Volume 2, Number 2
|THE LATEST RESEARCH|
|NOTEWORTHY: RHEOPHERESIS TRIAL FAILS TO MEET PRIMARY ENDPOINT; FDA REQUESTS BSS RECALL; AND MORE ITEMS OF INTEREST|
Welcome to Review of Ophthalmologys Retina Online newsletter. Each month, Medical Editor Philip Rosenfeld, MD, PhD, and our editors provide you with this timely and easily accessible information to keep you up to date on important information affecting the care of patients with vitreoretinal disease.
In this edition:
THE LATEST RESEARCH
Twenty-eight patients with AMD and leaking subfoveal choroidal neovascularization
less than or equal to 12 MPS disc areas in the study eye and best-corrected
visual acuity of 20/200 or worse were given a single intravitreal injection
of AdPEDF. Eight doses, ranging from 106
to 109.5 particle units (PU), were
Intravitreal Bevacizumab for Wet AMD
Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
Source: Intravitreal bevacizumab (Avastin) in the treatment of PDR, Avery RL, 2006 Masters of the American Society of Retina Specialists meeting paper presentation, Rio Grande Puerto Rico.
VISION Subgroup Analyses Suggest Benefit of Early CNV Treatment
Candidate Gene Study Implicates VEGF, VLDLR, and LRP6 in AMD
Transplanted Iris Pigment Epithelial Cells Well-Tolerated after
Panretinal Laser and Triamcinolone for Diabetic Retinopathy and
| NOTEWORTHY: RHEOPHERESIS
TRIAL FAILS TO MEET PRIMARY ENDPOINT; FDA REQUESTS BSS RECALL; AND MORE
ITEMS OF INTEREST
Rheopheresis Trial Fails to Meet Primary Endpoint
OccuLogix Inc. announced that its MIRA-1 Phase III clinical trial of rheopheresis for the treatment of dry AMD did not meet its primary endpoint. The treatment group demonstrated a positive response, but the trial did not demonstrate a statistically significant difference in mean change in BCVA between the treated and control groups at 12 months. The company said an anomalous response of the control group is the principal reason that the primary efficacy endpoint was not met. Treated subgroups did demonstrate statistical significance in mean change in BCVA vs. controls, and further data analyses are under way.
Source: OccuLogix Inc., February 2006.
FDA Requests BSS Recall
The U.S. Food and Drug Administration asked Cytosol Laboratories Inc., of Braintree, Mass., to recall all brands and sizes of Balanced Salt Solution that Cytosol manufactures. Product lots were found to have elevated levels of endotoxin. The FDA has received complaints relating to injuries in more than 300 patients who were given BSS manufactured by Cytosol. Approximately 1 million units of the BSS products were distributed between December 2003 and December 2005 under three labels: AMO Endosol (Advanced Medical Optics Inc.), Cytosol Ophthalmics (Cytosol Ophthalmics), and Akorn (Akorn Inc.).
Physicians can direct questions to the FDA at 1 (888) 463-6332 and should report any adverse reactions associated with these products to the MedWatch Program at www.fda.gov/medwatch/report.htm or 1 (800) FDA-1088.
Source: U.S. Food and Drug Administration, February 2006.
Pegaptanib Receives Approval in Europe; Companies Collaborate on Sustained Release Delivery
The European Commission has granted regulatory approval to pegaptanib sodium for the treatment of neovascular AMD. Pegaptanib had already been approved in the United States, Canada, Brazil, Argentina, Peru, Pakistan and the Philippines, and is awaiting approval in 15 other countries, including Australia, Switzerland and Mexico. It was also recently announced that PR Pharmaceuticals Inc. (PRP) has entered into an agreement with OSI Pharmaceuticals to collaborate on the development of a sustained release formulation of pegaptanib sodium injection for wet AMD. The agreement grants OSI an exclusive license to use PRPs proprietary ProPhase encapsulation technology with respect to pegaptanib in the treatment of eye diseases.
Source: OSI Pharmaceuticals, February 2006, and PR Pharmaceuticals Inc., January 2006.
Preliminary Phase I VEGF Trap Results Presented
At the Bascom Palmer Eye Institutes Angiogenesis 2006 symposium in Miami, Regeneron Pharmaceuticals Inc. presented preliminary results from its ongoing Phase 1, dose-escalation study of VEGF Trap for the treatment of wet AMD. The protein-based VEGF Trap binds all forms of VEGF-A and the related Placental Growth Factor, preventing their interaction with cell-surface receptors and the subsequent formation of new blood vessels. Eighteen patients have received a single intravitreal dose of the VEGF Trap at levels up to 2 mg. A maximum tolerated dose has not been reached, and no evidence of ocular inflammation has been observed. The company reported that patients have shown rapid and substantial reductions in retinal thickness lasting up to at least four weeks. A 4-mg dose is now being tested.
Source: Regeneron Pharmaceuticals Inc., February 2006.
Company Discontinues Macular Edema Trials
Inspire Pharmaceuticals decided to discontinue two Phase II pilot clinical trials that were designed to evaluate denufosol tetrasodium intravitreal injection in patients with macular edema. The first trial was scheduled to enroll 15 patients with persistent macular edema associated with uveitis. The treatment and evaluation of 12 patients showed no significant safety problems, but did not show reduction of retinal thickness or improvement in visual acuity. The second trial was to evaluate denufosol in patients with persistent macular edema following cataract surgery. No patients had been enrolled. The company has stopped enrollment in both trials but will continue to follow the treated patients for one year, as specified in the protocol.
Source: Inspire Pharmaceuticals Inc., January 2006.
Collaboration to Focus on Combination Therapies
CombinatoRx Inc. and Fovea Pharmaceuticals SA reported that they will collaborate to develop and commercialize combination drugs to treat ophthalmic diseases. The agreement unites CombinatoRxs leadership in the discovery of novel combination drug candidates with Foveas drug development resources and expertise in the field of ophthalmic therapeutics, retinal pathologies in particular. For more information about each of the companies, visit www.fovea-pharma.com and www.combinatorx.com.
Source: CombinatoRx Inc., January 2006.
Novartis to Co-Promote Fluocinolone Implant
Bausch & Lomb and Novartis Ophthalmics have agreed that Novartis will co-promote B&Ls fluocinolone acetonide intravitreal implant (Retisert) for the treatment of chronic noninfectious posterior segment uveitis. The Novartis retinal sales team will supplement the efforts of B&Ls U.S. pharmaceutical sales representatives. B&L remains responsible for marketing and product strategy.
Source: Bausch & Lomb, February 2006.
Phase II Trials of RNAi Therapy for AMD and DME Progress
Acuity Pharmaceuticals completed the patient dosing component of its Phase II CARE trial of Cand5 for the treatment of wet AMD. Results from the randomized, double-masked trial, which involves 129 patients and three dose levels, are expected by mid-year. CARE is the first-ever Phase II efficacy trial of a small interfering RNA therapy that targets the genes responsible for production of vascular endothelial growth factor.
Acuity also reported that it has begun dosing patients in a pilot Phase II trial (RACE) of Cand5 for diabetic macular edema. RACE is 48-patient, multicenter, double-masked, randomized trial evaluating the safety and preliminary efficacy of three dose levels. Completion is expected by the end of 2006.
Source: Acuity Pharmaceuticals, February 2006.
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