INSITE GETS PATENT ALLOWANCE FOR AZALIDE IN OCULAR INFECTION.

InSite Vision Incorporated (AMEX:ISV), Alameda, Calif., an ophthalmic therapeutics, diagnostics and drug-delivery company has received a notice of allowance from the U.S. Patent & Trademark Office for claims covering the use of azalide antibiotic formulations to topically treat ocular infections. InSite Vision uses azithromycin, an azalide, in ISV-401, the company's ocular antibiotic designed for the topical treatment of bacterial conjunctivitis.

ISV-401 combines azithromycin with DuraSite, the company's patented drug-delivery vehicle that offers the benefits of prolonged release of an active ingredient. In September 2002, the company reported positive safety and efficacy results from the ISV-401 Phase 2 study and last month announced FDA acceptance of InSite Vision's Phase 3 clinical trial protocol. InSite plans to initiate Phase 3 clinical trials in the second quarter of 2003.

"This allowance, combined with our previously issued patent on DuraSite/azalide formulations, creates a strong patent position for the ISV-401 program and any other azalide ophthalmic dosage form we may wish to pursue in the future," stated S. Kumar Chandrasekaran, Ph.D., InSite Vision's president and chief executive officer.

Azalide antibiotics are a class of macrolides effective against gram-positive and gram-negative bacteria with the additional property of having long biological half-lives. While azalides are currently dosed systemically, they have not previously been used in ophthalmology due partially to the difficulty of creating a stable aqueous formulation. InSite Vision used its drug delivery technology DuraSite to overcome the azalide stability issue. ISV-401 combines the long residence time attributable to DuraSite with the biological properties of the azithromycin to penetrate the eye tissues and form a reservoir, leading to significantly reduced dosing compared to currently marketed products.

InSite Vision is an ophthalmic products company focused on glaucoma, ocular infections and retinal diseases. In the area of glaucoma, the company conducts genomic research using TIGR and other genes. A portion of this research has been incorporated into the company's OcuGene(TM) glaucoma genetic test for disease management, as well as ISV-205, its novel glaucoma therapeutic. In December 2002, InSite Vision reached an agreement with SIFI S.p.A, a leading Italian ophthalmic pharmaceutical company, for them to be the exclusive manufacturer, distributor and promoter of OcuGene in Italy. ISV-205 uses InSite Vision's proprietary DuraSite drug-delivery technology, which also is incorporated into the ocular infection products ISV-401 and ISV-403, and InSite Vision's retinal disease program. Earlier this month, the company filed an IND with the U.S. Food & Drug Administration for ISV-403, which was licensed to Bausch & Lomb in August 2002.

For more information, visit http://www.insitevision.com or call 510/865-8800.