Under the agreement, ISTA will pay Senju an upfront payment and aggregate development and approval milestones of approximately $8 million for each product, in addition to royalties on future product sales.
ISTA will be responsible for North American development of both product candidates, including clinical trials and the preparation and submission of the New Drug Applications to the FDA. In addition, the company will be responsible for manufacturing and if FDA approved, marketing and selling of the products.
In early studies, iganidipine showed the ability to enhance ocular blood flow, lower IOP, and inhibit the progression of visual field defects. ISTA hopes to initiate a phase II clinical study in 2007 in the United States.
Prostaglandin analogues represent the largest segment of the U.S. glaucoma market. ISTA hopes to complete formulation development and optimization studies of latanoprost in 2007.
If the drugs are approved, then they will complement ISTA's timolol (Istalol), a once-daily beta blocker for glaucoma.