Preliminary results from an extension study of Clearside Biomedical’s phase 2 TANZANITE trial show continued benefits of their proprietary triamcinolone acetonide formulation when used as an adjunct to aflibercept for treatment of macular edema (ME) associated with retinal vein occlusion (RVO).
The data, presented at the 2017 Macula Society Meeting by investigator Charles C. Wykoff, MD, PhD, extends the durability of the combination treatment to 9 months.
The principal TANZANITE findings were derived from 46 treatment-naïve patients randomized to receive either concomitant suprachoroidal administration of triamcinolone acetonide (CLS-TA) and intravitreal aflibercept, or aflibercept alone (control). After an initial dosing period, combination eyes showed better improvement in visual acuity and ME reduction over a 3-month follow-up compared with control eyes.
The original trial also met its primary endpoint of reducing retreatment burden, as patients in the combination arm required 60% fewer additional aflibercept injections than the control arm (P=0.013). Of 23 patients in each group, 18 (78%) of combination eyes required no additional treatment over 3 months, compared with only 7 (30%) of control eyes (P=0.003).
This noninterventional extension study included 31 total patients from both groups who received no additional aflibercept during the initial 3 months of TANZANITE, and followed them for another 6 months. The authors assessed time to RVO retreatment as well as changes in vision, central retinal thickness and IOP by reviewing subjects’ electronic medical records.
According to the preliminary analysis, 17 of the 23 combination arm patients (74%) did not receive any additional treatment up to month 9, compared with 4 of 23 control patients (17%).
“While further study is needed, the data from the TANZANITE trial and the Extension Study imply that suprachoroidal CLS-TA in combination with intravitreal Eylea may result in improvements in vision seen as early as month 1 and maintained through month 3, as well as a substantial prolongation of treatment interval,” said Dr. Wykoff. “To that end, Clearside launched the first of two planned Phase 3 RVO clinical trials, known as SAPPHIRE, in the first quarter of 2017.”