Clearside presents positive Phase 2 extension study data
Clearside Biomedical (NASDAQ:CLSD) presented positive data from an extension study of patients who participated in the completed Phase 2 trial of its suprachoroidal CLS-TA in combination with intravitreal Eylea for the treatment of macular edema associated with retinal vein occlusion (RVO).
The data was presented by Dr. Charles Wykoff at the 40th Annual Macula Society Meeting in Singapore.
As previously reported, patients in the combination arm of the TANZANITE achieved both additional visual acuity improvements and macular edema reductions over a three-month period following initial dosing, compared with patients in the Eylea-only control arm.
"Based on the fact that so few patients in the TANZANITE combination arm received retreatment, and cognizant of the substantial unmet need associated with frequent office visits and injections required in this patient population, our team conducted an extended evaluation to better assess the duration of effect of the combination treatment and the potential to reduce the burden of therapy,” Daniel White, president and CEO of Clearside, said in a statement.
The objective of the extension study was to assess the durability of suprachoroidal CLS-TA in combination with intravitreal Eylea for an additional six months following completion of the TANZANITE trial.
Using data from the TANZANITE trial and the extension study, time to first RVO re-treatment following the baseline dosing in TANZANITE was determined for patients in both arms.
In the preliminary analysis presented at the conference, 17 of the 23 patients in the combination arm of the TANZANITE trial, or 74%, did not receive any additional treatment over the nine-month period, compared with only 4 of 23 patients, or 17%, in the Eylea arm.
Dr. Wykoff said that 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.”
Mr. White agreed. “We are encouraged by these data, which suggest that suprachoroidal CLS-TA in combination with intravitreal Eylea for the treatment of RVO in treatment-naïve patients has the potential to not only provide better vision and a faster onset of action, but also, based on the extension study, to lower the need for retreatment when compared to intravitreal Eylea monotherapy.”
Clearside launched the first of two planned Phase 3 RVO clinical trials, known as SAPPHIRE, in the first quarter of 2017.