News

A fusion protein that is an anti-vascular endothelial growth factor agent (VEGF Trap-Eye, Regeneron Pharmaceuticals) significantly reduced retinal thickness from baseline and significantly improved visual acuity in a double-masked, randomized trial with five dosing arms and both monthly and quarterly dosing intervals. Although improvements occurred in all dosing arms, the effects were more consistent in the monthly groups.

A small group of patients given 2.5-mg injections of bevacizumab (Avastin, Genetech) to treat age-related macular degeneration had less frequent injections and slightly better visual acuity than those receiving a 1.25-mg injection over an 8-month follow-up period.

An international, phase II, randomized, double-blind, sham-controlled study evaluated pegaptanib sodium (Macugen, OSI Eyetech/Pfizer) for the treatment of macular edema secondary to central retinal vein occlusion. Results after 30 weeks showed significant benefits of treatment for improving vision and reducing edema.

Two-year results of an exploratory study using an optical coherence tomography-guided variable dosing regimen with ranibizumab in patients with age-related macular degeneration showed that patients maintained visual acuity improvements achieved after an initial series of three monthly injections.

A phase I trial has begun investigating intravitreal injection with a complement inhibitor (POT-4, Potentia Pharmaceuticals) in patients with active choroidal neovascularization secondary to age-related macular degeneration. There is a solid scientific basis for developing complement inhibition as a therapeutic strategy, particularly for treating patients with early disease to prevent progression.

A novel method of delivering drug to the retina using Aerosolized nanoparticles delivered during the air-fluid phase of pars plana vitrectomy may allow ophthalmologists to intervene with the disease process. Research using the technology on pig eyes showed that it seems to provide an effective concentration of drug to the posterior segment tissues. This mode of drug delivery could be effective for treating various eye diseases during surgery.

The Rubeosis Anti-VEGF (RAVE) trial is investigating intravitreal ranibizumab (Lucentis, Genentech) for the treatment of eyes with ischemic central retinal vein occlusion. After receiving nine monthly injections, retinal edema was resolved in nine of 10 eyes, six eyes gained 4 lines in ETDRS visual acuity, and no eyes developed neovascular glaucoma.

With advances in the treatment of age-related macular degeneration, consideration is being given to modifying the frequent dosing that is characteristic of the most recent innovation, the vascular endothelial growth factor inhibitors. The long-term results of this strategy warrant investigation.

The effects of topical bromfenac 0.09% ophthalmic solution (Xibrom, ISTA Pharmaceuticals) on cystoid macular edema were evaluated in 17 eyes with associated retinal disease. After 6 to 28 weeks of treatment, the majority of eyes showed a positive response based on decreases in OCT-measured subfield thickening, cystic spaces, or both.

Bevasiranib (Opko Health Inc.), the first small interfering RNA compound to be tested in humans, was well-tolerated and demonstrated good safety and biologic activity in phase II trials of patients with subfoveal exudative age-related macular degeneration (AMD) or diabetic macular edema. A phase III study investigating bevasiranib as maintenance therapy after ranibizumab (Lucentis, Genentech) treatment is under way in patients with AMD, and a second AMD protocol is under development.

Both anatomic and visual successes are possible when performing plasmin enzyme-assisted vitrectomy for primary and reoperated eyes with stage 5 retinopathy of prematurity. A review of cases performed over a 10-year period showed that about 70% of eyes had light perception vision or better, and nearly as many had successful reattachment.

The FDA has approved the fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% (Combigan, Allergan). The product is considered a useful new option for add-on or replacement therapy in patients requiring additional IOP lowering.

Alcon Laboratories received an approvable letter from the FDA for 15 mg anecortave acetate depot suspension (Retaane) for the treatment of wet age-related macular degeneration (AMD). The letter advised Alcon that approval will require an additional clinical study. The company said it has no immediate plans to conduct a new study of anecortave acetate depot suspension for the treatment of wet AMD, due to the difficulty of recruiting patients for such a study in light of other treatments currently available.

The retina community is greatly concerned about Genentech Inc.'s decision to embargo sales of bevacizumab (Avastin) to compounding pharmacies, which divide the large vials into single-use injections for off-label use in treating wet age-related macular degeneration (AMD) and additional disorders.

