Alcon Terminates Development Of AMD Treatment

Alcon has terminated the development program designed to evaluate the benefit of anecortave acetate for reducing the risk of the progression from the dry form of age-related macular degeneration to the wet form of the disease, Alcon announced in a press release.

Retaane (anecortave acetate) ophthalmic suspension is an angiostatic cortisene that inhibits the abnormal growth of blood vessels, according to Alcon literature. The drug received an approvable letter from the U.S. Food and Drug Administration last year.

The decision to terminate the development program follows a planned interim analysis of studies that was performed after 2,546 patients had completed the 24-month time point. In this analysis, anecortave acetate showed no effect on primary or secondary endpoints.

Alcon has also terminated two identically designed smaller studies that were being conducted in Asia.

The company will continue to study anecortave acetate administered as an anterior juxtascleral depot for reducing IOP in patients with open-angle glaucoma, the release said.

Diabetic Retinopathy Not The Primary Cause Of Visual Loss In Diabetic Patients, Study Finds

The majority of visual loss among patients with diabetes appears to be attributable to causes other than diabetic retinopathy, according to a large, randomized study by researchers in the United Kingdom.

Peter H. Scanlon, MBBS, MD, FRCP, DCH, DRCOG, DO, MRCOphth, and colleagues at Cheltenham General Hospital obtained standardized logMAR BCVA measurements and slit-lamp biomicroscopy examinations for 1,549 patients with diabetes selected from a digital photographic screening program. The investigators evaluated the relationship between BCVA, age, diabetes type, sight-threatening diabetic retinopathy and ocular comorbidity. They published their results in the June issue of British Journal of Ophthalmology.

Subnormal vision of 0.3 logMAR or higher in the better-seeing eye was found in 9% of patients; blindness of 1.3 logMAR or higher in the better-seeing eye was found in 0.45% of patients.

Important contributory causes of moderate loss (logMAR visual acuity between 0.50 and 0.98) and of acuity blindness (logMAR higher than 1.0) in an individual eye were lenticular opacity in 49% of patients, macular degeneration in 29% of patients, diabetic maculopathy in 15% of patients, other media causes—including corneal opacity—in 13% of patients, and amblyopia in 10% of patients, according to the study.

Ranibizumab Cost-Effective, Confers Greater Value In Wet AMD Patients

Using intravitreal ranibizumab for occult or minimally classic subfoveal choroidal neovascularization due to age-related macular degeneration is a cost-effective therapy, according to an analysis of data from the MARINA study.

Using primary data and 2006 incremental costs from the MARINA (Minimally classic/occult trial of the anti-vascular endothelial growth factor antibody ranibizumab in the treatment of neovascular AMD) trial, Melissa M. Brown, MD, MBA, and colleagues evaluated the conferred value and average cost-utility of intravitreal Lucentis (ranibizumab, Genentech) administered to 716 patients with occult or minimally classic subfoveal choroidal neovascularization due to AMD. Results included data for the second-eye model, the first-eye model and the combined model.

Conferred value included quality-adjusted life years (QALY) and percentage of improvement in health-related quality of life; average cost-utility was expressed in terms of dollars expended per QALY gained.

A total of 53.6% of patients in the MARINA study were first-eye cases who had better vision in the unaffected eye, whereas 46.4% of patients were second-eye cases who already had poor vision in the fellow eye contralateral to the randomized eye, the authors noted.

In the second-eye model, the total value conferred by an average of 22 intravitreal injections of 0.5 mg of ranibizumab administered over 2 years was 1.039 QALY, or a 15.8% average improvement in quality of life for the 12-year life expectancy of the average patient treated for neovascular subfoveal AMD.

The researchers found that the reference case treatment cost was $52,652, and the cost-utility was $50,691 per QALY gained from treatment in the second-eye model.

The first-eye model yielded a 6.4% gain in quality of life, and the cost-utility was $123,887, the authors noted.

However, the combined model yielded a clinically significant 10.4% average gain in quality of life and a cost-utility of $74,169, according to the study, published in the July issue of Ophthalmology.

Endophthalmitis Prophylaxis Crucial After Intravitreal Injection, Surgeon Says

Because of the increasing number of intravitreal injections administered as therapy for various posterior segment diseases, physicians could be facing an emerging epidemic of endophthalmitis if the necessary precautions are not taken, according to one surgeon.

Intravitreal medications often require repeated administration, sometimes as often as once a month. "Patients receive six to 12 injections per year, and potentially, each one of them poses a threat for infection," Terrence P. O'Brien, MD, said at the joint meeting of Ocular Surgery News and the Italian Society of Ophthalmology.

Although the mechanisms of infection are not completely understood, various organisms are normally present on the conjunctival surface, and passing the needle through the conjunctiva and sclera via the pars plana approach may present an opportunity for these organisms to gain entry into the eye. Also, the transient decrease in pressure that is caused by the needle entering the eye may pull the organisms from the tear film and ocular surface inward through the sclerotomy made by the needle, he said.

An additional problem is that intravitreal injections are often administered in an office setting rather than in a surgical theater, where the level of antisepsis is higher and protocols to prevent infections are better defined and stricter.

A panel of experts met recently in the United States to try and provide recommendations on this particular treatment modality, but there was no consensus on a universal routine, Dr. O'Brien said.

"There is a lot of controversy about prevention and pre-injection preparation. Gloves were recognized by everyone to be beneficial, and the use of a sterile lid speculum was recommended. However, there was incomplete agreement about the need for draping the eyelid and lashes," he said.

There was consensus on the use of an antiseptic, namely 10% povidone iodine, for the eyelid and lashes and a drop of 5% povidone iodine placed directly onto the ocular surface.

Antibiotics were another controversial topic, he said, and different opinions were expressed concerning the type, timing and frequency of antibiotic administration before and after the treatment.

The majority said a broad spectrum antibacterial agent such as a fluoroquinolone administered in four consecutive topical doses before the injection and four to six times a day for the first 5 to 7 days after the treatment may be sufficient to protect against the most likely organisms.

However, statistics show that the high rate of endophthalmitis observed in the first studies on intravitreal injections has decreased since new protocols for safety were introduced.

BRVO Patients Improve After Injections Of Anti-VEGF Agent

Pegaptanib appears effective in improving vision and reducing central thickness in patients with branch retinal vein occlusion, according to study results presented in a poster at the annual meeting of the Association for Research in Vision and Ophthalmology.

John J. Wroblewski, MD, and colleagues prospectively evaluated the safety and efficacy of 0.3-mg and 1-mg injections of Macugen (pegaptanib sodium, OSI Eyetech/Pfizer) in treating 20 eyes of 20 patients with macular edema secondary to BRVO. The patients were randomized to receive one of the two doses at six weekly intervals for 12 weeks. After the 12-week point, they were treated on an as-needed basis, according to the poster.

The investigators found that patients had gained an average of 11 letters of visual acuity 1 week after the first injection. Center point thickness decreased by 210 µm, and mean macular volume decreased by 2 mm³.

At 30 weeks, the average gain in vision was 13 letters, the average decrease in center point thickness was 225 µm, and the average decrease in macular volume was 2.3 mm³. Further, nserious adverse ocular events were noted.