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Company Overview
Company History and Transformation:

ISTA Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products.

The evolution of our company, from an early stage, single product company to a fully integrated, multi-product specialty pharmaceutical company is briefly described below.

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To learn more about the conditions that our products will treat, please click here.
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Stage I: Ovine Hyaluronidase for "front of eye" applications.

ISTA Pharmaceuticals was founded in 1992 as Advanced Corneal Systems. In its initial stage, the company's sole focus was the development of ovine hyaluronidase, a naturally occurring enzyme that digests certain forms of carbohydrate molecules called proteoglycans. The company first pursued the development of ovine hyaluronidase for various front of the eye (corneal) conditions, namely corneal opacification and keratoconus.

However, upon continual research and market assessment efforts, the company determined that a higher return could be realized through moving the ovine hyaluronidase development away from conditions in the front of the eye to conditions that are present in the back of the eye. Therefore, the company realigned its research priorities and began to pursue two higher potential indications, vitreous hemorrhage and diabetic retinopathy.

Because it was no longer focused solely on the front-of-the-eye conditions, the company changed its name to ISTA, the Lakota Sioux Indian word for the eye. This change more accurately reflected the direction of the company, that being its concentration on the health of the entire eye.

In addition, the company named its ovine hyaluronidase product, Vitrase®.

Stage II: Ovine Hyaluronidase for "back of eye" conditions.

The development of Vitrase® as a potential treatment for vitreous hemorrhage became the company's first back-of-the-eye priority. As such, the company completed three Phase II studies and two Phase III studies involving Vitrase® as a potential treatment for this condition. The Phase III studies were conducted in 14 countries and involved over 1,300 patients. In addition, the company completed a Phase II study evaluating Vitrase® as a potential treatment in the management of diabetic retinopathy as the first step toward pursuing this disease.

In September, 2002, ISTA completed and submitted the clinical section of the Vitrase® NDA for the vitreous hemorrhage indication. The FDA held an Advisory Panel in March, 2003 (see press release) and ISTA received an approvable letter from the FDA concerning the vitreous hemorrhage indication in April, 2003 (see press release). ISTA is currently working with the FDA on ways to resolve the issues contained in the approvable letter.

Stage III: Acquisition of 3 "late stage" ophthalmic products to broaden the Pipeline.

In May 2002, another major milestone was completed by ISTA when it acquired substantially all of the assets of AcSentient, Inc. The acquired assets included various rights to three "late stage" ophthalmic products, Istalol® , Xibrom™ and Caprogel®. As such, this acquisition immediately broadened ISTA's pipeline past a single product, Vitrase®.

Istalol® is a patent protected topical solution, once-a-day, non-selective beta-blocker for treating glaucoma . AcSentient previously acquired the rights to the compound from Senju Pharmaceutical Co., Ltd., a leading pharmaceutical company headquartered in Osaka, Japan . Senju submitted a NDA for Istalol® to the FDA in September 2002. The company received FDA approval of Istalol® in June 2004 and launched Istalol® in the United States in the third quarter of 2004.

Xibrom™ is a twice-a-day, topical, non-steroidal anti-inflammatory compound (NSAID) for the treatment of ocular inflammation. As with Istalol® , AcSentient previously acquired the rights to Xibrom™ from Senju Pharmaceutical Co., Ltd. ISTA initiated the US Phase III study for Xibrom™ in Q2 2003 and submitted the NDA to the FDA in May 2004. The FDA approved ISTA's NDA for Xibrom™ 0.09% for the treatment of ocular inflammation following cataract surgery in March 2005 ( see press release ). Xibrom™ is currently marketed for the treatment of ocular inflammation by Senju in Japan .

Caprogel® is a topical formulation of aminocaproic acid. Research completed at the Eastern Virginia School of Medicine (EVMS) has indicated that this product may be useful in the treatment of hyphema, or bleeding in the front of the eye. AcSentient previously acquired the rights to Caprogel® from EVMS.

In August 2003 ISTA filed a second NDA for Vitrase® (see press release). This NDA seeks approval for use of Vitrase® as adjuvant to increase the absorption of other injected drugs, for hypodermoclysis and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. FDA granted approval of this NDA in December 2004, and ISTA began marketing the product in January 2005. ISTA believes that the submission and FDA approval of this second NDA will allow Vitrase® to reach the market while the company continues to work with the FDA to resolve issues related to gaining the indication for vitreous hemorrhage.

Stage IV: Commercialization

In July 2004 ISTA launched its first product, Istalol®, and currently promotes it through a specialty sales force. ISTA launched its second product, Vitrase® for use as a spreading agent in January 2005. The company has hired regional sales managers, and has expanded it's sales force to support the commercial launch of Vitrase® for use as a spreading agent.

FDA approved the New Drug Application (NDA) for Xibrom ™ (bromfenac ophthalmic solution) 0.09% for the treatment of ocular inflammation following cataract surgery in March 2005. ISTA launched Xibrom ™, a topical, twice-daily, non-steroidal anti-inflammatory compound for the treatment of postoperative inflammation in patients who have undergone cataract surgery , during the second quarter of 2005, after securing commercial quantities of the product from its manufacturer and completing expansion of its sales force .

In addition, the company will continue to aggressive pursue the acquisition of late stage and/or currently marketed ophthalmic products that make strategic and financial sense.


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