ISTA Pharmaceuticals Inc announced that the US Food & Drug Administration has approved the New Drug Application (NDA) for Istalmol, a once-a-day liquid formulation of timolol, for the treatment of glaucoma.
Thomas K Mundorf, an ophthalmologist and a clinical investigator for the US Istalmol clinical studies, commented, "Because glaucoma is a serious, chronic disease that must be treated for life, it is important to offer patients alternatives in their treatment regimen. Istalmol gives patients an effective, therapeutic option with the convenience of a once-daily formulation. I believe that this is an advance that patients and their caregivers will greatly appreciate."
Istalmol is ISTA's second product approved by the FDA. In May, ISTA announced FDA approval of ISTA's NDA for Vitrase (hyaluronidase for injection; lyophilized, ovine) for use as a spreading agent to facilitate the dispersion and absorption of other drugs.
Istalmol is a once-daily, topical solution of timolol, and a beta-blocking agent for the treatment of glaucoma.