The U.S. Census Bureau projects that the population over the age of 65 will increase from 35 million in 1999 to approximately 70 million by the year 2030. We believe that this aging of the U.S. population, and similar trends in other developed countries, will contribute to increased demand for additional options in ophthalmic products.
InSite Vision's business strategy is focused on accelerating ophthalmic product opportunities that are consistent with our core competencies and allow us to address expanding needs in growing markets. We are addressing these opportunities in a variety of ways:
- Developing and extending our AzaSite® franchise in North America and abroad: We are committed to global development and commercialization of our AzaSite franchise product line (AzaSite®, AzaSite Xtra™, and AzaSite Plus™), and thus bringing our anti-infective therapies to more patients worldwide. AzaSite is currently approved in the United States and Canada, and was launched in the U.S. in August 2007 and is marketed by our North American commercial partner Inspire Pharmaceuticals, a wholly owned subsidiary of Merck & Co., Inc. (NYSE: MRK).
- Advancing our late stage pipeline toward NDA filings: Our portfolio of late stage (Phase 3) clinical ophthalmology products includes AzaSite Plus (ISV-502), DexaSite™ (ISV-305) and our bromfenac in DuraSite candidate: BromSite™(ISV-303). We intend to advance each of these Phase 3 candidates into and through Phase 3 trials and report the results by end-2012.
- Advancing our earlier stage pipeline toward Phase 3 clinical trials: Our portfolio of early late stage (Phase 1/2) clinical ophthalmology products includes ISV-101, our bromfenac in DuraSite™ candidate we are pursuing for the treatment of dry eye disease. We also intend to advance ISV-101 into and through Phase 1/2 trials and report the results by end-2012.
- Advancing our late pre-clinical pipeline toward Phase 1/2 clinical trials: AzaSite Xtra (ISV-405) is a higher dose (2.0%) of azithromycin ophthalmic solution formulated in DuraSite. InSite Vision has completed all formulation/stability data and all GLP toxicology work to support global IND and/or IND-equivalent filings. AzaSite Xtra will be pursuing a once-daily, three day dosing regimen for the treatment of ocular infections, such as blepharitis, blepharoconjunctivitis, or bacterial conjunctivitis (pink eye).
- Advancing our early pre-clinical pipeline toward IND-enabling GLP toxicology studies: We have completed preliminary formulation and stability work on three novel and promising ophthalmic solutions formulated in DuraSite (ISV-102, ISV-620, and ISV-215), and we are evaluating selecting our next candidate for formal GLP toxicology studies to support global IND and/or IND-equivalent filings.
- Seeking promising new late-stage products and technologies for in-licensing or acquisition: Applying our expertise in ophthalmology and leveraging revenue from our commercial partnerships, we are actively working to identify, in-license or acquire promising new product candidates to fuel and complement our R&D pipeline.
- Executing on plan with operational discipline: Implementation of our strategy will be guided by milestone-driven decision making and the careful management of resources. We will routinely evaluate expenses and seek means by which we can enhance operating efficiencies.