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Q. What is a vitreous hemorrhage?
A. A vitreous hemorrhage is bleeding into the vitreous humor, the clear, gel-like substance that comprises the back of the eye, preventing light from reaching the retina. A mild vitreous hemorrhage may result in a patient being able to see only a few dark spots, while a severe hemorrhage may block out all vision, only permitting light perception.

Q. Who is at risk for a vitreous hemorrhage?
A. Based on research commission by ISTA in 1999, ISTA believes that approximately 450,000 cases of vitreous hemorrhage occur in the United States each year and over one million cases annually including Western Europe and Japan. While a vitreous hemorrhage may be caused by several underlying conditions or predispositions, including macular degeneration and various retinal diseases, or by trauma to the eye, a majority of vitreous hemorrhages occur as a result of a complication of diabetic retinopathy.

Q. What is diabetic retinopathy?
A. Diabetic retinopathy is a complication of diabetes. It is caused by changes in the blood vessels in the back of the eye. Diabetic retinopathy is the leading cause of adult blindness in the United States. Diabetic retinopathy is typically classified into two stages, non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR).

For additional information on NPDR and PDR, please visit the diabetic retinopathy section on this site's Conditions Page.

Q. What is corneal opacification?
A. Corneal opacification is a clouding or scarring of the normally transparent cornea that diminishes the amount of light entering the eye, impairing vision. Corneal opacification can occur as a result of bacterial, fungal or viral infections, or from trauma to the eye.

Q. What is keratoconus?
A. Keratoconus is a progressive disease of the eye in which the cornea becomes progressively thinner and the development of an irregular, cone-like corneal protrusion occurs. As the disease progresses, vision becomes increasingly distorted.

Q. Where do ISTA's product candidates fit into the ophthalmic industry and currently available eye care products?
A. With its various proprietary formulations of hyaluronidase, ISTA is developing drugs to address what we believe has largely been an ignored area of research and development in ophthalmology: non-surgical treatment of diseases of the eye for which there are currently only surgical treatments available. Invasive surgical procedures, including laser photocoagulation, phacoemulsification, corneal transplant and vitrectomy, account for many of the treatment options that are sole alternatives for individuals who are suffering from various eye conditions. By developing drugs to address what we believe are unmet medical needs, ISTA's efforts are focused on expanding the treatment options available to ophthalmologists and other eye care professionals within the field.

Q. What common thread runs through all of ISTA's current drug candidates?
A. Currently, ISTA is focusing its research and development efforts on products that incorporate the unique properties of a highly purified form of the enzyme hyaluronidase. Hyaluronidase is a group of naturally occurring enzymes that digest certain forms of carbohydrate molecules called proteoglycans. Proteoglycans such as hyaluronan, hyaluronic acid, and chondroitin sulphate serve as connective tissues in various parts of the body, including the eye. ISTA has identified several serious diseases and conditions of the eye in which the activity of specially purified and formulated hyaluronidase may result in significant improvements for the patient.

Each of ISTA's three current drug candidates contain a proprietary formulation of the enzyme hyaluronidase.

Q. What does it mean for a drug candidate to have fast-track designation?
A. A fast-track product is defined as a new drug or biologic intended for the treatment of a serious or life-threatening condition that demonstrates the potential to address unmet medical needs for the condition. The Food and Drug Administration Modernization Act of 1997 was enacted, in part, to ensure the availability of safe and effective drugs, biologics and medical devices by expediting the FDA review process for new products. The Modernization Act establishes a statutory program for the approval of fast- track products.

Q. When will Vitrase® be available to the public?
A. Vitrase® is already available in the U.S. as a spreading agent. It will only be available for vitreous® hemorrhage if and when the FDA approves the ISTA application for use in vitreous® hemorrhage conditions.

Q. What is ISTA's relationship with Allergan?
A. In 2004, ISTA entered into a new agreement with Allergan, Inc. replacing the previous Vitrase collaboration, and ISTA reacquired all rights to market and sell Vitrase for all uses in the United States and other specified markets. Allergan has an option to commercialize Vitrase in Europe subsequent to European Union, or EU, product approval. If Allergan does not exercise its option, then such European rights will revert to ISTA. Under this new agreement, ISTA does have the responsibility to file for regulatory approval for Vitrase for vitreous hemorrhage in the EU.

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