For the Treatment of Macular Edema Associated with Non-Infectious
ALPHARETTA, Ga.–(BUSINESS WIRE)–Clearside Biomedical, Inc., a clinical-stage 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 (Dogwood) of CLS-TA, Clearside’s
proprietary form of triamcinolone acetonide, using SCS™ drug
administration for the treatment of macular edema associated with
non-infectious uveitis. Clearside remains on track to report top-line
Phase 2 CLS-TA data by the end of 2015.
“I am exceedingly pleased with the efforts of the participating
physicians and with our team who contributed to our approach to the
treatment for uveitis. We are very excited to announce that we have
completed enrollment of the Dogwood trial,” said Daniel H. White, CEO
and President of Clearside. “We believe SCS™ drug administration of
multiple drugs like CLS-TA may provide superior outcomes for patients
suffering from chronic ophthalmic diseases like uveitis.”
The Dogwood trial is the first masked, randomized trial conducted in
humans administering drug through the suprachoroidal space. The primary
efficacy endpoint of the Dogwood Phase 2 clinical trial is the mean
change from baseline in retinal thickness at two months after treatment.
Secondary efficacy endpoints include visual acuity improvements at one-
and two-months after treatment, measured by the mean change in best
corrected visual acuity (BCVA) from baseline. Safety measures are being
monitored over the two-month observation period and include the
incidence of adverse events and serious adverse events, including
increases in 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 uveitis, retinal vein occlusion (RVO), wet
age-related macular edema (AMD) and diabetic macular edema (DME). In
June 2015, the company met with the U.S. Food and Drug Administration
(FDA) to review the ongoing clinical activities and discussed the
clinical strategy for CLS-TA using SCS™ drug administration for the
treatment of macular edema associated with non-infectious uveitis.
Agreement was reached with the FDA for the overall development plan with
a single pivotal Phase 3 clinical trial, and the company is planning to
enroll the first patient by December 2015.
Uveitis is inflammation inside
the eye, specifically affecting one or more of the three parts of the
eye that make up the uvea:
the iris (the
colored part of the eye); the ciliary body (behind the iris, responsible
for manufacturing the fluid inside the eye); and the choroid (the
vascular lining tissue underneath the retina).
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
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
clinical-stage biopharmaceutical company developing innovative
first-in-class drug therapies to treat blinding diseases of the eye.
Clearside’s product candidates focus on diseases affecting the retina
and the choroid, especially diseases associated with macular edema.
Clearside holds intellectual property protecting the delivery of drugs
of any type through the SCS to reach the delicate tissues of the choroid
and retina. Visit www.clearsidebio.com
for more information.
Clearside Biomedical, Inc.
Charles Deignan, 678-270-4005