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FDA Panel Rejects Vitreous Hemorrhage Treatment

IRVINE, Calif., March 17 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (NASDAQ:ISTA) today announced that the U.S. Food & Drug Administration's Dermatologic and Ophthalmic Drug Advisory Committee voted 8 to 4 that the Company had not demonstrated sufficient statistical evidence to support the efficacy of Vitrase(R) (ovine hyaluronidase) in the treatment of vitreous hemorrhage. However, the panel also voted 7 to 5 that the benefits of using Vitrase could outweigh the risks of the drug in certain sub-groups of patients. The panel also recommended that ISTA provide additional analyses of the current data from the Company's two pivotal, Phase III clinical trials. Further, the panel and the FDA commended the Company for its pioneering work and recognized the difficulty in defining the endpoints in this challenging and serious disease.

Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA, commented, "We are disappointed with the panel vote regarding the statistical analyses of efficacy and feel that this may have resulted from some confusion concerning the use of multiple endpoints in the trials. Nonetheless, the majority of the panel recognized that the clinical benefits outweigh the safety risks, particularly in patients with limited treatment options. We look forward to continuing to work with the FDA to determine the appropriate next steps."

FDA advisory committees provide independent opinions and recommendations to the FDA on applications to market new drugs. Advisory committees consist of medical professionals, scientists and researchers who are recognized as experts in their fields, as well as industry leaders, consumer representatives and patient representatives. Marketing applications include data to show the safety and effectiveness of human drugs. The committees receive summary information about the applications and copies of the FDA's review of the application documents. Based on this information, advisory committees may recommend approval or disapproval on a drug's marketing application, or ask for additional information. Although committees provide recommendations to FDA, final decisions regarding a drug's marketing application are made by FDA. Further information on FDA advisory committees is available at www.accessdata.fda.gov.

ISTA's Vitrase is a proprietary formulation of highly purified ovine hyaluronidase, administered by injection into the vitreous of the eye. A vitreous hemorrhage occurs when blood collects in a patient's vitreous, the clear, gel-like substance that resides in the back of the eye. Several underlying medical conditions such as diabetes, macular degeneration and various retinal diseases may cause this condition. The majority of vitreous hemorrhages are attributable to complications relating to diabetes.

There is currently no drug treatment for vitreous hemorrhage. Initially, most patients are monitored during a "watchful waiting" period, to determine if the hemorrhage will clear on its own without treatment. If the hemorrhage does not clear, the current medical treatment for vitreous hemorrhage is vitrectomy, an invasive surgical procedure that may result in future cataract formation, retinal detachment or other complications. During a vitrectomy, a patient's vitreous humor is surgically removed. However, some patients are unable or unwilling to undergo vitrectomy.

ISTA initiated its clinical trial program under the assumption that an injection of Vitrase(R) would cause the vitreous to liquefy, thereby promoting the clearance of vision-distorting blood. Elimination of blood helps to restore vision and provides an ophthalmologist with an view of the retina, allowing the doctor to diagnose and treat the underlying cause of the hemorrhage.

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