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William C. Stewart, MD; for the ISV-205 Study Group

Arch Ophthalmol. 2003;121:1543-1547.

Objective  To determine whether a topical ophthalmic diclofenac sodium formulation containing a proprietary polymeric drug delivery system (ISV-205), when dosed concomitantly with 1% prednisolone acetate, is effective in blocking the intraocular pressure (IOP) response in humans.

Design  This was a multicenter, prospective, double-masked, parallel, vehicle-controlled study. We included 136 first-degree relatives of subjects with primary open-angle glaucoma. Subjects were randomized to receive 0.06% or 0.1% ISV-205 or vehicle while concomitantly receiving 1% prednisolone for 6 weeks.

Results  During the treatment period, the mean ± SD maximum IOP increase (7.3 ± 6.5 mm Hg for vehicle, 4.9 ± 4.6 mm Hg for 0.06% ISV-205, and 5.9 ± 4.9 mm Hg for 0.1% ISV-205) was significantly less with the 0.06% formulation than with placebo (P = .02). The overall mean change in IOP was 3.6, 2.0, and 2.4 mm Hg in the vehicle, 0.06% ISV-205, and 0.1% ISV-205 groups, respectively, which was significant between the 0.06% ISV-205 and vehicle groups (P = .05). Eight (17%) of the 46 subjects receiving vehicle terminated the study because of high IOPs, compared with 1 (2%) of the 45 subjects receiving 0.06% ISV-205 and 3 (7%) of the 45 subjects receiving 0.1% ISV-205 (P = .03). The number of subjects with a clinically important corticosteroid response (10–mm Hg increase) was greater in the vehicle group (12 [28%] of 43 subjects) compared with the 0.06% ISV-205 group (3 [7%] of 42 subjects) (P = .01). Adverse events were similar between treatments.

Conclusions  This study suggests that ISV-205 limits the corticosteroid-induced elevated IOP in first-degree relatives of subjects with glaucoma. Future studies are needed to confirm these results and explore the possible role of this drug in treating glaucoma.

From the Pharmaceutical Research Network, LLC, Charleston, SC. A list of the clinical investigators of the ISV-205 Study Group appears on page 1547. Mitchell H. Friedlaender, MD, is the director and a shareholder of InSite Vision Incorporated, the company that sponsored this study.

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