Clearside posts positive top line pivotal results in non-infectious uveitis
Clearside Biomedical (NASDAQ:CLSD) reported positive top line results from its Phase 3 clinical trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis.
Clearside enrolled 160 patients in the pivotal PEACHTREE trial, of which 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 (BCVA), as measured using the Early Treatment of Diabetic Retinopathy Study scale, from baseline at week 24, compared with 16% of patients who underwent a sham procedure.
The improvement, which was the primary endpoint of the trial, was statistically significant.
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 with 1.2 letters at week 4 and 2.9 letters at week 24 in the control arm, respectively.
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 located between the choroid and the outer protective layer of the eye known as the sclera.
In addition, 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 with a 19 micron mean reduction in the sham arm, a result that also was statistically significant.
Suprachoroidal CLS-TA was generally well tolerated, with no treatment-related serious adverse events reported in the trial.
Dr. Rahul Khurana, an investigator for PEACHTREE, said the study was the first pivotal Phase 3 clinical trial of a drug candidate for patients with uveitic macular edema in which a BCVA measure was the primary efficacy endpoint, potentially raising the bar for future trials in this population.
“I believe that based on these positive results, and if marketing authorization is obtained from the FDA, suprachoroidal CLS-TA has the potential to become a new paradigm for the treatment of visual impairment associated with macular edema associated with non-infectious uveitis,” he added.
Clearside president and CEO, Daniel White, said that having nearly 50% of the PEACHTREE trial patients treated with suprachoroidal CLS-TA gain 15 or more letters in vision is highly compelling.
“It represents a huge step forward in advancing suprachoroidal administration of CLS-TA towards becoming a powerful new approach in potentially treating blinding eye diseases,” he added.
The company currently expects to submit a NDA for suprachoroidal CLS-TA in patients with macular edema associated with uveitis to the FDA in the fourth quarter of 2018. Clearside also is evaluating a number of options for submissions to regulatory agencies outside of the U.S.
Suprachoroidal CLS-TA, used either alone or together with an intravitreal anti-VEGF agent, is being studied as part of Clearside’s pipeline of treatments for unmet or underserved blinding eye diseases where the pathologies manifest in the retina and the choroid.