ALPHARETTA, Ga.–(BUSINESS WIRE)–Clearside Biomedical, Inc., a late-stage clinical biopharmaceutical
company developing innovative first-in-class drug therapies to treat
blinding diseases of the eye, today 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 (Eylea®, Regeneron Pharmaceuticals)
delivered intravitreally. Clearside expects to report top-line data from
this clinical trial in the first half of 2016.
“I am extremely pleased with the commitment of the participating
physicians and with our team who have contributed to our completing
enrollment of patients in the Tanzanite trial,” said Daniel H. White,
CEO and President of Clearside. “We believe SCS™ drug administration of
CLS-TA, in combination with a VEGF inhibitor, could reduce the frequency
of required RVO treatments from monthly to quarterly.”
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 we 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).
About Retinal Vein Occlusion
Retinal vein occlusion (RVO) is a sight-threatening disorder resulting
from the blockage of one of the veins carrying blood out of the retina.
RVO is estimated to affect more than 16 million adults worldwide,
according to a 2010 study published in the journal Ophthalmology,
and it is estimated that RVO affects 2.2 million adults in the United
States. In RVO, the blockage of a retinal vein can lead to poor blood
circulation, low oxygen and sometimes inflammation. A blocked vein will
leak its contents of blood and fluid. Bleeding within the retina and
swelling from the fluid can create macular edema.
About Clearside Biomedical, Inc.
Clearside Biomedical, Inc., headquartered in Alpharetta, GA, is a
late-stage clinical biopharmaceutical company developing innovative
first-in-class drug therapies to treat blinding diseases of the eye
using Clearside’s proprietary microinjector to reach diseased tissue
through the SCS™. Clearside holds intellectual property protecting the
delivery of drugs of any type through the SCS™ to reach the back of the
eye. Visit www.clearsidebio.com
for more information.