REPRINT FROM AUGUST 5, 2013
BioCentury
T H E BERNSTEIN REPORT O N BI OB USINESS
™
Article Reprint • Page 1 of 2
Emerging Company Profile
Clearside: Needle of the eye
By Emily Cukier-Meisner
Senior Writer
Clearside Biomedical Inc. is using
intraocular microneedles to deliver drugs
directly to the back of the eye less invasively
than intravitreal or subretinal injection.
The approach lets Clearside use less drug
than topical or periocular approaches and
reduce side effects by minimizing off-target drug exposure.
Current drugs for back-of-the-eye disorders are hindered by poor delivery.
Topical, periocular and systemic delivery
expose many non-target tissues to drugs.
So do invasive procedures such as ocular
implants and intravitreal injection, the
latter of which may cause vitreous hemorrhage, retinal detachment or endophthalmitis.
The Clearside technology, which was
developed at the Georgia Institute of
Technology and Emory University
School of Medicine, delivers drugs directly to the suprachoroidal space (SCS).
The SCS is a thin expandable region
posterior to the retina that sits between
the sclera and choroid layers of the eye.
Clearside’s microneedles are small enough
to insert perpendicularly through the sclera
to just reach the SCS without an incision
and without reaching other tissues.
Fluids injected by microneedle into the
BioCentury
®
SCS spread circumferentially as far as the
optic nerve, and drugs within them can
Clearside Biomedical Inc.
Alpharetta, Ga.
Technology: Ocular microinjection to
the retina and choroid through the
suprachoroidal space
Disease focus: Ophthalmic
Clinical status: Phase I/II
Founded: 2011 by Daniel White, Samir
Patel, Vladimir Zarnitsyn, Henry
Edelhauser and Mark Prausnitz
University collaborators: Georgia Institute of Technology and Emory University School of Medicine
Corporate partners: Santen Pharmaceutical Co. Ltd.
Number of employees: 18
Funds raised: $12 million
Investors: Hatteras Partners, Georgia
Research Alliance, Kenan Flagler Venture fund, Mountain Group Capital,
individual partners at Mountain Group,
Daniel White
CEO: Daniel White
Patents: 2 issued covering use of a
microneedle to deliver drug into the eye
DAVID FLORES
President & CEO
reach much higher concentrations in the
retina and choroid compared to other
ocular tissues.
“When a drug is injected into this
particular compartment, it will provide an
entirely different pharmacokinetic and
pharmacodynamic profile of a drug than
that of a drug given as an intravitreal
injection,” said President and CEO Daniel
White.
Clearside’s lead program is CLS1001,
a microneedle injection of triamcinolone
acetonide that is in Phase I/II to treat
uveitis.
Triamcinolone acetonide is approved
in intravitreal formulations to treat ocular conditions including sympathetic
ophthalmia, temporal arteritis, uveitis
and inflammatory conditions unresponsive to topical corticosteroids. However, its use is limited because it can
raise intraocular pressure (IOP) and produce cataracts.
White attributed these effects to activity in the vitreous humor and front of the
eye. He said in Clearside’s approach, most
of the injected drug is retained in the
choroid and retina — very little reaches
the anterior.
Data published in April in Investigational Ophthalmology and Visual Sciences
See next page
KAREN BERNSTEIN, Ph.D.
Chairman & Editor-in-Chief
T H E B ERNSTEIN R EPORT O N B I OB USINESS
PO Box 1246
San Carlos CA 94070-1246
Voice: 650-595-5333
Fax: 650-595-5589
www.biocentury.com
BioCentury®, The BioCentury 100, and The Clear Route are trademarks of BIOCENTURY PUBLICATIONS INC.
All contents © Copyright 2013, BIOCENTURY PUBLICATIONS INC. ALL RIGHTS RESERVED. No part of this
publication may be reproduced, photocopied or reproduced in any form, retransmitted, or stored in a
retrieval system without prior written consent of the publisher.
The contents of this publication are gathered from sources believed to be reliable, but in any case are
not warranted by the publisher for a particular use or purpose. Also, the content and opinions herein
may change without notice and do not constitute investment advice.
BioCentury,
THE BERNSTEIN REPORT
Needle of the Eye,
from previous page
showed suprachoroidal microneedle injection of 0.2 or 2 mg of triamcinolone
acetonide was as effective as 2 mg
intravitreal injection in reducing acute
inflammation in a porcine model, and
showed no evidence of toxicity or increased IOP.
Clearside previously conducted an
open-label study of Avastin bevacizumab
from Genentech Inc. and Roche in four
wet age-related macular degeneration
(AMD) patients in Mexico. It showed
the microneedle procedure was safe
and well tolerated, with no unexpected
or serious adverse events related to the
drug or injection, and no negative effect
on IOP.
White said Clearside is not developing
suprachoroidal Avastin at this time.
The company has enough funding to
complete both a Phase I/II trial of CLS1001,
ON
BIO BUSINESS
REPRINT FROM A UGUST 5, 2013
which is enrolling patients with non-infectious uveitis, and preclinical development
of an undisclosed steroid-sparing antiinflammatory agent for an undisclosed
indication.
White said Clearside plans to raise at
least $10 million in a series B round this
year to fund at least one Phase III trial of
CLS1001 in uveitis. The trial would begin
late this year or early in 2014 and would
support an NDA submission in late 2015
or early 2016.
He said Clearside intends to market
CLS1001 independently because the
ophthalmics field would not require an
expensive sales force, and because
Clearside’s management draws from former
executives of Novartis AG and its
ophthalmics businesses.
For example, VP of Commercial Operations Stephen Lang was SVP of U.S.
sales and marketing for the Novartis
ophthalmics unit.
Clearside is collaborating with strate-
P AGE 2 OF 2
gic investor Santen Pharmaceutical
Co. Ltd. on undisclosed retinal programs
unrelated to CLS1001 or the steroid-sparing agent.
Clearside CFO Charles Deignan said
the collaboration with the Japanese specialty pharma lets Clearside extend its
technology beyond known drugs without
composition of matter patents.
COMPANIES AND INSTITUTIONS MENTIONED
Clearside Biomedical Inc., Alpharetta, Ga.
Emory University School of Medicine,
Atlanta, Ga.
Genentech Inc., South San Francisco, Calif.
Georgia Institute of Technology, Atlanta,
Ga.
Novartis AG (NYSE:NVS; SIX:NOVN), Basel,
Switzerland
Roche (SIX:ROG; OTCQX:RHHBY), Basel,
Switzerland
Santen Pharmaceutical Co. Ltd. (Tokyo:
4536; Osaka:4536), Osaka, Japan