US green light for Merck & Co’s eye drug Zioptan
The US Food and Drug Administration has given the nod to Merck & Co’s eye solution Zioptan for lowering intraocular pressure in patients with certain eye conditions.
Shares in the drugmaker were given a bump after it announced that Zioptan (tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution, has been approved for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
According to the firm, the FDA’s approval came on the back of safety and efficacy results from five clinical studies in 905 patients, which showed that once-daily Zioptan lowered IOP at three and six months by 6-8 mmHg and 5-8 mmHg, respectively, from a baseline pressure of 23-26 mmHg.
The news will come as some relief as the drug was originally rejected in a complete response letter by US regulators late last year, but should now be available throughout the US in March, Merck said.
In 2009 Merck entered into global licensing agreement with Japan’s Santen Pharmaceutical Co for tafluprost, under which the US drugmaker gained exclusive commercial rights in Western Europe (excluding Germany), North America, South America, Africa, the Middle East, India and Australia.