Clearside Biomedical, Inc. Announces Positive Preliminary Phase 2 Results in Patients With Macular Edema Associated with Retinal Vein Occlusion

Patients receiving a single treatment of ZUPRATA™ together with
EYLEA® qualified for 60% fewer additional EYLEA retreatments over a
3-month period (p=0.013)

Patients in the ZUPRATA + EYLEA arm achieved 19 letters of
improvement in Best Corrected Visual Acuity as compared to 11 letters of
improvement following EYLEA alone

ALPHARETTA, Ga.–(BUSINESS WIRE)–Clearside Biomedical, Inc. today announced that its Phase 2 clinical
trial evaluating concomitant administration of suprachoroidal ZUPRATA™,
Clearside’s proprietary form of triamcinolone acetonide, together with
intravitreal aflibercept (EYLEA®), for the treatment of macular edema
associated with retinal vein occlusion (RVO), achieved its primary
endpoint. In preliminary results from the trial, patients in the active
arm (those receiving concomitant administration of ZUPRATA and EYLEA)
qualified for approximately 60% fewer intravitreal EYLEA treatments than
those patients in the control arm who initially received EYLEA alone,
during the three-month observation period following initial treatment
(p=0.013). The trial, known as Tanzanite, is the first controlled,
masked, randomized clinical trial conducted in patients with RVO where
drug was administered through the suprachoroidal space.

Secondary endpoints in the trial included the mean change from baseline
in best corrected visual acuity (BCVA) and central subfield thickness.
For the BCVA endpoint, at month 1, patients in the active arm had an
average improvement of approximately 16 letters in BCVA, or over three
lines on a standard eye chart, compared to approximately 11 letters of
improvement, or just over two lines, for patients in the control arm,
each from their respective baseline measurements. At the end of the
three-month observation period, patients in the active arm had an
average improvement of approximately 19 letters, while patients in the
control arm maintained their same level of improvement at approximately
11 letters.

In the secondary objective of measuring the central subfield thickness,
at month 1, patients in both arms showed a mean reduction of over 400
µm. Patients in the active arm maintained this level of reduction
throughout the three-month trial, while patients in the control arm had
smaller levels of reduction as the trial progressed, with the mean
reduction declining to approximately 340 µm for patients in the control
arm beginning in month 2. In terms of safety results, there were no
serious adverse events reported in the trial, and the treatment was
generally well tolerated. Clearside plans on submitting the full data
set for presentation at an upcoming medical meeting.

“The preliminary data from this clinical trial continue to provide
support for the treatment of certain blinding eye diseases through
suprachoroidal space administration of ZUPRATA and the potential for an
effective and safe option for the treatment of RVO,” said Daniel H.
White, CEO and President of Clearside. “Based on these results,
Clearside intends to follow a 505(b)(2) NDA regulatory approval pathway
and expedite the preparations for a ZUPRATA Phase 3 registration program
for the treatment of macular edema associated with RVO.”

About RVO

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 in the eye. A blocked vein will leak
its contents of blood and fluid. Bleeding within the retina and swelling
from the fluid can result in 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 suprachoroidal space (SCS™) microinjector
to reach diseased tissue through the suprachoroidal space. Clearside
holds intellectual property protecting the delivery of drugs of any type
through the suprachoroidal space to reach the back of the eye. Clearside
has a portfolio of clinical and pre-clinical programs using drug
administration through the suprachoroidal space to provide a route of
access to treat diseases of the back-of-the-eye like RVO, uveitis,
neovascular age-related macular degeneration (wet AMD) and diabetic
macular edema (DME). Clearside is currently enrolling patients in a
Phase 3 clinical trial (Peachtree) for the treatment of patients with
macular edema associated with non-infectious uveitis and has initiated
IND-enabling studies for the treatment of wet AMD. Visit
for more information.


Clearside Biomedical, Inc.
Charles Deignan, 678-270-4005
Financial Officer
Trout Group
Matthew Beck, 646-378-2933