid macular edema (0% in Xipere arm and 17.2% in control arm), eye pain at the time of procedure (12.5% in Xipere arm vs 4.7% in control arm), and elevated intraocular pressure associated with corticosteroid (11.5% in Xipere arm vs 15.6% in control arm).
"The safety and efficacy data of Xipere was demonstrated in multiple clinical studies and its unique suprachoroidal administration approach provides exceptional access and high bioavailability to the posterior segment of the eye," said Steven Yeh, MD, professor of ophthalmology and director of retinal disease and uveitis, Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, and principal investigator of PEACHTREE. "With the approval of Xipere, eye care professionals now have a new and innovative treatment option for their patients with macular edema associated with uveitis."
1. Chiang B, Jung J, Prausnitz. 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
2. 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