Ocular surface disease (OSD) is a common complaint in glaucoma practices because of the high prevalence of both conditions in elderly patients and the pattern of medication usage among glaucoma patients. However, addressing OSD while not eroding gains made in treating the glaucoma is a challenge that must be addressed by strategies other than increasing the frequency of dosing with artificial tears or recommending tears with greater viscosity. To adequately manage OSD requires detective work, appropriate intervention, and chair time, said Donald L. Budenz, MD, MPH, professor of ophthalmology, epidemiology, and public health at the University of Miami Miller School of Medicine.

John P. Berdahl, MD, of the Duke University Eye Center, Durham, NC, won first-place honors in the fifth annual Ophthalmology Times Resident Writer's Award program, it was announced Sunday evening in a dinner presentation at the New Orleans Ritz-Carlton. The program was sponsored by Advanced Medical Optics (AMO).

Management of glaucoma progression is an ongoing process requiring frequent surveillance and monitoring to prevent visual impairment and maintain the quality of life. Experts in a panel discussion of progression agreed on the importance of frequent testing and the use of computerized diagnostic tools to assist in the monitoring. The glaucoma experts participated in a continuing medical education symposium Saturday evening at the Sheraton New Orleans Hotel.

The incidence of dry eye has been increasing for more than a decade and will continue to do so as the percentage of the population over the age of 50 increases. The impact will be felt on patient quality of life as well as in financial costs directly and indirectly attributable to dry eye, making it all the more urgent for clinicians to become adept at managing this condition.

Irvine, CA-ISTA Pharmaceuticals Inc. has licensed exclusive North American rights to nasal dosage forms of bepotastine, an investigational product for the treatment of allergy symptoms, from Tanabe Seiyaku Co. Ltd.

A new visual function test (Heidelberg Edge Perimeter, Heidelberg Engineering GmbH) has been launched. Developed for the early detection of functional damage in glaucoma patients, the instrument uses a unique stimulus called flicker defined form to target magnocellular projecting retinal ganglion cells.

Although prospective, randomized trials have their limitations, they have been successful at identifying a series of risk factors for development of primary open-angle glaucoma. Population-based studies and the acquisition of clinical data by high-tech instruments also may help identify patients at high risk of developing glaucoma.

The corneal penetration of a proprietary formulation of timolol maleate ophthalmic solution 0.5% (Istalol, ISTA Pharmaceuticals) is significantly greater than that of a proprietary formulation of timolol hemihydrate ophthalmic solution 0.25%/0.5% (Betimol, Vistakon Pharmaceuticals) although both drugs are forms of timolol. Better penetration is correlated with improved safety and efficacy, considerations that are part of the selection of a beta-blocker for control of IOP.

Glaucoma surgery with a novel device (Trabectome, NeoMedix Corp.) is a minimally invasive approach that reduces IOP by about 40% with few complications. Data from a case series of 358 eyes showed that IOP dropped from a preoperative mean of about 24 mm Hg to a mean of 16 mm Hg postoperatively.

The Multicenter Uveitis Steroid Treatment (MUST) trial is a National Eye Institute-sponsored phase IV study comparing the fluocinolone acetonide 0.59-mg implant (Retisert, Bausch & Lomb) with standard systemic therapy for the treatment of noninfectious intermediate, posterior, or panuveitis. Its results are intended to help define the role of implant therapy for the treatment of uveitis. Enrollment is ongoing and referral of potentially eligible patients is encouraged.

Elevated IOP is a common occurrence in patients with uveitis. Management often is quite challenging, however, due to the multiple mechanisms that are at play and the often-countervailing effects of corticosteroids and pressure-lowering agents. Several experts comment on their approaches to managing elevated IOP in patients with uveitis, including the use of drops, laser therapy, and surgery.

Recent advances in anterior segment imaging enable ophthalmic surgeons to evaluate, treat, and follow their cataract, refractive, and glaucoma patients better. Three different technologies-optical coherence tomography, a Scheimpflug camera, and a wide-field contact digital fundus camera-are now being used to assess those patients more precisely for diagnosis, possible treatment, and long-term follow-up.

The methodology of several large, multicenter trials of amblyopia treatment leaves several questions unresolved, according to an orthoptist who reviewed the studies. These questions relate to the association between patient age and treatment results, the treatment protocol, measurement of therapy adherence, visual acuity results, and the definition of therapy success.

The Pediatric Eye Disease Investigator Group has conducted several studies recently that are helping to clarify the effectiveness of various approaches to amblyopia treatment and evaluate the effectiveness of therapies in different age groups.