Clearside Biomedical raised $14.4 million in a new round of equity financing, and said yesterday it enrolled the 1st patient in the Phase 3 Peachtree clinical trial of its CLS-TA for treating patients with macular edema associated with non-infectious uveitis.
Clearside is developing CLS-TA triamcinolone acetonide to be delivered using its proprietary SCS microinjector for patients with macular edema. The device is designed to inject the compound in the suprachoroidal space, a gap no wider than 30 µm between the choroid and the sclera that extends from the anterior portion of the eye to the posterior near the optic nerve.
The company looks to raise another $5.6 million to bring in $20 million for the round. The funds raised so far have come from 9 anonymous sources, according to an SEC filing
The Peachtree trial of the company’s drug-device combo is a randomized, masked, sham-controlled trial to analyze the drug administered via the SCS injection in subjects with macular edema associated with non-infectious uveitis. Patients will receive either 2 unilateral SCS injections of CLS-TA or sham procedures approximately 12 weeks apart, the company said.
“The enrollment of our 1st patient and the advancement of CLS-TA into a pivotal trial for uveitis is a milestone for our organization and puts Clearside on a potential course to file our first NDA in 2017. We now have enrolled more than 70 patients in five clinical trials using SCS drug administration studying potential treatments for blinding conditions like uveitis, retinal vein occlusion (RVO), wet age-related macular degeneration (AMD) and diabetic macular edema (DME),” CEO Daniel White said in prepared remarks.
The clinical endpoint for the trial is the percentage of patients with a change of at least 15 letters in best corrected visual acuity, measured using the Early Treatment of Diabetic Retinopathy Study scale after 24 weeks.