The Food and Drug Administration has sent a warning letter to Irvine-based eye drug maker Ista Pharmaceuticals Inc. about advertising for its flagship product.
Regulators said marketing material for Ista’s Xibrom drug for treating pain after cataract surgery overstates its effectiveness, minimizes risks and makes unsubstantiated claims of being better than rivals.
Wall Street has unfazed by the warning letter, which isn’t unsual for drug makers. Ista’s shares were up flat in midday New York trading on a market value of $130 million.
Xibrom accounts for 75% of Ista’s $110 million in yearly sales.
Regulators took issue with marketing material for the drug “because it suggests that Xibrom is superior to other drugs in its class when this has not been demonstrated by substantial evidence or substantial clinical experience.”
The letter also took issue with suggestions that Xibrom “is effective in a broader range of patients and conditions than has been demonstrated by substantial evidence or substantial clinical experience.”
Sales of Xibrom and other products led Ista to recently project its first full-year profit in its nearly 20-year existence.
Wall Street expects Ista to make $7.8 million this year before charges on sales of $148 million.
This year, the company expects expanded sales of Bepreve, a treatment for itchy eyes. Ista projects that Bepreve, which is sold through ophthalmologists, optometrists and allergists, could generate $20 million in sales this year.
