Combination glaucoma drop moves toward approval

October 30, 2014

A preservative-free IOP-lowering eye drop that is a combination of tafluprost and timolol (Taptiqom, Santen) is seeking national licences in European countries after a positive decentralized procedure and a final assessment report from reference member state Germany, the Federal Institute for Drugs and Medical Devices of Germany, and agreement by concerned member states that the fixed-dose product is approvable.

A preservative-free IOP-lowering eye drop that is a combination of tafluprost and timolol (Taptiqom, Santen) is seeking national licences in European countries after a positive decentralized procedure and a final assessment report from reference member state Germany, the Federal Institute for Drugs and Medical Devices of Germany, and agreement by concerned member states that the fixed-dose product is approvable.

The drug, co-developed by Santen and Asahi Glass Co., comes in single-dose containers with 15 µg/mL of the prostaglandin tafluprost and 5 mg/mL of the beta blocker timolol. These two components lower IOP by complementary mechanisms of action, according to Santen, and the combined effect results in additional IOP reduction compared with either compound alone. The drop will be indicated for the reduction of IOP in adults who have open-angle glaucoma or ocular hypertension that has been insufficiently responsive to topical monotherapy.

Santen said it will work to make the drug available as soon as possible. For more detailed information on this news click here.