InSite Vision Receives Regulatory Approval for AzaSite® in Canada
2009年3月31日 - 9:15PM
ビジãƒã‚¹ãƒ¯ã‚¤ãƒ¤ï¼ˆè‹±èªžï¼‰
InSite Vision Incorporated (AMEX:ISV) today announced that the
Therapeutic Products Directorate (TPD) of Health Canada has
approved the company�s new drug submission (NDS) for AzaSite
(azithromycin ophthalmic solution) 1% for the treatment of
bacterial conjunctivitis (pink eye) in adults and children one year
and older. AzaSite is formulated with DuraSite�, InSite Vision�s
patented drug delivery vehicle that enhances the retention time of
the antibiotic on the surface of the eye, offering the benefit of a
less frequent and more convenient dosing regimen.
AzaSite was approved for treatment of bacterial conjunctivitis
by the U.S. Food and Drug Administration (FDA) in April 2007, and
commercially launched in August 2007 by Inspire Pharmaceuticals, a
biopharmaceutical company based in Durham, North Carolina and
exclusive licensee of AzaSite in the U.S. and Canada. Under the
terms of the companies� agreement, the NDS will transfer to Inspire
Pharmaceuticals and Inspire will be responsible for marketing
AzaSite in Canada.
�Canadian approval of AzaSite is an important milestone for
InSite, furthering our efforts to reach more patients with a
product that is a clinically proven, safe and effective treatment
for conjunctivitis and typically requires less than half the dosing
of other ocular antibiotics,� commented Lou Drapeau, InSite�s Chief
Executive Officer. �We are focused on supporting our marketing
partner, Inspire Pharmaceuticals, on the expansion of AzaSite sales
and we look forward to working closely with them to capture
additional value for the product throughout North America.�
Canadian regulatory approval was based on two Phase 3 clinical
trials of AzaSite which demonstrated that AzaSite was safe and
effective. Enrolling more than 1400 patients with bacterial
conjunctivitis in the U.S. and Latin America, AzaSite was
administered twice daily on the first two days, then once daily on
days 3-5. Results from the Phase 3 pivotal trials demonstrated that
AzaSite provided clinically and statistically significant
improvements in clinical resolution of symptoms and bacterial
eradication compared to placebo; and was equivalent in clinical
resolution and bacterial eradication when compared to tobramycin
administered four times a day for five days.
About Conjunctivitis
Conjunctivitis (pink eye) is an inflammation or infection of the
transparent membrane (conjunctiva) lining the eyelid and part of
the eyeball. The cause is a bacterial or viral infection and the
most common symptoms include redness, itching or a gritty feeling
in one or both eyes, and may be accompanied by a discharge or
tearing. While anyone can get conjunctivitis, it is very common in
children, is highly contagious and has been estimated to account
for up to three million missed school days in the United States
alone.
About InSite Vision
InSite Vision is committed to advancing new and superior
ophthalmic products for unmet eye care needs. InSite 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.
By formulating the well-established antibiotic azithromycin in
DuraSite, InSite developed the lowest-dosing ocular antibiotic
available to the United States ophthalmic market, AzaSite�
(azithromycin ophthalmic solution) 1%. AzaSite is marketed by
Inspire Pharmaceuticals in the United States for the treatment of
bacterial conjunctivitis (pink eye) and will be by international
partners in South Korea, four countries in South America, Turkey
and China.
InSite�s ophthalmic product development portfolio also includes
ISV-502, which is currently in Phase 3 pivotal trials for the
treatment of eye and eyelid infection and inflammation
(blepharoconjunctivitis), 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
expected marketing of AzaSite Canada by Inspire and InSite�s plans
to advance AzaSite and its AzaSite family of products. Such
statements entail a number of risks and uncertainties, including
but not limited to: InSite�s reliance on third parties, including
Inspire, for the commercialization of AzaSite and its other
products; InSite�s ability to retain Mr. Drapeau and other key
management now and in the future; the ability of InSite to enter
into corporate collaborations for AzaSite outside its currently
licensed territories, and with respect to its other product
candidates, including ISV-502; Inspire�s ability to successfully
market AzaSite in the United States and Canada; the ability of
InSite�s international partners to obtain approval to market
AzaSite outside the U.S. and Canada; InSite�s ability to commence
clinical trials with respect to its various product candidates and
the results of such trials; the clinical results of InSite�s
product candidates; 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; 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.
Insite Vision (AMEX:ISV)
éŽåŽ» æ ªä¾¡ãƒãƒ£ãƒ¼ãƒˆ
ã‹ã‚‰ 5 2024 ã¾ã§ 6 2024
Insite Vision (AMEX:ISV)
éŽåŽ» æ ªä¾¡ãƒãƒ£ãƒ¼ãƒˆ
ã‹ã‚‰ 6 2023 ã¾ã§ 6 2024