Anecortave acetate

Retaane Anecortave acetate Alcon Phase III Exudative AMD Juxtafoveal sub-Tenon s injection... 

Augustin AJ, D Amico DJ, Mieler WF, et al. Safety of posterior juxtascleral depot administration of the angiostatic cortisone anecortave acetate for treatment of subfoveal choroidal neovascularization in patients with age-related macular degeneration. Graefes Arch CUn Exp Ophthalmol 2005 243 9-12. 

D Amico DJ, Goldberg MF, Hudson H, et al. Anecortave acetate as monotherapy for the treatment of subfoveal lesions in patients with exudative age-related macular degeneration (AMD) interim (month 6) analysis of clinical safety and efficacy. Anecortave Acetate Clinical Smdy Group. Retina 2003 23 14. 

Slakter JS, Bochow T, D Amico DJ, et al. Anecortave acetate (15 milligrams) versus photodynamics therapy for treatment of subfoveal neovascularization in age-related macular degeneration. Ophthalmology 2006 113 3. 

Anecortave acetate (RETAANE , Alcon Pharmaceuticals) is an angiostatic agent given as a posterior juxtascleral depot. The drug is under clinical evaluation for the... 

Clark AF, Mellon J, Li X-Y, et al. Inhibition of intraocular tumor growth by topical application of the angiostatic steroid anecortave acetate. Invest Ophthalmol Vis Sci 1999 40 2156-2162. 

The most frequently reported systemic adverse events were hypertension, arthritis, urinary tract infection, and hypercholesterolemia. Of the 36 patients reporting a serious adverse event, 11 exited the study for that reason. Serious adverse events were reported by 23 of the 98 anecortave acetate-treated patients and 13 of the 30 placebo-treated patients. Five deaths from lung carcinoma, heart failure/ cerebrovascular accident, accidental injury, or myocardial infarction were reported. However, none of these serious adverse events or deaths was assessed as related to study treatment. An independent safety committee concluded that there were no clinically relevant medication-related or administration-related safety concerns. 

Phase III Clinical Trials. In view of the positive long-term safety and efficacy outcomes from this study, a Phase III comparison of Anecortave Acetate 15 mg for Depot Suspension (RETAANE 15 mg Depot Alcon Research, Ltd) to vertepor-fin (Visudyne Novartis) PDT for treatment of subfoveal CNV was completed. 

The primary end point was the percentage of patients with fewer than three lines of visual acuity loss. The goal was to demonstrate the noninferiority of anecortave acetate to verteporfin PDT at month 12 after the start of treatment. There was a... 

There was no statistical difference between the anecortave acetate treatment and the PDT treatment outcomes regarding the primary end point of loss of fewer than three lines of visual acuity. In the anecortave acetate group 45% had less than a three-line loss of visual acuity, and in the PDT group, 49% of patients had less than a three-line loss of visual acuity. The statistical end point, however, was not reached regarding noninferiority of anecortave acetate compared with PDT. 

Future Clinical Trials. Study C-04-59 is designed to evaluate the dose and administration frequency of anecortave acetate depot every three months (15 mg) or six months (15 or 30 mg). Inclusion criteria are similar to those of the previous trials. 

Shepard, A.R., Conrow, R.E., Pang, I.-H. et al. (2013) Identification of PDE6D as a molecular target of anecortave acetate via a methotrexate-anchored yeast three-hybrid screen. ACS Chemical Biology, 8, 549-558. 

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