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Preliminary analysis suggests anecortave acetate could provide sustained IOP control
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SINGAPORE — Open-angle glaucoma patients treated with a single sub-Tenon injection of anecortave acetate showed a significant, sustained reduction in IOP over 3 months, according to an interim analysis of data from a clinical study. The results suggest that the drug may have potential for prolonged IOP control, the study authors said.
Alan L. Robin, MD, and colleagues randomly assigned 85 patients to treatment with either one of three doses of anecortave acetate or to vehicle. Specifically, 22 patients received 3 mg of the drug, 20 received 15 mg and 22 received 30 mg. All patients had open-angle glaucoma, off-therapy IOP between 24 mm Hg and 36 mm Hg and glaucomatous visual field changes, according to a press release from Alcon, the drug's developer.
Dr. Robin and colleagues presented the 3-month results in a poster at the World Glaucoma Congress here.
At 3 months, investigators found that anecortave acetate showed the potential for prolonged IOP reduction at all concentrations vs. vehicle (P < .05). Overall, 38% of anecortave acetate-treated patients achieved clinical success, defined as an IOP of 21 mm Hg or less. In particular, 50% of patients treated with 30 mg of the drug achieved success compared with 24% of control patients, according to the study.
The reduction in IOP averaged 7.2 mm Hg among all anecortave acetate-treated patients compared with 1.4 mm Hg for controls (P = .0014). Specifically, the control group had an average 2% IOP decrease compared with 15% for the 3 mg-treated group (P = .0536), 16% for the 15 mg-treated group (P = .0526) and 19% for the 30 mg group (P = .0120).
Also, all three study groups maintained the mean IOP reduction at 3 months, while IOP had returned to baseline values in controls, according to the press release.
The most common adverse events included eye pain, foreign body sensation and blurred vision, with nine of the 14 reports of eye pain associated with the injection. No patients stopped treatment due to any adverse event.
No other adverse events were associated with the drug or injection procedure, the study authors noted.
Researchers will continue with full clinical assessments through at least 6 months, although safety will be evaluated out to 12 months.