FDA warns ISTA on Vitrase ad

ISTA Pharmaceuticals received a letter from the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) concerning a journal advertisement for Vitrase, an adjuvant to increase the absorption and dispersion of other injected drugs. The DDMAC said the ad was misleading and did not mention the most common and serious side effects of taking the drug. The FDA demanded that ISTA retract the materials.

- read this press release [1] for the full FDA letter

ALSO: At the American Academy of Ophthalmology annual meeting, ISTA presented phase 3 data that indicates Vitrase significantly improves vision in patients with vitreous hemorrhage and eye disease for which there is no treatment. Article [2]