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May 03, 2015 10:36 PM ET

Biotechnology

Company Overview of Clearside BioMedical, Inc.

Company Overview

Clearside BioMedical, Inc. offers research, development, and commercialization services for therapeutic products through an ocular microinjection platform that targets the individual compartments of the eye. It provides a non-surgical application for dosing drugs to distinct eye tissues, such as retina, trabecular meshwork, and corneal stroma. The company’s CLS1001 is under development for retinal applications through the delivery of therapeutics to the suprachoroidal space. Clearside BioMedical, Inc. was incorporated in 2011 and is based in Alpharetta, Georgia.

1220 Old Alpharetta Road

Suite 300

Alpharetta, GA 30005

United States

Founded in 2011

Phone:

678 270 3631

Fax:

678 270 4033

Key Executives for Clearside BioMedical, Inc.

Chief Executive Officer and President
Age: 46
Chief Financial Officer
Age: 49
Executive Vice President of Research and Development
Vice President of Research and Development
Age: 48
Director of Research
Compensation as of Fiscal Year 2014.

Clearside BioMedical, Inc. Key Developments

Spark Therapeutics, Inc. and Clearside Biomedical, Inc. Announce Exclusive Option to License Technology for Potentially Differentiated Delivery of Gene Therapy to the Eye

Spark Therapeutics, Inc. and Clearside Biomedical, Inc. announced that they have entered into an option agreement under which Spark acquired exclusive rights to license Clearside's microinjector technology to deliver gene therapies to the back of the eye. Under the agreement, the companies will explore the feasibility of using Clearside's microinjector technology to deliver viral vectors to the choroid and the retina through the suprachoroidal space (SCS). If Spark exercises its option, in return for exclusive, worldwide rights to use Clearside's microinjection technology and related intellectual property in the field of gene therapy, Spark will pay to Clearside an upfront licensing fee, development related milestones and commercial royalties on sales of Spark's products covered by the licensed technology.

Clearside BioMedical, Inc. Reports Efficacy and Safety Results in Non-Infectious Uveitis Using a Single Suprachoroidal Injection of Triamcinolone Acetonide

Clearside Biomedical, Inc. 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. 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.

Clearside Biomedical, Inc. Initiates Phase 2 Clinical Trial to Evaluate Reducing Treatment

Clearside Biomedical, Inc. announced the enrollment of the first patient in a Phase 2 randomized, controlled, masked, multi-center clinical trial for the treatment of macular edema associated with retinal vein occlusion (RVO) using Clearside's proprietary formulation of triamcinolone acetonide, CLS-TA, administered via suprachoroidal (SCS) injection using Clearsideâ s proprietary microinjector. Approximately 40 patients will be enrolled at 10 sites in the United States for the Phase 2 clinical trial. All patients will receive one intravitreal injection of Eylea and will be randomized on a 1:1 basis to receive a suprachoroidal injection of either CLS-TA or a sham procedure in the same visit. After randomization, patients will be seen in the clinic once per month for three months. Patients in either treatment arm will be evaluated at the subsequent visits one-, two- and three-months after the initial assigned treatment to receive additional intravitreal injections of Eylea, if they continue to experience macular edema or reductions in visual acuity. If they do not experience increases in macular edema or reductions in visual acuity at these subsequent visits, they will not receive additional intravitreal Eylea treatments. The primary objective of this study is to determine if a single suprachoroidal injection of CLS-TA administered along with an intravitreal injection of Eylea, compared to a single intravitreal injection of Eylea alone, will decrease the need for additional intravitreal Eylea treatments over three months.

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