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Volume 2, Number
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July 2006
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WELCOME | ||
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THE LATEST PUBLISHED RESEARCH | ||
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NOTEWORTHY: FDA APPROVES RANIBIZUMAB (LUCENTIS); PHASE IV TRIAL OF PEGAPTANIB INITIATED; AND MORE ITEMS OF INTEREST | ||
| WELCOME
Welcome to Review of Ophthalmology’s Retina
Online newsletter. Each month, Medical Editor Philip Rosenfeld, MD,
PhD, and our editors provide you with this timely and easily accessible
report to keep you up to date on important information affecting the
care of patients with vitreoretinal disease.
In this edition:
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THE LATEST PUBLISHED RESEARCH Prospective Study of Intravitreal Bevacizumab for AMD Effects of PDT on RPE and Other Cells Enhanced PDT Protocol Appears to be Safe and Beneficial for Central
Serous Chorioretinopathy Source: Lai TYY, Chan W-M, Li H, et al. Safety enhanced photodynamic therapy with half dose verteporfin for chronic central serous chorioretinopathy: a short term pilot study. Br J Ophthalmol 2006;90:869-874. Pathogenesis of Choroidal vs. Retinal Neovascularization Ultrahigh-Resolution OCT of Closed Macular Holes Reveals Abnormalities Increased Optic Disc Cupping Appears to be an Independent Risk Factor
for RVO |
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| NOTEWORTHY: FDA
APPROVES RANIBIZUMAB (LUCENTIS); PHASE IV TRIAL OF PEGAPTANIB INITIATED;
AND MORE ITEMS OF INTEREST FDA Approves Ranibizumab (Lucentis) The U.S. Food and Drug Administration has approved ranibizumab injection (Lucentis 0.5 mg) for the treatment of neovascular AMD. The maker of ranibizumab, Genentech began shipping the product on June 30. Ranibizumab 0.5 mg is recommended for intravitreal injection once a month. If monthly injections are not feasible, treatments can be reduced to one injection every three months after the first four monthly injections. Compared with continued monthly dosing, dosing every three months will lead to an approximate five-letter (one-line) loss of visual acuity benefit, on average, over the following nine months. Patients should be evaluated regularly. According to the FDA, ranibizumab is a new molecular entity, meaning it contains an active substance that has never before been approved for marketing in any form in the United States. It is also the first approved product to use the new format for prescription drug package inserts, the aim of which is to provide professionals and consumers with clear and concise information. The approval of the new treatment is based on data from two Phase III clinical trials (MARINA and ANCHOR). In these studies, approximately 95 percent of patients treated with ranibizumab 0.5 mg maintained visual acuity, and up to 40 percent improved at least 3 lines at one year. On average, patients treated in the MARINA trial experienced an improvement from baseline of 6.6 letters at two years compared with a loss of 14.9 letters in the sham group. In the ANCHOR trial, patients treated with ranibizumab on average experienced an 11.3 letter gain from baseline at one year compared with a loss of 9.5 letters among patients treated with verteporfin PDT. Up to 40 percent of patients treated with ranibizumab achieved vision of 20/40 or better. In clinical trials, the most common adverse reactions among patients treated with ranibizumab (reported in at least 6 percent more patients than in the control groups in at least one study) included conjunctival hemorrhage, eye pain, vitreous floaters, increased intraocular pressure and intraocular inflammation. Although the rate of arterial thromboembolic events observed in the clinical trials was low (less than 4 percent) and not statistically different between the ranibizumab and control groups, the theoretical risk of such events exists following intravitreal use of VEGF inhibitors. Serious adverse events related to the injection procedure occurred in less than 0.1 percent of intravitreal injections, including endophthalmitis, retinal detachments and traumatic cataracts. Other serious ocular adverse events observed among ranibizumab-treated patients (that occurred in less than 2 percent of patients) included intraocular inflammation and increased intraocular pressure. Ranibizumab is contraindicated in patients with hypersensitivity and ocular or periocular infections. In a press release, Genentech stated that it is committed to assisting eligible patients in accessing its therapies for approved indications, regardless of their ability to pay. To learn more about potential financial assistance, patients can call (866) 724-9394 or visit SPOConline.com. Source: Genentech Inc., June 2006. Phase IV Trial of Pegaptanib Initiated OSI Pharmaceuticals and Pfizer have initiated a Phase IV trial to explore the safety and efficacy of pegaptanib sodium injection as a maintenance therapy for patients who have received prior treatment for neovascular AMD and experienced improvement in macular disease. The trial, called LEVEL (EvaLuation of Efficacy and safety in maintaining Visual acuity with sEquential treatment of neovascuLar AMD), will last 54 weeks and involve up to 1,000 patients at 100 sites across the country. The trial is open-label, and subjects must have had at least one but no more than three treatments for neovascular AMD within 30 to 120 days prior to study entry leading to an improvement in macular disease. Pegaptanib will be administered once every six weeks for 48 weeks. Booster treatment with additional neovascular AMD therapy may be employed if the investigator believes macular disease has progressed. The trial’s primary endpoint is the percentage of subjects who remain at baseline vision or gain (greater than or equal to 0 lines) vision from baseline to 54 weeks. Secondary endpoints include: percentage of subjects maintaining or gaining one, two and three lines of visual acuity at week 54 compared with baseline; mean change in visual acuity from baseline to week 54; percentage of subjects losing less than three lines of vision at 54 weeks; and anatomical outcomes on fluorescein angiography and OCT. Source: OSI Pharmaceuticals and Pfizer, June 2006. Phase II Trial of Squalamine for AMD Begins The first patient has been enrolled in a multicenter, open-label, Phase II clinical trial (MSI-1256F-212) exploring the efficacy and safety of higher doses of squalamine lactate (Evizon) for the treatment of neovascular AMD. The study is designed to evaluate up to 140 patients and four dose levels (40 mg, 80 mg, 120 mg and 160 mg) over a 20-week period. Patients and physicians interested in participating in Evizon clinical trials can call (800) 299-9156. Source: Genaera Corp., June 2006. Harvard and Merck to Collaborate on AMD Therapies Harvard Medical School and Merck have signed a multi-million-dollar license agreement to develop potential therapies for AMD. The agreement, which is one of the largest in the medical school’s history, provides Merck with licenses to specific molecules that could ultimately slow the production of toxic byproducts that form in the eye and have been implicated in some forms of AMD and Stargardt’s disease. The agreement also establishes a research collaboration between Merck and Robert Rando, professor of biological chemistry and molecular pharmacology, and provides Merck with exclusive rights to Prof. Rando’s intellectual property in this area. Harvard will receive a $3 million up-front payment, significant milestone fees, and downstream royalties on any marketed products that result from the agreement. Source: Harvard University Gazette, May 2006. |
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