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InSite Vision Reports First Quarter 2007 Financial Results.


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 reported financial results for the three months ended March 31, 2007.

Net loss for the first quarter of 2007 was $2.6 million, or $0.03 per share, compared with a net loss of $5.3 million, or $0.06 per share, for the first quarter of 2006.

Research and development (R&D) expenses decreased to $1.9 million for the first quarter of 2007 compared with $3.1 million for the first quarter of 2006. The decrease was attributed to the completion of two AzaSite[TM] Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. , the second in the first quarter of 2006.

Selling, general and administrative (SG&A) expenses decreased to $1.5 million in the first quarter of 2007 from $1.7 million in the first quarter of 2006.

InSite Vision had cash and cash equivalents of $4.2 million at March 31, 2007, compared with cash and cash equivalents of $1.0 million at March 31, 2006. The increase is due to the $13 million license fee payment from Inspire Pharmaceuticals received in February 2007, and the subsequent repayment of $7.3 million of short-term debt Short-term debt

Debt obligations, recorded as current liabilities, requiring payment within the year.
 and accrued interest Accrued Interest

The interest that has accumulated on a bond since the last interest payment up to but not including the settlement date.

There are two methods for calculating accrued interest:
1) 360-day year method, used for corporate and municipal bonds.
.

S. Kumar Chandrasekaran, Ph.D., InSite Vision's chief executive officer, said, "We are excited about the level of activity so far in 2007. We believe that numerous events have begun to build a strong foundation for our future development. One of our recent successes, 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.
 approval of AzaSite, is a significant milestone for the Company, and triggered a $19.0 million milestone payment from our AzaSite commercialization partner, Inspire Pharmaceuticals. This payment is due May 11, 2007. We anticipate that AzaSite will be commercially launched in the late third quarter of 2007.

"Looking beyond AzaSite, we continue to solidify our foundation in the ophthalmic therapeutics market. Our next product in the pipeline, AzaSite Plus[TM], has completed Phase 1 clinical trials phase 1 clinical trial Phase 1 study. See Phase study. . We expect to pursue extended clinical trials in the near future," concluded Dr. Chandrasekaran.

Recent Company Developments

On April 30, 2007, InSite announced that the U.S. Food & Drug Administration (FDA) approved InSite's New Drug Application (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 ) for AzaSite (azithromycin 1% ophthalmic solution ophthalmic solution
n.
A sterile solution that is free from foreign particles and is compounded and dispensed for eyedrops.
) for the treatment of 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 . AzaSite is formulated with DuraSite, InSite Vision's patented drug delivery vehicle, which enhances the retention time of the antibiotic on the surface of the eye. InSite's clinical results demonstrated that AzaSite, administered twice per day for two days and then once per day for three days, 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 tobramycin /to·bra·my·cin/ (to?brah-mi´sin) an aminoglycoside antibiotic derived from a complex produced by Streptomyces tenebrarius,  administered four times a day for 5 days.

Under the licensing agreement with Inspire Pharmaceuticals, this approval automatically triggered the milestone payment of $19 million.

Conference Call

Kumar Chandrasekaran, PhD, Chief Executive Officer, and Sandra Heine, Vice President, Finance and Administration, will host a financial community conference call beginning at 4:30 p.m. EDT EDT
abbr.
Eastern Daylight Time


EDT Eastern Daylight Time

EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York

EDT 
 on Wednesday, May 9, 2007 to discuss these results.

Individuals interested in listening to the conference call may do so by dialing (877) 407-0778 for domestic callers and (201) 689-8565 for international callers. A telephone replay will be available for 48 hours following the conclusion of the call by dialing (877) 660-6853 for domestic callers and (201) 612-7415 for international callers. All callers will have to enter the account number 286 and conference ID 240928.

The live conference call will also be webcast and available on the Internet at www.InvestorCalendar.com as well as the Company's website at www.insitevision.com. A recording of the call will be available for 90 days following its completion of the conference call. In addition, this earnings release will be posted to the Company's web site and furnished to the Securities and Exchange Commission on a Form 8-K Form 8-K

The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock.


Form 8-K

See 8-K.
 prior to the conference call described above.

About InSite Vision Incorporated

InSite Vision is an ophthalmic company primarily focused on developing therapies that treat ocular infections, glaucoma glaucoma (glôkō`mə), ocular disorder characterized by pressure within the eyeball caused by an excessive amount of aqueous humor (the fluid substance filling the eyeball).  and retinal diseases. InSite Vision's lead product is AzaSite[TM], a topical anti-infective which targets infections of the eye, which was approved by the FDA in April 2007. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic The term broad-spectrum antibiotic refers to an antibiotic with activity against a wide range of disease-causing bacteria. This is in contrast to a narrow-spectrum antibiotic which is effective against only specific families of bacteria.  formulated with DuraSite, InSite Vision's patented drug-delivery vehicle, which offers the benefit of a low-dosing regimen which is attractive to both the eye-care patient and physician.

InSite Vision currently expects AzaSite to be commercially launched in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  in the late third quarter of 2007. Inspire Pharmaceuticals (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:ISPH ISPH Inspire Pharmaceuticals, Inc. ) has the responsibility to commercialize AzaSite in the U.S. and Canada in accordance with the parties' license agreement. InSite plans to pursue additional commercial partnerships during 2007 to address AzaSite market opportunities outside the U.S. and Canada.

The Company will continue to build on its azithromycin/DuraSite technology platform by developing AzaSite Plus as its follow-on to AzaSite. AzaSite Plus is an antibiotic and corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and  combination product, where the antibiotic inhibits ocular bacterial proliferation while the corticoseroid allows suppression of the inflammatory response.

Additional information can be found at our website, www.insitevision.com.

This news release contains certain statements of a forward-looking nature relating to future events, such as the timing of the anticipated commercialization of AzaSite, the expected benefits of AzaSite, the Company's plans to seek additional corporate collaborations to expand AzaSite outside the U.S. and Canada, the Company's clinical plans with respect to AzaSite Plus and build on its AzaSite technology platform. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision's ability to obtain substantial additional funding to continue its operations; the results of InSite Vision's clinical trials for AzaSite Plus and other product candidates; the ability of InSite Vision to enter into a corporate collaboration for AzaSite outside the U.S. and Canada and with respect to its other product candidates; the ability to commercially launch AzaSite and the timing and success of such a launch; InSite Vision's ability to expand its technology platform to include additional indications; the effects of its expense control activities on its operations and product development; its ability to obtain regulatory approval and market acceptance of its products and product candidates, including its OcuGene glaucoma genetic test, AzaSite, AzaSite Plus; InSite Vision's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, including those with respect to AzaSite; its reliance on third parties, including Inspire, for the development, marketing and sale of its products; the initiation and results of preclinical and clinical studies; and 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 Plus. 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 Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 and its quarterly reports on Form 10-Q Form 10-Q

See 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.

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.
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Publication:Business Wire
Article Type:Financial report
Date:May 9, 2007
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