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New medication for Glaucoma?

Submitted by Marcel on Wed, 04/23/2008 - 6:41pm

Dear all,


Please find below some research on new Glaucoma medication developments, mind you; not available from your local shop yet!


Alcon Presents Clinical Trial Data on Anecortave Acetate for Glaucoma

Alcon, Inc. ACL released today the primary efficacy and safety results of the second controlled proof of concept clinical study of anecortave acetate administered as an anterior juxtascleral depot in the sub-Tenon's space to reduce intraocular pressure in patients with open-angle glaucoma. These initial data were presented at a clinical investigator's meeting held in association with the annual meeting of the American Glaucoma Society in Washington, DC.

In this safety and efficacy study, 89 patients were randomly assigned to one of three arms: 7.5mg of anecortave acetate dosed with 0.25 mL of 30 mg/mL suspension, 15mg of anecortave acetate dosed with 0.5 mL of 30mg/mL suspension or 0.5 mL of vehicle. Prior to enrolling in the study, all patients had been diagnosed with open-angle glaucoma, had confirmed visual field changes and had off-therapy intraocular pressures (IOP) between 24 mmHg and 36 mmHg. One injection of drug or vehicle was administered to each patient and intraocular pressures were assessed at two weeks, six weeks and at month three, with month three predefined as the visit for primary efficacy. The study design also allowed for a patient to be retreated if more than 42 days had passed since the last administration of anecortave acetate and the patient's intraocular pressure exceeded 18 mmHg in two consecutive visits scheduled one week apart. The study will continue with clinical assessments at six-week intervals, potentially through month twenty four. The presented results are based on the intent to treat data set of all 89 patients.

As explained during the presentation, the primary conclusion was that both the 7.5 mg and 15 mg doses of anecortave acetate demonstrated statistically significant lower mean IOP than vehicle at the month three primary efficacy end-point (ANOVA p less than 0.05). Additional data in the presentation supported the activity of anecortave acetate in lowering IOP. Approximately 55 percent of patients in the 7.5 mg and the 15 mg arms who were treated with anecortave acetate according to the study design were deemed successes at month three. These data contrast with the vehicle treatment group, where approximately 50 percent of patients were treatment failures by week 2 and two patients (6.4 percent) were treatment successes at month three. Treatment success was pre-defined in the study as maintenance of IOP at or below the 21 mmHg. Taken together, these data support the activity of anecortave acetate and also the company's prior decision to conduct additional clinical trials involving higher concentrations of drug.

In terms of safety, the most frequently reported adverse events were related to the procedure and included eye pain, foreign body sensation, hyperemia and blurred vision, which were reported at an incidence of 5 percent to 15 percent. The most frequently reported events related to test article were conjunctival deposits and eye pain which were reported at an incidence of less than 5 percent.

"The safety and efficacy demonstrated in this second controlled clinical study of anecortave acetate are encouraging because they confirm a prolonged treatment benefit for anecortave acetate administered by anterior juxtascleral delivery," said Scott Krueger, PhD, Alcon's vice president, R&D, Pharmaceutical Development. "These results, together with our recently conducted Phase I safety evaluation of larger doses and injection volumes, allows us to proceed in 2008 with studies that evaluate higher doses and injection volumes in our Phase II/III clinical development program."



ARVO 2008 extract:



Abstract Title:

Anterior Juxtascleral Depot of Anecortave Acetate: Intraocular Pressure Reduction in Different Types of Glaucoma

Presentation Start/End Time:

Monday, Apr 28, 2008, 8:30 AM -10:15 AM


Hall B/C

Reviewing Code:

202 glaucoma: clinical drug studies and clinical trials - GL

Author Block:

T.S. Prata, I.M. Tavares, P.A.A. Mello, C.Y. Tamura, R. Belfort, Jr.. Ophthalmology, Federal University of Sao Paulo / UNIFESP-EPM, Sao Paulo, Brazil.


567 intraocular pressure, 560 injection, 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials

Purpose: To evaluate the efficacy and safety of anecortave acetate (AA) anterior juxtascleral depot (AJD) injection to reduce intraocular pressure (IOP) in glaucoma patients.
Methods: We conducted a prospective, non-randomized open-labeled clinical trial in 25 eyes of 25 uncontrolled glaucoma patients. All received a single AJD of AA (30 mg) in the selected eye under topical anesthesia. IOP was measured and adverse events were assessed at week 1, 1 month and 3 months.
Results: Mean age was 60 (+/- 17) years. Most of the patients presented primary open angle glaucoma (8 - 32%) or uveitic / steroid induced glaucoma (9 - 36%). Regarding gonioscopy, 48% of the patients had an open angle, 12% < 90° of angle closure, and 40% >90° of angle closure. Mean IOP at baseline was 30.9 (+/- 9.2) mmHg and 53.5% of the patients had prior intraocular surgery. Mean IOP at the first three months were 20.9 (+/-7.5) mmHg, 21.5 (+/-7.6) mmHg and 19.1 (+/- 5.2) mmHg, respectively. Mean IOP reduction of 33.3%, 31.7% and 38.3% were observed at the first, second and third month, respectively. At month 3, angle closure glaucoma eyes had a mean IOP of 17.4 mmHg (reduction of 43.7%) while open angle glaucoma eyes had a mean IOP of 20.7 (reduction of 32.9%). A mild subconjunctival hemorrhage was observed in four cases. One eye developed a small and transient corneal dellen at the first week.
Conclusions: AA administered as an AJD presented a significant IOP reduction for at least three months with no clinically apparent serious adverse events in eyes with different types of glaucoma.

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