Clearside Biomedical (NSDQ:CLSD) touted preliminary data from a non-interventional and retrospective trial of patients who participated in the completed Phase II trial of CLS-TA for suprachoroidal administration.
Clearside’s formulation of triamcinolone acetonide, in combination with intravitreally administered Eylea, was evaluated as a treatment for macular edema associated with retinal vein occlusion.
The company’s Phase II Tanzanite trial enrolled 46 treatment-naïve patients with RVO and included a branch of patients who received CLS-TA and intravitreal Eylea and a control arm of patients receiving only intravitreal Eylea.
Clearside previously reported that patients in the combination arm experienced visual acuity improvements and macular edema reductions over a 3-month period compared to patients in the 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,” president & CEO Daniel White said in prepared remarks.
In the company’s Extension study, Clearside evaluated the durability of suprachoroidal CLS-TA in combination with intravitreal Eylea for the 6 months following the Tanzanite trial.
Patients with RVO who participated in the Tanzanite trial and did not receive additional Eylea treatment during the 3-month trial period were eligible to participate in the Extension trial.
In the preliminary analysis of the Extension trial, 17 of the 23 patients in the combination arm of the Tanzanite trial did not receive additional treatment over the 9-month period compared to 4 of the 23 patients in the Eylea arm.
“As RVO is one of the most aggressive retinal vascular diseases that can lead to vision impairment and potential permanent vision loss, there is a strong need to develop new treatment approaches that are both effective and more durable,” Dr.Charles Wykoff said. “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. Further research is needed to fully establish the potential clinical benefit of this therapeutic approach. To that end, Clearside launched the 1st of 2 planned Phase III RVO clinical trials, known as Sapphire, in the 1st quarter of 2017.”
“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,” White added.