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Preservative-free medications delivered from preserved multi-dose units to enhance surgical outcomes

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First Author: B.Dick GERMANY

Co Author(s):    A. Cummings                    

Abstract Details

Purpose:

Before surgery, many patients require chronic therapy to treat conditions such as dry eye or glaucoma. The use of preserved eye drops containing Benzalkonium chloride (BAK) results in ocular surface changes such as conjunctival hyperemia, superficial punctate keratitis or anterior blepharitis. There is an increasing number of reports on dissatisfactory outcomes after glaucoma surgery due to preservative-related inflammation and fibrotic changes. Three drop dosage forms are available: the preserved multi-dose form (drug and preservative), the preservative-free single dose unit and finally, the non-preserved multi-dose product (mechanical systems).

Setting:

University Eye Hospital Bochum, Germany

Methods:

The purpose of this trial is to investigate the delivery of preservative-free ophthalmic drugs from preserved multi-dose solutions. The dosage form consists of a bottle that contains the preserved drug solution and a customized hydrogel that is filled into the proprietary tip. When the bottle is squeezed, the drop is formed and passes through the hydrogel and the BAK is captured completely. Meanwhile, the drug passes through unchecked and is delivered sans preservative to the patient’s eye. Such a dosage form has been developed for several drugs (Timolol, Latanoprost and six other glaucoma medications).

Results:

In each case, simulated use studies over a 30-day period showed on-target delivery of the intended dose from preserved solutions while the BAK level in the drop was below the detection limit. Clinical studies over four weeks in 40 subjects with open-angle glaucoma or ocular hypertension showed that the BAK-free Timolol (product) was equally effective compared to marketed BAK-containing Timolol (control) as measured by trough IOP. At Day 7 and Day 28, the IOP reduction with Timolol delivered without BAK was non-inferior to the control group.

Conclusions:

This innovative platform technology provides for a convenient, affordable and safe solution for patients to keep the preservatives in the bottle. Thus, the use of this preservative-free medication delivered from preserved multi-dose units will likely result in fewer side effects, better adherence and provide better outcomes.

Financial Disclosure:

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