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European regulators give positive opinion to glaucoma combo drug

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FORT WORTH, Texas — A European Union regulatory body has issued a positive opinion for a dual-therapy glaucoma drug.

The positive opinion, from the Committee for Medicinal Products for Human Use, sets the stage for marketing authorization for DuoTrav (travoprost 0.004%, timolol 0.5%, Alcon), the drug’s maker said in a press release.

One drop daily of DuoTrav “lowers IOP in two distinct ways by combining a beta blocker (timolol) to decrease the production of aqueous humor with a prostaglandin analogue (travoprost) to increase the outflow of aqueous humor,” the Alcon release said.

Alcon is seeking regulatory approval for the combination drug “to decrease IOP in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues,” the release said.

Regulatory approval is expected in the second quarter of the year, Alcon said. DuoTrav is already approved in Australia and is under regulatory review in countries outside the EU as well, the release said.