Steven Yeh, MD, presented data from the phase 3 PEACHTREE trial at the American Society of Retina Specialists annual meeting as a late-breaking oral presentation. This was the first public presentation of data from PEACHTREE, a pivotal phase 3 trial of suprachoroidal CLS-TA in patients with macular edema associated with noninfectious uveitis.
Suprachoroidal CLS-TA is Clearside’s proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via the suprachoroidal space, or SCS. More information about Clearside Biomedical and their suprachoroidal approach to the treatment of serious eye diseases is available at www.clearsidebio.com.
During his presentation, Dr. Yeh, Louise M. Simpson Professor of Ophthalmology and Uveitis and Vitreoretinal Surgery Director, Uveitis and Vasculitis Service at the Emory Eye Center, Emory University, reviewed efficacy and safety data from the phase 3 PEACHTREE trial. As summarized during his final slide, key takeaways from the trial are:
- Suprachoroidal CLS-TA met the primary study endpoint, with a significantly greater proportion of subjects (47%) vs. control (16%) with ≥15 ETDRS BCVA (3 lines or greater visual acuity) gain at 6 months (P < 0.001)
- CLS-TA significantly improved macular edema in uveitis patients (P < 0.001)
- Vast majority of patients in CLS-TA arm did not require rescue therapy during study
- Favorable safety profile overall with no SAEs attributable to suprachoroidal CLS-TA
- Low rates of elevated IOP and cataract
In addition to reviewing the primary efficacy and safety results disclosed in March 2018, Dr. Yeh will share additional data from the phase 3 PEACHTREE trial. These data provide further support for CLS-TA as a potential treatment option for macular edema associated with noninfectious uveitis.
The additional efficacy data presented at ASRS include: anatomical data (significant reductions from baseline in retinal thickness, resolution of macular edema in at least 50% of patients at every visit in the trial, and that approximately 50% or more patients were able to read at least 70 ETDRS letters (20/40 or better) in the CLS-TA arm. In addition, the trial showed that the vast majority (85%) of patients in the CLS-TA arm did not require rescue therapy during the study.
The additional safety data presented at ASRS included a review of serious adverse events and ocular adverse events from the study and a detailed analysis of elevated IOP and cataract adverse event rates. The elevated IOP rate for the CLS-TA arm was 11.5% (11/96), and 15.6% (10/64) of patients for the sham arm through the 24-week trial. However, among patients who received rescue medication in the form of local corticosteroids during the study, 26.3% (10/38) in the sham group experienced elevated IOP adverse events (slides 18, 19). New or worsening cataracts occurred with similar frequency between the CLS-TA and sham groups and there were no cataract-related surgeries in the trial.