Eyeworld.org EW Week Vol.13 No.1

InSite begins Phase III blepharoconjunctivitis trial

Sat, 05 Jan 2008 00:00:28 -0500

InSite Vision (Alameda, Calif.) has initiated pivotal Phase III clinical trials to evaluate AzaSite Plus for the treatment of blepharoconjunctivitis, the company said in a press release. AzaSite Plus, formulated in InSite’s DuraSite sustained delivery vehicle, is a topical combination antibiotic/corticosteroid product being developed to provide simultaneous antimicrobial and anti-inflammatory treatments.

Brachytherapy implants for ocular cancer

Sat, 05 Jan 2008 00:00:28 -0500

Proxcelan (Cesium-131), brachytherapy seeds for cancer and solid tumor treatment, is now being used to treat ocular melanoma, said developer IsoRay (Richland, Wash.). Earlier this month, surgeons at Tufts-New England Medical Center, Boston, implanted three patients with Cesium-131. The treatment has been approved for the treatment of soft tissue cancers since 2004 in the U.S. During the procedures, Cesium-131 brachytherapy seeds, encased in a small disc-shaped shield (plaque) with a protective gold backing, were attached to the surface of the patients\' eyes over the area to be treated. The plaques were scheduled to be removed on December 17, 2007, said Mark J. Rivard, Ph.D., associate professor of radiation oncology at Tufts University School of Medicine and Chief Medical Physicist at Tufts-New England Medical Center. Plaque brachytherapy is a proven radiation treatment for intraocular melanoma, with Iodine-125 being the most common isotope associated with this radiation treatment option to date. Advances in radiation therapies have led to a decrease in the number of patients treated by enucleation, or removal of an affected eye. “Brachytherapy has been most effective for small- to medium-sized tumors,” Dr. Rivard said. “Under those conditions, we anticipate that in most cases patients can be cured and their vision saved using brachytherapy.”

ISTA submits NDA

Sat, 05 Jan 2008 00:00:28 -0500

ISTA Pharmaceuticals (Irvine, Calif.) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for Xibrom (bromfenac) QD, according to a press release. ISTA is seeking approval for Xibrom QD as a treatment for inflammation, pain, and photophobia following cataract surgery. Xibrom is a topical non-steroidal anti-inflammatory drug for the currently approved in the U.S. for twice-daily dosing for the treatment of ocular inflammation and pain following cataract surgery.

Genentech, AAO, ASRS reach agreement on Avastin

Sat, 05 Jan 2008 00:00:28 -0500

Genentech (South San Francisco, Calif.) has worked out a deal with the American Society of Retina Specialists (ASRS) and the American Academy of Ophthalmology (AAO) to allow physicians to purchase Avastin (bevacizumab) directly from authorized wholesale distributors who will then ship the compound to the physician’s destination of choice, including compounding pharamacies. Earlier this year, Genentech announced it would no longer be shipping the cancer drug to compounding pharmacies, citing the Food and Drug Administration’s concerns with sterilization issues at a compounding pharmacy. Retinal specialists have been vocal about their ability to use the cancer drug off-label to treat wet age-related macular degeneration (AMD), and have at times balked at the more expensive approved therapy, Lucentis (ranibizumab). “This process is one that the AAO and ASRS believe addresses the needs of their members. It is a significant step forward, reflecting the collaborative approach of Genentech and AAO and ASRS leadership,” Genentech said in a press release. Genentech continues to state Lucentis is the “most appropriate treatment for patients with wet AMD because it was specifically designed, formally studied, approved by the U.S. Food and Drug Administration and manufactured for intraocular delivery for the treatment of wet AMD. At the same time, Genentech does not interfere with physicians’ prescribing choices and believes that physicians should be able to prescribe the treatment they believe is most appropriate for their patients.” Genentech added it is working with the AAO and ASRS to develop additional programs to expedite patient access to and physician reimbursement for Lucentis. Siobhan Bunaes, an AAO spokeswoman, said Genentech assured the group it would not raise the price of Avastin.