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Abstract #9850 Published in IGR 5-3
Prevention of corticosteroid-induced intraocular pressure elevation using ISV-205
Stewart WC; ISV-205 Study GroupArchives of Ophthalmology 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. The authors 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 six weeks. RESULTS: During the treatment period, the mean ± SD maximum IOP increase (7.3 ± 6.5 mmHg for vehicle, 4.9 ± 4.6 mmHg for 0.06% ISV-205, and 5.9 ± 4.9 mmHg for 0.1% ISV-205) was significantly less with the 0.06% formulation than with placebo (p = 0.02). The overall mean change in IOP was 3.6, 2.0, and 2.4 mmHg 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 = 0.05). Eight (17%) of the 46 subjects receiving vehicle terminated the study because of high IOPs, compared with one (2%) of the 45 subjects receiving 0.06% ISV-205 and three (7%) of the 45 subjects receiving 0.1% ISV-205 (p = 0.03). The number of subjects with a clinically important corticosteroid response (≥10-mmHg increase) was greater in the vehicle group (12 (28%) of 43 subjects) compared with the 0.06% ISV-205 group (three (7%) of 42 subjects) (p = 0.01). 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.
Dr. W.C. Stewart, Pharmaceutical Research Network, LLC, Charleston, SC 29412-2464, USA. prnc@bellsouth.net
Classification:
9.4.1 Steroid-induced glaucoma (Part of: 9 Clinical forms of glaucomas > 9.4 Glaucomas associated with other ocular and systemic disorders)
