Clearside Biomedical, Inc.
Clearside Biomedical, Inc., a clinical-stage biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye, today announced the efficacy and safety results from Clearside’s recently completed six-month Phase 1/2 clinical trial.
In the trial, eight patients with non-infectious uveitis at three U.S. centers received a single suprachoroidal injection of a commercially available formulation of triamcinolone acetonide (TA) using Clearside’s proprietary microinjector. All patients were evaluated for safety and tolerability, in addition to being monitored for changes in best corrected visual acuity (BCVA) and retinal thickness.
During the course of the trial, patients showed improvement in BCVA ranging between one and 5 lines (or up to 25 letters). BCVA is measured on an Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart in which a line of improvement corresponds to five letters of improvement. When measured at week 12, the average improvement in BCVA exceeded two lines of improvement while at week 26 the average was close to three lines of improvement.
At weeks 12 and 26 of the trial, the average reduction in retinal thickness, which is a common measure for macular edema, for patients, was greater than 100 microns from their respective baselines; this reduction is considered meaningful. Macular edema is the most frequent cause of visual impairment among patients with uveitis.
Debra Goldstein, MD, Professor of Ophthalmology and Director, Uveitis Service at the Northwestern University Feinberg School of Medicine, commented, “Delivery of drug to the suprachoroidal space may provide therapeutic effect close to the source of retinal and choroidal pathology, which may in turn have an impact on the dose required to achieve a benefit, as well as on the duration of effect.”
The suprachoroidal injection of TA was generally safe and well tolerated in this trial. No patient in the trial experienced any meaningful increase in intraocular pressure (IOP) at any time point following the suprachoroidal injection of TA; therefore, no patients were required to use IOP-lowering medications in the trial. Historically, treating ophthalmic conditions with steroids has shown adverse effects, like increases in intraocular pressure that may lead to glaucoma and lens opacification. Based on these data, Clearside believes that the suprachoroidal administration of steroid in the eye using their proprietary microinjector may avoid or reduce some of these side effects that are commonly seen when steroids are delivered via eye drops or intravitreal injection.