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February 12, 2016 1:18 AM ET

Pharmaceuticals

Company Overview of Clearside BioMedical, Inc.

Company Overview

Clearside Biomedical, Inc., a late-stage clinical biopharmaceutical company, develops first-in-class drug therapies to treat blinding diseases of the eye. Its product candidates include CLS-1001 that is in Phase III clinical trials for the treatment of macular edema associated with non-infectious uveitis; and CLS-1003, which is in Phase II clinical trials for the treatment of macular edema associated with retinal vein occlusion (RVO). The company also develops CLS-1002 program for the treatment of wet age-related macular degeneration (AMD). Clearside Biomedical, Inc. has a collaboration agreement with Santen Pharmaceutical Co., Ltd. to develop compounds for suprachoroidal space injection tha...

1220 Old Alpharetta Road

Suite 300

Alpharetta, GA 30005

United States

Founded in 2011

21 Employees

Phone:

678-270-3631

Fax:

678-270-4033

Key Executives for Clearside BioMedical, Inc.

Chief Executive Officer, President and Director
Age: 47
Chief Financial Officer
Age: 50
Executive Vice President of Research and Development
Age: 49
Vice President of Research and Development
Age: 49
Vice President of Scientific Affairs and Member of The Scientific Advisory Board
Compensation as of Fiscal Year 2015.

Clearside BioMedical, Inc. Key Developments

Clearside Seeks Acquisitions

Clearside BioMedical, Inc., launched the initial public offering of $57.5 million, net proceeds from the issuance, in the ordinary course of our business, expect to from time to time evaluate the acquisition, investment in or in-license of complementary products, technologies or businesses, and could use a portion of the net proceeds from this offering for such activities. Clearside BioMedical currently do not have any agreements, arrangements or commitments with respect to any potential acquisition, investment or license.

Clearside Biomedical, Inc. Announces Positive Topline Data from Phase 2 Clinical Trial for the Treatment of Macular Edema Associated with Non-Infectious Uveitis

Clearside Biomedical, Inc. announced positive results from the company’s Phase 2 clinical trial of CLS-TA, Clearside’s proprietary form of triamcinolone acetonide, using suprachoroidal space (SCS™) drug administration for the treatment of macular edema associated with non-infectious uveitis. The trial, referred to as the Dogwood trial, evaluated the safety and efficacy of CLS-TA in 22 patients with macular edema associated with non-infectious uveitis. In the trial, administration of CLS-TA resulted in a statistically significant mean change from baseline in central subfield thickness at eight weeks after one single treatment, which was the primary endpoint (p=0.0018). Statistical significance was also achieved in the mean increase from baseline in best-corrected visual acuity (p=0.0004), a secondary endpoint. There were no treatment-related serious adverse events reported in the trial, including no reported steroid-related increases in intraocular pressure (IOP), which is common in intravitreal and periocular drug delivery of corticosteroids. Clearside plans on submitting the full data set for presentation at an upcoming medical meeting. The data from this clinical trial continue to provide support for the approach to treatment of certain blinding eye diseases through SCS™ administration and the potential for an effective and safe option for the treatment of uveitis using CLS-TA, Clearside’s proprietary triamcinolone acetonide formulation. The Dogwood trial was the first masked, randomized clinical trial conducted in which drug was administered through the SCS™. This U.S., multi-center trial randomly assigned patients in a 4:1 ratio to receive a single injection of CLS-TA, 4 mg/100 µL or CLS-TA, 0.8 mg/100 µL. Subjects were treated at Day 1 and were monitored for safety and efficacy for eight weeks following their SCS™ injection.

Clearside Biomedical, Inc. Completes Enrollment in Phase 2 Clinical Trial of CLS-TA for the Treatment of Retinal Vein Occlusion Using Suprachoroidal Space Drug Administration

Clearside Biomedical, Inc. announced completion of enrollment in the company’s Phase 2 clinical trial (Tanzanite) for the treatment of macular edema associated with retinal vein occlusion (RVO). The trial uses CLS-TA, Clearside’s proprietary form of triamcinolone acetonide, injected by suprachoroidal space (SCS™) drug administration, concomitantly with aflibercept delivered intravitreally. Clearside expects to report top-line data from this clinical trial in the first half of 2016. The primary objective of the Tanzanite trial is to evaluate the safety and efficacy of a single SCS™ injection of CLS-TA together with an initial intravitreal injection of aflibercept, compared to the control group receiving only an intravitreal aflibercept injection. The primary efficacy endpoints in the trial include the number of patients in each arm eligible for additional aflibercept treatments, which believe will provide an indication of whether concomitant therapy reduces the number of required aflibercept treatments. Secondary endpoints of the trial include change in visual acuity and reductions in retinal thickness from baseline. Safety endpoints are the incidence of treatment-emergent adverse events and serious adverse events, including increases in intraocular pressure (IOP). Drug administration through the SCS™ potentially provides a route of access from the anterior region of the eye to treat diseases of the back-of-the-eye like RVO, uveitis, wet age-related macular edema (AMD) and diabetic macular edema (DME).

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