- Recent Press Releases:
- Phase 3 Study Presented at World Ophthalmology Congress Evaluates Investigational Use of Macugen in Patients with Diabetic Macular Edema
June 5, 2010 - LEVEL Study Published in British Journal of Ophthalmology Evaluates Macugen as Maintenance Treatment for Patients with Neovascular Age-Related Macular Degeneration
May 18, 2010 - Study Published in the American Journal of Ophthalmology Examines Investigational Use of Macugen in Patients with Branch Retinal Vein Occlusion (BRVO)
January 29, 2010 - Study on the Investigational Use of Macugen in Patients with Diabetic Retinopathy Published in the British Journal of Ophthalmology
October 21, 2009
Study on the Investigational Use of Macugen in Patients with Diabetic Retinopathy Published in the British Journal of Ophthalmology
October 21, 2009
Palm Beach Gardens, FL – October 21, 2009 – Eyetech Inc. announced today the publication of data from a randomized, prospective, open-label study evaluating the investigational use of intravitreal Macugen® (pegaptanib sodium injection) compared to pan-retinal laser photocoagulation (PRP) in the treatment of active proliferative diabetic retinopathy (PDR). The article is available in the online edition of the British Journal of Ophthalmology (BJO) and scheduled for publication in the November 2009 issue.
“This limited study suggests that Macugen may have the potential to produce marked and rapid short-term regression of diabetic neovascularization. The fact that the regression was maintained throughout the study is particularly encouraging,” said Victor H. Gonzalez, M.D., lead author of the paper and Medical Director of the Valley Retina Institute in McAllen, Texas. “Further research is needed to determine if Macugen is a safe and effective treatment for PDR. There are currently no approved pharmacologic treatments for patients with diabetic retinopathy.”
In the study, 20 subjects with active PDR were randomly assigned to receive treatment in one eye with either Macugen (0.3 mg) every 6 weeks for 30 weeks, or with PRP laser. The primary endpoint was the regression of PDR from baseline to week 36, defined as regression of neovascularization. All eyes treated with Macugen (N=10) were completely regressed by the end of the study at week 36. Among patients who received PRP (N=9), two showed complete regression, two demonstrated partial regression, and four showed persistent active PDR at week 36.
Investigators reported additional endpoints. At week 3, all eyes treated with Macugen showed at least partial neovascularization (NV), defined as a reduction of more than 50% of the NV size, compared with two eyes in the PRP laser group. Among eyes treated with Macugen, the mean central macular thickness (CMT) was 201 μm at baseline and 191 μm at week 36, compared with 232 μm at baseline and 303 μm for PRP-treated eyes at week 36 (P=0.025 t-test). The mean best-corrected visual acuity (BCVA) score was 76 letters in each treatment arm at baseline and at week 36 the change in mean BCVA from baseline was a gain of 5.8 letters among patients treated with Macugen and a loss of 6.0 letters for the PRP treated arm (P=0.22, not statistically significant).
Mild to moderate transient ocular adverse events were reported with Macugen.
Eyetech is funding an independent study by Dr. Gonzalez to further investigate Macugen for the treatment of diabetic retinopathy. In addition, Eyetech initiated the PRESERVE trial in January 2009 to study 4-week and 6-week dosing regimens of Macugen in patients with DME. A Phase III trial of Macugen for the treatment of DME is being conducted in the European Union.
About Eyetech Inc.
Eyetech Inc. is a unique, independent 100% employee-owned and operated biotechnology company dedicated exclusively to the treatment of sight-threatening diseases of the retina. For additional information, please visit www.eyetech.com.
About Macugen
Macugen (pegaptanib sodium injection), 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.
For full prescribing information about Macugen, please visit http://www.macugen.com/.
Macugen is marketed by Eyetech Inc. in the United States. Pfizer Inc has the exclusive rights to commercialize Macugen in countries outside of the United States.
DISCLOSURE NOTICE: The information contained in this release is current as of the date of publication (October 21, 2009). Eyetech assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
Macugen® (pegaptanib sodium injection) is indicated for the treatment of neovascular age-related macular degeneration.
Important Safety Information
MACUGEN is contraindicated in patients with ocular or periocular infections or with known hypersensitivity to pegaptanib sodium or any other excipient in this product.
Safety or efficacy of MACUGEN beyond 2 years has not been demonstrated.
Intravitreal injections including those with MACUGEN have been associated with endophthalmitis. Proper aseptic injection technique—which includes use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent)—should always be utilized when administering MACUGEN. In addition, patients should be monitored during the week following the injection to permit early treatment, should an infection occur.
Increases in intraocular pressure (IOP) have been seen within 30 minutes of injection with MACUGEN. Therefore, IOP as well as the perfusion of the optic nerve head should be monitored and managed appropriately.
Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in postmarketing experience following the intravitreal administration procedure.
Serious adverse events related to the injection procedure occurring in <1% of intravitreal injections included endophthalmitis, retinal detachment, and iatrogenic traumatic cataract.
Most frequently reported adverse events in 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. These events occurred in approximately 10% to 40% of patients.