The next few months will be important for Clearside Biomedical, one of the companies pioneering drug delivery to the suprachoroidal space.
The company expects by the end of this month to receive topline data from its Phase II Dogwood trial that is evaluating safety and efficacy of CLS-TA in macular edema associated with non-infectious uveitis.
By the close of Q1 2016, Clearside also projects to have topline results from its Phase II multi-center Tanzanite trial for a treatment of macular edema associated with RVO. The trial will compare combined treatment of CLS-TA and intravitreal Eylea (aflibercept, Regeneron) with an intravitreal injection of Eylea alone. Forty-four patients have been enrolled, and topline results are expected in the first quarter of 2016, said Stephen H. Lang, Vice President, Commercial Operations.
The company banked on the promise of the clinical trials to raise $20 million in new capital from new investors Aju IB Investment, Cormorant Asset Management, Perceptive Advisors and Rock Springs Capital Management, along with existing Clearside investors. Trout Capital LLC served as an advisor to Clearside.
The company announced enrollment of the first patient in its Phase III clinical trial using its proprietary drug delivery system using the targeting the suprachoroidal space to inject triamcinolone acetonide for treatment of macular edema associated with non-infectious uveitis.
Clearside has developed the SCS Microinjector that delivers drugs to the suprachoroidal space, which is no wider than 30 µm, as a potential access route to treat diseases like uveitis, retinal vein occlusion (RVO), wet age-related macular degeneration (AMD) and diabetic macular edema.
The Phase III uveitis trial, known as Peachtree, is a randomized, masked, sham-controlled trial to assess the efficacy and safety of 4 mg of CLS-TA, Clearside’s proprietary form of triamcinolone acetonide. Patients will be randomized to receive two unilateral SCS Microinjector injections of CLS-TA or two unilateral sham procedures approximately 12 weeks apart.
The clinical endpoint in the trial is the proportion of patients with a change in baseline of at least 15 letters in best-corrected visual acuity at 24 weeks, along with several safety endpoints. Clearside anticipates total enrollment of approximately 150 patients in the two-arm, six-month efficacy trial, across approximately 50 clinical sites.