Clinical Trial Achieves Statistical Significance on Primary Efficacy
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 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
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,” said Daniel H. White, CEO and
President of Clearside.
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 has a portfolio of clinical and pre-clinical
programs using drug administration through the SCS™ to provide a route
of access to treat diseases of the back-of-the-eye like uveitis, retinal
vein occlusion (RVO), wet age-related macular degeneration (AMD) and
diabetic macular edema (DME). Clearside has enrolled its first patients
in a Phase 3 clinical trial (Peachtree) for the treatment of patients
with macular edema associated with non-infectious uveitis; completed
enrollment of a Phase 2 clinical trial (Tanzanite) assessing the
efficacy and safety of CLS-TA used concomitantly with an intravitreal
injection of a VEGF inhibitor in patients with macular edema associated
with RVO; and initiated IND-enabling studies for the treatment of AMD.
Uveitis is inflammation inside
the eye and is classified anatomically as anterior, intermediate,
posterior or pan-uveitis, according to the primary site of inflammation.
Each of these categories, however, encompasses a number of conditions
that can be characterized further along other dimensions including:
onset, duration, course and etiology. Uveitis is one of the most
frequent causes of blindness in the developed world. Based on prevalence
data published in the journal Ophthalmology in 2004 and United
States census data for 2010, it is estimated that approximately 350,000
individuals in the United States suffer from some form of uveitis.
Typically diagnosed in individuals between the ages of 20 and 50,
uveitis can occur in one or both eyes and accounts for approximately 10%
of cases of blindness in the United States, according to a study
published in Journal of Ophthalmology. Uveitis can be either
infectious or non-infectious. Non-infectious uveitis accounts for
approximately 80% of all uveitis cases. Macular edema related to uveitis
is the predominant cause of blindness or visual impairment among
patients with uveitis, accounting for approximately 30% of cases of
blindness in uveitis patients. Because uveitis can become chronic or
recurrent if not adequately treated, some patients may become
refractory, or unresponsive, to treatment, leading to irreversible
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 SCS™ 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.