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InSite Vision's AzaSite to Be Highlighted at ARVO Conference; Two Poster Presentations, Including a Second Anti-Infective Advisory Board Meeting.


ALAMEDA, Calif. -- InSite Vision Incorporated (AMEX AMEX

See: American Stock Exchange
:ISV (Independent Software Vendor) A person or company that develops software. It implies an organization that specializes in software only and is not part of a computer systems or hardware manufacturer. ) -- an ophthalmic therapeutics, diagnostics and drug delivery company -- today announced that work by its scientists and collaborators will be highlighted in formal presentations and poster presentations at the Association for Research in Vision and Ophthalmology (ARVO ARVO Association for Research in Vision and Ophthalmology. ) 2006 Annual Meeting being held in Fort Lauderdale, Florida Fort Lauderdale, known as the "Venice of America" due to its expansive and intricate canal system, is a city in Broward County, Florida, United States. The city's population is described as metropolitan, where diverse culture is commonplace. According to 2006 U.S. .

"We are truly delighted to have the opportunity to present further study results and clinical data on AzaSite(TM) at this prestigious medical conference," said S. Kumar Chandrasekaran, Ph.D., InSite Vision's Chief Executive Officer. "The presentations will also cover the results and quantitative analysis of the phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study.  of AzaSite versus tobramycin tobramycin /to·bra·my·cin/ (to?brah-mi´sin) an aminoglycoside antibiotic derived from a complex produced by Streptomyces tenebrarius, ."

"We have convened our second Anti-Infective Advisory Board Meeting to prepare for the market introduction of AzaSite, after the appropriate NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  submission and approval by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
. The composition of this advisory board includes eminent vision care specialists in ocular anti-infective diagnosis and treatment," said Chandrasekaran.

Formal presentations at ARVO include:

A Randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 Trial Assessing Microbial Eradication and Clinical Efficacy of 1% Azithromycin Ophthalmic Solution vs. Tobramycin in Adult Subjects With Bacterial Conjunctivitis conjunctivitis (kənjəngtəvī`təs), inflammation or infection of the mucosal membrane that covers the eyeball and lines the eyelid, usually acute, caused by a virus or, less often, by a bacillus, an allergic reaction, or an .

M. B. Abelson, (1)(2) E. E. Protzko, (3)(4) A. M. Shapiro, (1) AzaSite Clinical Study Group

(1) Ophthalmic Research Associates, North Andover, MA; (2) Schepens Eye Research Institute and Harvard Medical School Harvard Medical School (HMS) is one of the graduate schools of Harvard University. It is a prestigious American medical school located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts. , Boston, Massachusetts; (3) Seidenberg Protzko Eye Associates, Bel Air, Maryland Bel Air is the name of two places in the State of Maryland in the United States of America:
  • Bel Air, Allegany County, Maryland
  • Bel Air, Harford County, Maryland (This area has the postal designation of Bel Air, Maryland)
; (4)University of Maryland University of Maryland can refer to:
  • University of Maryland, College Park, a research-extensive and flagship university; when the term "University of Maryland" is used without any qualification, it generally refers to this school
 School of Medicine, Baltimore, Maryland.

The results of this phase 3 clinical trial show that the clinical resolution and bacterial eradication rates of AzaSite are equivalent to those of tobramycin even though AzaSite was dosed less frequently. Prominent organisms eradicated by both tobramycin and AzaSite were Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, and other viridans Streptococcus streptococcus (strĕp'təkŏk`əs), any of a group of gram-positive bacteria, genus Streptococcus, some of which cause disease. .

The results confirm that clinical resolution of bacterial conjunctivitis and eradication of bacterial species prevalent in acute bacterial conjunctivitis can be accomplished with a 5-day regimen of AzaSite 1.0% instilled bid on days 1 and 2 and qd on days 3 through 5. This regimen and reduced dosing frequency was just as effective as tobramycin dosed qid for 5 days.

A Randomized Trial Assessing Safety and Tolerability of 1% Azithromycin Ophthalmic Solution vs. Tobramycin in Adult and Pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 Subjects.

