Merck’s eye drug Zioptan gains FDA approval
pharmafile | February 14, 2012 | News story | Sales and Marketing | Merck, Pfizer, Xalatan, Zioptan
The FDA has approved Merck’s eye solution Zioptan to treat a common eye condition.
Zioptan (tafluprost ophthalmic solution) can now be used in the US to help reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Open-angle glaucoma is the most common form of glaucoma, while ocular hypertension is a condition characterised by an increase in pressure inside the eye.
This drug is the first preservative-free prostaglandin analogue ophthalmic solution approved for this condition.
The approval was based on two Phase III clinical trials that showed Zioptan once-daily, lowered intraocular pressure at three and six months.
Zioptan has not had an easy route to approval in the US after the FDA sent Merck a complete response letter in November asking for more information about the new drug application, delaying its approval until today.
David Michelson, vice president, neurology and ophthalmic therapeutic area at Merck, said: “We are excited to continue Merck’s 50-year tradition of bringing forward additional options to help meet the needs of eye care professionals and their patients.”
The drug has already been approved for use in certain European countries under the brand Saflutan.
Merck also has older drugs designed to reduce intraocular pressure, Trusopt and Cosopt, but they have lost market exclusivity in the US and other countries.
Merck expects Zioptan to become available to patients next month, and will be priced at $97 for a 30-day supply.
But the drug will have to compete with generics after Pfizer’s Xalatan eye solution lost its patent protection in the US last March.
Xalatan (latanoprost ophthalmic solution), which is also indicated for the same licence as Zioptan, made $1.75 billion in 2010 before losing its patent protection in the US and other countries last year.
Ben Adams
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