Unoprostone useful adjunct to maximal medical therapy

By Cheryl Guttman

Philadelphia, PA — Unoprostone (Rescula, Novartis Ophthalmics) may provide further IOP reduction for patients with advanced glaucoma already receiving multiple other medications, suggests a retrospective study conducted at the Wills Eye Hospital.

The study of medical therapy found that IOP was reduced significantly more in eyes treated concomitantly with unoprostone compared to the fellow eye controls that continued existing therapy.
Mean IOP at baseline was not significantly different between the unoprostone and control eye groups: 21.0 mm Hg compared to 17.0 mm Hg.

During an average follow-up period of nine weeks, 17 (63%) unoprostone-treated eyes achieved some IOP reduction, including eight (30%) with a decrease from baseline of at least 20%. And three eyes (11%) reached a level at least 30% lower than their entry IOP.

Mean IOP fell 2.3 mm Hg (-11%) to 18.7 mm Hg among the unoprostone-treated eyes. Mean IOP dropped only 0.3 mm Hg (-1.8%) to 16.7 mm Hg in the control group, reported Leslie S Jones MD, Assistant Professor at the Department of Ophthalmology, Howard University, Washington, DC. She conducted the retrospective study as a glaucoma fellow at Wills Eye Hospital in collaboration with L Jay Katz MD, Professor of Ophthalmology.

Dr Jones noted that several prospective studies have demonstrated the ocular hypotensive efficacy of unoprostone when used as monotherapy or as a second medication combined with such drugs as pilocarpine or timolol. Furthermore, Japanese researchers reported unoprostone 0.12% reduced IOP by 14% after 2 weeks and 22% after 12 weeks in glaucoma patients to maximum tolerated medical therapy.

“They concluded that the benefit of unoprostone stemmed from its novel pharmacological mechanism of increasing aqueous outflow. Consistent with that research, our retrospective study indicates unoprostone can be considered along with latanoprost or brimonidine as an alternative add-on agent for gaining further IOP reduction in eyes not controlled successfully on maximum tolerated medical therapy,” Dr Jones explained.

The 27 patients included in the study were identified from an ongoing prescription registry and were all being treated at Wills’ glaucoma referral clinic. The diagnoses for the patients included open-angle glaucoma (n=18); low tension glaucoma (n=4); pseudoexfoliation glaucoma (n=3); and chronic angle closure glaucoma (n=2). The mean patient age was
71 years, and the majority of participants were women (59%), white (93%) and had previously undergone filtration surgery. The average patient was being treated with 3 glaucoma medications at the time unoprostone was started.

Benefit not universal
Dr Jones cautioned that not all eyes benefited from the addition of unoprostone. In three (11%) eyes, IOP was unchanged by concomitant unoprostone while IOP increased in six (22%) eyes. Unoprostone treatment was discontinued in 10 eyes (37%) because of uncontrolled IOP. Two other patients stopped treatment because of adverse events that included keratitis and uveitis in one patient and corneal toxicity in the other.

As another caveat, Dr Jones noted that the findings of this study must be interpreted against the background of its limitations. These include a retrospective design, potential for bias from lack of investigator and patient blinding and small sample size.

She added that the referral clinic subjects enrolled represent a highly selected patient population which must be taken into account when considering the generalisation of results.

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