E. E. Protzko, (1)(2) M. Abelson,(3A)(4A) Shapiro, (3B) AzaSite Clinical Study Group.

(1) Ophthalmology, Seidenberg Protzko Eye Associate, Havre de Grace, Maryland Havre de Grace (HDG) is a city in Harford County, Maryland, United States. The population was 11,331 (17,221 if you include the greater Havre de Grace area) at the 2000 census. Havre de Grace is named after the port city of Le Havre, France. ; (2) Ophthalmology, University of Maryland School of Medicine, Baltimore, Maryland; (3) Ophthalmic Research Associates, North Andover, Massachusetts North Andover is a town in Essex County, Massachusetts, United States. The population was 27,202 at the 2000 census. History
North Andover was first settled in 1646 and was officially incorporated in 1855.
; (B) Ophthalmology, (3) Ophthalmic Research Associates, North Andover, Massachusetts; (4) Ophthalmology, Schepens Eye Research Institute and Harvard Medical School, Boston, Massachusetts.

We have demonstrated that AzaSite is efficacious at eradicating the bacteria that are predominately associated with bacterial conjunctivitis.

Moreover, our studies show that AzaSite is safe and well tolerated. Overall, no clinically relevant or statistically significant differences in adverse events were observed between the AzaSite and tobramycin groups. The safety of AzaSite in this population was excellent and similar to that seen with tobramycin. Treatment-emergent adverse events were reported in 15% to 20% of patients; one third of these events were judged not to be related to treatment and most were mild in severity. Additionally, there were no safety concerns based on changes in visual acuity, biomicroscopic, or ophthalmoscopic ophthalmoscopic

pertaining to the ophthalmoscope.


ophthalmoscopic examination
see ophthalmoscopy.
 measurements.

AzaSite is as safe and well tolerated in children and adults as tobramycin.

Research abstracts and additional presentation information are available on the ARVO website at www.arvo.org.

Founded in 1928, ARVO is an organization intended to encourage and assist research, training, publication and dissemination of knowledge in vision and ophthalmology. The current multidisciplinary membership of 10,800 individuals includes both clinical and basic researchers from around the world.

About InSite Vision Incorporated

InSite Vision is an ophthalmic company focused on developing therapies that treat ocular infections, glaucoma and retinal diseases. InSite Vision's lead product is AzaSite, which targets bacterial infections of the eye. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with DuraSite(R), InSite Vision's patented drug-delivery vehicle, which offers the benefit of a low-dosing regimen, attractive to both the eye-care patient and physician. Pending the filing and approval of an NDA with the FDA, InSite Vision currently expects AzaSite to be commercially launched in the United States, while seeking to expand this "technology platform" to include additional product candidates and indications for the worldwide market.

In the glaucoma area, InSite Vision continues to focus genomic research on the TIGR TIGR The Institute for Genomic Research
TIGR Treasury Investment Growth Receipt
TIGR This Is Getting Ridiculous
TIGR Thermally Induced Gallium Removal
TIGR TSPI Interface for GPS/RAJPO
 gene, among other genes in its genomic portfolio. A portion of this research has been incorporated into InSite Vision's commercially available OcuGene(R) glaucoma genetic test for disease management, which is a prognostic tool designed to detect a genetic marker (mt-1) in the promoter region of the glaucoma-related TIGR gene.

Additional information can be found at the Company's website, www.insitevision.com.

This news release contains, among other things, certain statements of a forward-looking nature relating to future events or the future business performance of InSite Vision, such as the timing of filing an NDA with the FDA, the Company's ability to obtain FDA approval of its NDA, the anticipated date of commercialization of AzaSite, and the Company's plans to present clinical trial results at the ARVO meeting. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision's ability to obtain additional financing, InSite Vision's ability to commence, complete and file an NDA with the U.S. FDA for AzaSite, and receive approval from the FDA for the commercialization of AzaSite; InSite Vision's ability to launch AzaSite and the timing of such a launch; InSite Vision's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, including those with respect to AzaSite and ISV-205; its reliance on third parties for the development, marketing and sale of its products; its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others, determinations by the FDA, including those with respect to OcuGene, AzaSite and ISV-205. Reference is made to the discussion under the caption "Risk Factors" and elsewhere 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. All forward looking statements in this press release and/or conference call are based on the limited information currently available to InSite Vision, which is subject to change. Although any such 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 and/or conference call is still valid at any later date.

Note to Editors: OcuGene(R) is written with a "small cap" G; if doing so is not possible, please use an upper case G. InSite Vision Incorporated, InSite Vision, DuraSite(R) and OcuGene(R) are trademarks of InSite Vision Incorporated. Other trademarks that may be mentioned in this release are the intellectual property of their respective owners.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:May 2, 2006
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