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Injectable glaucoma drug shown to reduce IOP in clinical study
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WASHINGTON — Interim results of a 2-year clinical trial show potential for anecortave acetate to significantly reduce IOP with a single anterior juxtascleral injection, according to data from the study presented here at the American Glaucoma Society annual meeting.
The 3-month results showed the safety and efficacy of anecortave acetate (Alcon) ophthalmic suspension in 89 patients with open-angle glaucoma randomly assigned to one of three groups. Patients received either 7.5 mg of anecortave acetate dosed with 0.25 mL of 30 mg/mL suspension, 15 mg dosed with 0.5 mL of 30 mg/mL suspension or 0.5 mL of vehicle.
The interim results were reported by Robert M. Feldman, MD, in a poster at the meeting and in a press release from Alcon.
"Initial 3-month results from this small proof-of-concept study demonstrate the potential for prolonged, less than 3 months reduction (of) IOP with only a single anterior juxtascleral administration of anecortave acetate," Dr. Feldman and colleagues said.
Patients in the study had IOP from 24 mm Hg to 36 mm Hg without medications. Their IOP was measured at 2 weeks, 6 weeks and 3 months. The study is continuing at 6-week intervals, with a possible follow-up of 2 years. Treatment success is being defined as an IOP of 21 mm Hg or lower.
Dr. Feldman and colleagues found that patients treated with either the 7.5 mg or the 15 mg dose of anecortave acetate showed significantly lower mean IOPs compared with vehicle-treated patients at 3 months follow-up. Also, investigators considered nearly 55% of patients in the 7.5 mg and the 15 mg dose groups as successes at 3 months.
In contrast, approximately 50% of patients in the vehicle-treated group were considered treatment failures by the second week, and only two patients were considered treatment successes by 3 months, according to the study.
Adverse effects included eye pain, foreign body sensation and blurred vision. About 64% of eye complaints were related to the injection procedure, Dr. Feldman and colleagues said.
The study results are the second controlled proof-of-concept clinical study of the drug administered as an anterior juxtascleral depot in the sub-Tenon's space, according to Alcon officials. Studies are examining higher doses of the drug for safety and efficacy, officials said.