Helping Preserve Vision by Slowing Vision Loss

MACUGEN^® (pegaptanib sodium injection) is indicated for the treatment of neovascular AMD¹

Broad Patient Enrollment Criteria in the V.I.S.I.O.N. Study

• Two randomized, controlled, double-masked, multicenter trials of ~1200 patients with subfoveal neovascular AMD^1,2
• All subtypes¹
• Lesion size up to 12 disc areas¹
• Best corrected visual acuity from 20/40 to 20/320 (mean: ~20/100)^1,3
• Patients were randomized to receive MACUGEN 0.3 mg, 1 mg, or 3 mg administered as intravitreal (n=892) injections or sham
  injections (n=298) every 6 weeks¹
• Photodynamic therapy with verteporfin was allowed at physicians’ discretion only for predominantly classic lesions in all treatment arms, per product labeling^1-3
  • Sham was considered "usual care" for patients with neovascular AMD^1-3

Demonstrated Efficacy With MACUGEN

Mean Changes in Visual Acuity Based on Secondary End Point Analysis

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No One Subgroup Drove Overall Treatment Effect of MACUGEN^® (pegaptanib sodium injection)¹

• MACUGEN is the only therapy FDA approved to treat all subtypes of neovascular AMD¹
  
  

Angiographic Subtype

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Lesion Size

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Legal Blindness

• Patients less likely to progress to legal blindness¹
• Results from prespecified end point analyses of legal blindness in study eye¹

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Patients More Likely to Experience Stabilized Vision

• 33% of patients receiving MACUGEN 0.3 mg (98/294) gained ³ 0 letters of vision versus 23% of patients receiving usual care (67/296) (secondary end point, P<.05)^1,2
• 6% of patients receiving MACUGEN 0.3 mg (18/294) gained ³ 15 letters of vision versus 2% of patients receiving usual care (6/296) (secondary end point P<.05)^1,2

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Helping Preserve Vision With 2-Year Efficacy

• At week 54, ~1050 of the original ~1200 patients were rerandomized¹
• MACUGEN 0.3 mg, 1 mg, and 3 mg was either continued or discontinued¹
• Usual care was either continued, discontinued, or switched to 1 of 3 doses of MACUGEN¹
• Dosing with MACUGEN continued every 6 weeks, with photodynamic therapy allowed at physicians' discretion only for predominantly classic lesions in all arms¹

MACUGEN^® (pegaptanib sodium injection) helps slow vision loss through 2 years¹

• 59% of patients receiving MACUGEN 0.3 mg (78/133) lost <15 letters at week 102 versus 45% of patients receiving usual care (48/107) (P<.05)¹
• Study EOP1003: 57% with MACUGEN versus 56% with usual care¹
• Study EOP1004: 61% with MACUGEN versus 34% with usual care¹

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Discontinuation of Treatment Was More Likely to Result in Moderate Vision Loss

• MACUGEN was less effective during the second year than during the first year¹

Consistent with natural history of neovascular AMD…

• Patients treated with MACUGEN lost proportionally less vision as the disease progressed¹
• However, patients continuing to receive MACUGEN lost less vision than did patients continuing to receive usual care through 2 years¹
• Safety or efficacy of MACUGEN beyond 2 years has not been demonstrated¹

Questions about MACUGEN? Contact our support line at 1.800.438.1985.

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References:

1. Data on file. Pfizer Inc, New York, NY.
2. Gragoudas ES, Adamis AP, Cunningham ET Jr, Feinsod M, Guyer DR, for the VEGF Inhibition Study in Ocular Neovascularization Clinical Trial Group. Pegaptanib for neovascular age-related macular degeneration. N Engl J Med. 2004;351:2805-2816.
3. Visudyne [package insert]. Duluth, Ga: Novartis Ophthalmics Inc; 2003.
4. Ambati J, Ambati BK, Yoo SH, Ianchulev S, Adamis AP. Age-related macular degeneration: etiology, pathogenesis, and therapeutic strategies. Surv Ophthalmol. 2003;48:257-293.