BUSINESS WIRE
Successful FDA Meeting Informs Ongoing Late-Stage Clinical Program
ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (OTCBB: INSV) today reported that the company
recently met with the U.S. Food and Drug Administration (FDA or “the
Agency”) regarding the Phase 3 clinical program for ISV-502 (AzaSite
Plus™). ISV-502 is a topical combination antibiotic/corticosteroid
product formulated with InSite Vision’s patented DuraSite®
technology to enhance the retention time of the therapeutic agents on
the surface of the eye leading to increased ocular tissue concentrations.
Based on a review of the data from InSite’s initial Phase 3 clinical
trial, the Agency provided clear feedback on the late-stage development
plan for the possible New Drug Application (NDA) filing of ISV-502 for
the treatment of blepharitis (inflammation of the eyelid). Following
discussion with the FDA, InSite Vision will conduct a pilot study to
enable the revision of the Phase 3 protocol for pivotal clinical trials.
The pilot study will seek to demonstrate ISV-502’s ability to delay the
exacerbation and/or recurrence of acute episodes of blepharitis. InSite
Vision may seek another meeting with the FDA upon completion of the
pilot study to consider the final Phase 3 trial protocol. Additionally,
the FDA stated that it would be willing to consider a Special Protocol
Assessment (SPA) for ISV-502 prior to the start of the next Phase 3
clinical trial.
“We are pleased to have defined a clear path for the late-stage
development of ISV-502,” stated Kamran
Hosseini, M.D., Ph.D., Vice President, Clinical Affairs and Chief
Medical Officer for InSite Vision. “ISV-502 has demonstrated an ability
to improve clinical outcomes by reducing inflammation and eradicating
bacteria from the conjunctiva and eyelid. We believe that further
investigation will demonstrate that ISV-502 is more effective than an
antibiotic or corticosteroid alone in treating blepharitis.”
“Our meeting with the FDA has reaffirmed our commitment to the continued
development of ISV-502,” said Louis Drapeau, Chief Executive Officer of
InSite Vision. “Based on the FDA’s guidance, we intend to advance this
promising new ophthalmic product into late-stage development and will
seek a partner for the Phase 3 program and commercialization.”
In December 2008 InSite Vision completed a Phase 3 clinical trial of
ISV-502 in patients presenting with signs and symptoms of bacterial
infection and inflammation of the eye, including lid margin redness or
swelling, conjunctival redness or ocular discharge and lid irritation.
In the three-arm study, the anti-inflammatory and anti-microbial effects
of ISV-502 (a combination of 1% azithromycin and 0.1% dexamethasone)
were compared with either AzaSite® (azithromycin ophthalmic solution
1%), InSite’s topical antibiotic eye drop currently marketed for the
treatment of bacterial conjunctivitis, or dexamethasone, a commonly used
corticosteroid intended to address inflammation. ISV-502 improved
clinical outcomes as compared to treatment with a corticosteroid alone
or antibiotic alone in the reduction of inflammatory signs and symptoms
and bacterial eradication, respectively, but did not achieve statistical
significance in all arms of the trial. In addition, ISV-502 proved to be
very safe and it was very well tolerated. Based on these data, InSite
Vision requested the recently-held meeting with the FDA to review trial
results and discuss plans for further Phase 3 clinical evaluation.
About ISV-502 (AzaSite Plus) and DuraSite®
ISV-502 combines 1% azithromycin and 0.1% dexamethasone in InSite's
patented DuraSite® sustained delivery vehicle to provide simultaneous
antimicrobial and anti-inflammatory treatment for the treatment of
eyelid infection and inflammation in adults.
InSite’s DuraSite technology is a synthetic polymer-based formulation
designed to achieve increased retention time of the therapeutic agents
on the surface of the eye relative to conventional topical therapies
that are rapidly rinsed away by tears.
About Blepharitis
Blepharitis a frequent and recurring condition characterized by
inflammation of the eyelids, particularly the eyelid margins where the
eyelashes grow. It typically occurs as a result of a malfunction of the
oil glands at the base of the eyelashes leading to the growth of
bacteria. Blepharitis can be a chronic condition that is
difficult to treat. Current available approaches are limited in their
efficacy and may include eye hygiene practices, topical and/or systemic
antibiotics and topical corticosteroids.
About InSite Vision
InSite Vision is committed to advancing new and superior ophthalmologic
products for unmet eye care needs. InSite Vision is recognized for the
discovery and development of novel ocular pharmaceutical products based
on its DuraSite® bioadhesive polymer core technology, an innovative
platform that extends the duration of drug delivery on the eye’s
surface, thereby reducing frequency of treatment and improving the
efficacy of topically delivered drugs. The DuraSite platform is
currently leveraged in two products for the treatment of bacterial eye
infections, AzaSite® (azithromycin ophthalmic solution) 1% and
Besivance™ (besifloxacin ophthalmic suspension) 0.6%. AzaSite is
approved in the United States and Canada and currently marketed by
InSite Vision’s North American partner, Inspire Pharmaceuticals in the
United States. InSite Vision has formed multiple strategic licensing and
distribution agreements with qualified partners to market AzaSite in
select countries in Europe, Asia and South America upon regulatory
approval in those regions. Besivance was approved by the U.S. Food and
Drug Administration in 2009 and will be commercialized by Bausch & Lomb
and Pfizer Inc. in the second quarter of 2009.
InSite Vision’s ophthalmic product development portfolio also includes
ISV-502 and additional product candidates leveraging the company’s core
technologies. 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 the proposed indications and
clinical status of ISV-502 (AzaSite Plus), the potential benefits of
ISV-502, including as compared to other available treatments, InSite's
plans with respect to a future pilot study and future clinical trials
for ISV-502 and discussions with the FDA regarding the same, the FDA’s
consideration of a SPA with respect to ISV-502 prior to Phase 3 trials,
InSite’s plans to partner ISV-502, InSite's plans to advance its AzaSite
family of products, and InSite's corporate goals. Such statements entail
a number of risks and uncertainties, including but not limited to:
InSite's ability to commence additional clinical trials with respect to
ISV-502 and InSite's various other product candidates and the results of
such trials; the results of the planned pilot study on ISV-502, InSite’s
ability to work with the FDA to develop an appropriate Phase 3 protocol
for ISV-502, the clinical results of ISV-502, as well as InSite's other
product candidates; InSite's reliance on third parties for the
commercialization of ISV-502 and its other products; the ability of
InSite to enter into corporate collaborations for ISV-502 and with
respect to its other product candidates; InSite's ability to
successfully market ISV-502; InSite's ability to expand its technology
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, including those with respect to AzaSite and ISV-502;
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, including those with respect to ISV-502.
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.