InSite Vision Incorporated
ALAMEDA, Calif.--(BUSINESS WIRE)--Jul. 31, 2012--
InSite Vision Incorporated (OTCBB: INSV) today announced that patient
enrollment has begun in the first Phase 3 clinical trial of BromSite™
(ISV-303) for the reduction of pain and inflammation after cataract
surgery. This study will seek to enroll approximately 240 patients
undergoing cataract surgery in a two-arm trial designed to evaluate the
efficacy and safety of BromSite against the DuraSite vehicle alone.
BromSite combines a low dose (0.075%) of the non-steroidal
anti-inflammatory drug (NSAID) bromfenac with InSite Vision’s DuraSite
drug delivery technology.
“BromSite has the potential to significantly improve care for patients
undergoing cataract surgery in the rapidly growing eye surgery market,”
said Kamran Hosseini, M.D., Ph.D., Vice President and Chief Medical
Officer of InSite Vision. “We are confident this Phase 3 study will
enroll quickly given the positive data obtained in our prior clinical
trials of BromSite, including the statistically significant reduction in
pain and inflammation achieved in our Phase 1/2 study with the same
primary endpoint as this trial. We anticipate top-line results from this
first Phase 3 study will be available in late 2012 or early 2013.”
About the BromSite Phase 3 Study
The BromSite Phase 3 clinical study is a two-arm, double-blind,
placebo-controlled clinical trial where the placebo arm will be the
DuraSite vehicle. Using 15 separate sites, patients undergoing cataract
surgery will be randomized and then dosed twice-a-day beginning the day
before surgery and continuing the day of surgery and 14 days
post-surgery. The primary study endpoint is the reduction of pain and
inflammation after surgery. Pharm-Olam International has been selected
to serve as the contract research organization managing the BromSite
study on behalf of InSite Vision.
This is the first of two Phase 3 clinical studies in support of
BromSite’s regulatory submissions. In the second quarter of 2012, InSite
conducted an end-of-Phase 2 meeting with the U.S. Food and Drug
Administration (FDA) and two European regulatory meetings, where both
BromSite pivotal trials were discussed. The design of the second Phase 3
study for BromSite will soon be finalized pending full input from both
the European regulators and the FDA.
In the Phase 1/2 study of 169 patients undergoing cataract surgery,
once-daily and twice-daily doses of BromSite were compared against the
DuraSite vehicle alone. Once-a-day BromSite was demonstrated to be
superior to vehicle (53.3% versus 19.0%, P-value of 0.0016) in reducing
pain and inflammation. InSite reported results from the Phase 1/2
clinical study in March 2011. In a Phase 2 clinical study evaluating
pharmacokinetics, BromSite achieved more than twice the eye tissue
penetration than Bromday™ (bronfenac ophthalmic solution)
0.09% marketed by ISTA Pharmaceuticals. Results from the Phase 2
clinical trial comparing BromSite to Bromday were released in October
2011.
Cataract surgery is the most frequently performed ocular surgery in the
United States with more than three million procedures annually. Both
before and after surgery, anti-inflammatory eye drops are prescribed to
reduce pain and inflammation. Anti-inflammatory eye drops are also
administered as prophylaxis against cystoid macular edema, or CME. CME
is a relatively rare but extremely serious adverse event in ocular
surgery that can lead to blindness. Most physicians believe that a
higher penetration of bromfenac into the ocular tissues may reduce the
risk of CME. InSite intends to do additional clinical studies
post-approval in pursuit of adding prevention of CME to the BromSite
label.
About DuraSite
InSite's DuraSite sustained delivery technology is a synthetic
polymer-based formulation designed to extend the residence time of a
drug relative to conventional topical therapies. It enables topical
delivery of a solution, gel or suspension and can be customized for
delivering a wide variety of potential drug candidates. The DuraSite
platform is currently leveraged in two commercial products for the
treatment of bacterial eye infections, AzaSite® and Besivance®.
InSite Vision is advancing a portfolio of novel preclinical- to
clinical-stage ophthalmic products based on the DuraSite platform.
About InSite Vision
InSite Vision is advancing new ophthalmologic products for unmet eye
care needs. The company’s product portfolio utilizes InSite Vision’s
proven DuraSite® bioadhesive polymer core technology, an
innovative platform that extends the duration of drug retention on the
surface of the eye, thereby reducing frequency of treatment and
improving the efficacy of topically delivered drugs. The DuraSite
platform is currently leveraged in two commercial products for the
treatment of bacterial eye infections, AzaSite® (azithromycin
ophthalmic solution) 1%, marketed in the U.S. by Merck, and Besivance®
(besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb.
InSite Vision’s clinical-stage ophthalmic product pipeline includes
AzaSite Plus™ and DexaSite™ for the treatment of
eye infections, BromSite™ for pain and inflammation
associated with ocular surgery, and ISV-101 for the treatment of dry eye
disease. For further information on InSite Vision, please visit www.insitevision.com.
Forward-looking Statements
This news release contains certain statements of a forward looking
nature relating to future events, including InSite's planned Phase 3
trial for BromSite, the design, timing and potential outcome of same,
and the expected benefits of the BromSite product. Such statements
entail a number of risks and uncertainties, including but not limited
to: the timing of full enrollment of the Phase 3 trials, the results of
clinical trials for BromSite and the timing thereof, InSite’s ability to
obtain FDA approval of BromSite and the timing thereof; InSite's
reliance on third parties for the commercialization of its products; the
ability of InSite to enter into corporate collaborations for its product
candidates; InSite's ability to expand its product platform to include
additional indications; InSite's ability to compete effectively, either
alone or through its partners, with other companies offering competing
products or treatments; InSite's ability to maintain and develop
additional collaborations and commercial agreements with corporate
partners, its ability to adequately protect its intellectual property
and to be free to operate with regard to the intellectual property of
others; and determinations by the FDA. Reference is made to the
discussion of these and other risk factors detailed in InSite Vision's
filings with the Securities and Exchange Commission, including its
annual report on Form 10-K and its quarterly reports on Form 10-Q, under
the caption "Risk Factors" and elsewhere in such reports. Any
forward-looking statements or projections are based on the limited
information currently available to InSite Vision, which is subject to
change. Although any such forward-looking statements or projections and
the factors influencing them will likely change, InSite Vision
undertakes no obligation to update the information. Such information
speaks only as of the date of its release. Actual events or results
could differ materially and one should not assume that the information
provided in this release is still valid at any later date.
AzaSite® and DuraSite® are registered trademarks
of InSite Vision Incorporated.
BESIVANCE® is a
registered trademark of Bausch & Lomb Incorporated.