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Eyetech Inc. Release: Post-Hoc Analysis of V.I.S.I.O.N. Trial Data Showed No Association Between Macugen(R) (Pegaptanib Sodium) and Sustained Elevated Intraocular Pressure


11/7/2011 9:51:43 AM

PALM BEACH GARDENS, FL--(Marketwire - November 07, 2011) - Eyetech Inc. today announced that results from a post-hoc analysis of the Phase 3 V.I.S.I.O.N. study showed no apparent association between treatment with Macugen® (pegaptanib sodium) for neovascular age-related macular degeneration (neovascular AMD) and occurrence of sustained elevated intraocular pressure (IOP), a measure of pressure inside the eye. In the analysis, no difference was found between the proportion of patients treated with Macugen and the proportion of patients treated with sham injection who demonstrated sustained elevated IOP over the course of two years of treatment. These findings were presented recently at the annual meeting of the American Academy of Ophthalmology in Orlando.

"Elevated IOP, a major risk factor for glaucoma, has been observed in patients using anti-VEGF therapies, which could represent an additional risk of vision loss for patients already facing the effects of neovascular AMD," said Mauro Goldbaum, M.D., study author and executive director of medical strategy for Eyetech. "While transient injection-related increases in IOP have been seen within 30 minutes of injection with Macugen, this post-hoc analysis suggests that 2-year treatment with Macugen does not lead to sustained elevated IOP -- an important finding as we continue to gain clinical experience with anti-VEGF therapies."

About the Study

In order to assess the rate of sustained IOP elevation associated with Macugen when administered to patients with neovascular AMD, researchers conducted a post-hoc analysis of the Phase 3 V.I.S.I.O.N. study on Macugen® (pegaptanib sodium) for the treatment of neovascular AMD, which combined data from two trials. The analysis included 114 patients who were administered continuous Macugen 0.3 mg for 2 years and 107 patients who received sham injections in the first year followed by either sham or treatment discontinuation in the second year. The median numbers of injections in the pegaptanib 0.3-mg group was 17 injections. The main assessment was the proportion of patients showing sustained high IOP, defined as any IOP measurement ≥22 mmHg taken before the study injection, at the 1-week post-injection visit, or at any unscheduled visit.

In the analysis, no difference was found between the two treatment groups in the proportion of patients with sustained elevated IOP.

In addition, no difference was observed between the treatment groups in the number of sustained elevated IOP events.

"IOP is an important precursor to glaucoma, a condition that can lead to irreversible vision loss if not detected and treated early," said David S. Boyer, M.D. "While further studies are warranted, it is reassuring to find that over the course of two years of treatment, Macugen did not appear to be associated with sustained elevated IOP."

At baseline, nine patients in the Macugen group and seven patients in the sham group had a history of glaucoma. No subject in either group had any surgical procedure for the treatment of chronic glaucoma. No patient discontinued from the study due to increased IOP or signs of progressing glaucoma.

About Macugen
Macugen, a selective inhibitor of VEGF-165, is indicated in the United States for the treatment of neovascular age-related macular degeneration (neovascular AMD) and is administered in a 0.3-mg dose once every six weeks by intravitreal injection. Macugen is a pegylated anti-VEGF aptamer, which binds to vascular endothelial growth factor (VEGF). VEGF is a protein that plays a critical role in angiogenesis (the formation of new blood vessels) and increased permeability (leakage from blood vessels), two pathological processes that contribute to the vision loss associated with neovascular AMD.

Eyetech Inc. markets and sells Macugen in the United States and Pfizer Inc markets and sells Macugen outside of the United States. Eyetech Inc. has the worldwide rights to the Macugen Microparticles program. For full prescribing information about Macugen, please visit http://www.macugen.com/.

Important Safety Information

Macugen is contraindicated in patients with ocular or periocular infections or with known hypersensitivity to pegaptanib sodium or any product components. Safety or efficacy of Macugen beyond 2 years has not been demonstrated. Endophthalmitis may occur following intravitreous injections. Proper aseptic injection technique should always be utilized when administering Macugen. Patients should be monitored during the week following the injection. Increases in intraocular pressure have been seen within 30 minutes of injection of Macugen. Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in the post-marketing experience. Most common adverse reactions in 10%-40% of patients treated for up to 2 years were anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased IOP, ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. Please see full Prescribing Information.

About Eyetech Inc.
Eyetech Inc. is an independent, employee-owned and operated biotechnology company dedicated exclusively to the treatment of sight-threatening diseases of the retina. For additional information about Eyetech, please visit www.eyetech.com.


Contact:
Jennifer Devine
SmithSolve LLC
On behalf of Eyetech Inc.
973-442-1555 ext. 102



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