PALM BEACH GARDENS, FL--(Marketwire - October 14, 2010) - Eyetech Inc. announced today a program to develop an extended-release formulation of Macugen® (pegaptanib sodium injection) using microparticles technology. Macugen, a selective inhibitor of VEGF-165, is approved for the treatment of neovascular age-related macular degeneration (neovascular AMD). The goal of the Macugen extended-release formulation is to decrease the frequency of dosing from every six weeks to every four to six months. Eyetech is collaborating with SurModics Pharmaceuticals, Inc., a leading drug delivery company, to develop the extended-release version of Macugen under a licensing and development agreement that was signed in 2005. The development program was announced today at the second annual Ophthalmology Innovation Summit in Chicago.
"An extended-release formulation of Macugen could offer several potential advantages to physicians, patients with neovascular AMD and their families, including a more convenient dosing schedule, improved compliance, and a lower risk of complications related to the injection," said Scott W. Cousins, M.D., project leader for the Macugen Microparticles Program and vice-chair of research in the Department of Ophthalmology at Duke University School of Medicine in Durham, NC. "I look forward to advancing the Microparticles development program."
Neovascular AMD is a chronic condition that requires long-tem treatment. Recent studies evaluating the injection frequency and visual outcomes using anti-VEGF therapies have shown that giving the treatments on an 'as needed' basis leads to under-treatment and significantly less vision gains.(i) In addition, recently published and presented clinical studies have investigated anti-VEGF therapy as a potential treatment for patients with other retina diseases, such as diabetic macular edema (DME) and retinal vein occlusion (RVO). New drug delivery technologies may be of interest to physicians who serve these patient populations.
Mike Atieh, executive chairman of Eyetech Inc., said: "The announcement of the Microparticles program demonstrates our commitment to addressing the needs of the retina community and collaborating to provide safe and effective treatment options for patients suffering from retina disease."
Eyetech Inc. has the worldwide rights to the Macugen Microparticles program.
About Age-Related Macular Degeneration (AMD)
AMD is a chronic, progressive disease of the central portion of the retina called the macula, resulting in the loss of central vision. The most common symptoms are a central blurred or blank spot, distortion of objects or simply blurred vision. Peripheral vision usually remains intact. AMD is classified into two forms: atrophic, referred to as dry AMD, and neovascular or wet AMD.
In neovascular AMD, abnormal blood vessels grow and leak into the macula, resulting in loss of vision. Neovascular AMD is the more severe form of the disease and progresses more rapidly than the dry type. Although it accounts for only about 10-15 percent of all macular degeneration cases, neovascular AMD is responsible for 90 percent of blindness caused by the disease.
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. 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 other excipient of this product.
Safety or efficacy of Macugen beyond two 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 less than 1% of intravitreal injections included endophthalmitis, retinal detachment, and iatrogenic traumatic cataract.
Most frequently reported adverse events in patients treated for up to two 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.
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 about Eyetech, please visit www.eyetech.com.
(i) Dadgostar H, et al. Evaluation of Injection Frequency and Visual Acuity Outcomes for Ranubizumab Monotherapy in Exudative Age-related Macular Degeneration. Ophthalmology 2009; 116:1740-1747.