Biopharmaceutical firm Clearside Biomedical (CLSD 10.81, +2.99, +38.3%) trades markedly higher today in reaction to meeting its primary and all secondary endpoints in its Phase 3 clinical trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis. The gist of the data holds that 47% patients who received the dosage of CLSD’s suprachoroidal CLS-TA gained 15 letters of visual acuity compared to 16% of patients who underwent a placebo procedure.
Suprachoroidal CLS-TA was generally well tolerated, with no treatment-related serious adverse events reported in the trial. The Phase 3 pivotal clinical (“PEACHTREE”) trial enrolled 160 patients; of the 160 patients enrolled, 96 patients were randomized to the treatment arm to receive two 4.0 mg doses of suprachoroidal CLS-TA 12 weeks apart, and 64 patients were randomized to undergo sham procedures at the same 12-week interval. Patients were evaluated every four weeks for a total of 24 weeks, and a total of 155 patients, or 97% of those enrolled, completed the full evaluation period of the trial.
In the PEACHTREE trial, 47% of patients who received suprachoroidal CLS-TA every 12 weeks gained at least 15 letters in best corrected visual acuity, as measured using the Early Treatment of Diabetic Retinopathy Study scale, from baseline at week 24, compared to 16% of patients who underwent a sham procedure. This improvement, which was the primary endpoint of the trial, was statistically significant (p < 0.001). Further, in terms of improvements in BCVA, the mean change from baseline was better in the treatment arm than the sham arm at each monthly evaluation. The mean improvement from baseline was maintained throughout the evaluation period, with 9.6 letters gained at week 4 and 13.7 letters at week 24 in the active arm, compared to 1.2 letters at week 4 and 2.9 letters at week 24 in the control arm, respectively.
For the other key secondary endpoint, administration of suprachoroidal CLS-TA resulted in a mean reduction from baseline of 157 microns in central subfield thickness at week 24 in the active arm compared to a 19 micron mean reduction in the sham arm, a result that was also statistically significant (p < 0.001).
The company currently expects to submit a new drug application for suprachoroidal CLS-TA in patients with macular edema associated with uveitis to the FDA in the fourth quarter of 2018, and it is also evaluating a number of options for submissions to regulatory agencies in additional territories outside of the United States.