Dextenza (sustained release dexamethasone, Ocular Therapeutix, Bedford, Massachusetts) intracanalicular depot for the treatment of ocular itching associated with chronic allergic conjunctivitis failed to meet its primary endpoint for ocular itching, the company said in a press release. While mean ocular itching was seen to be numerically lower (more favorable) in the Dextenza treatment group compared to the placebo group measured 7 days following insertion of the depots, at 3, 5, and 7 minutes by -0.18, -0.29, and -0.29 units, respectively, on a 5-point scale, this difference did not reach statistical significance. In addition, the trial did not achieve the requirement of at least a 0.5-unit difference at all 3 time points 7 days following insertion of the depots and at least a 1.0-unit difference at the majority of the 3 time points between the treatment group and the placebo group 7 days following insertion of the depots. The results from this phase 3 trial contrast with those achieved in the first phase 3 clinical trial completed last year, where Dextenza met the primary endpoint, with mean ocular itching scores being lower in the Dextenza group at 3, 5, and 7 minutes by -1.02, -0.87, and -1.04 units, respectively (p<0.0001), 7 days following insertion of the depots. The company plans an in-depth analysis to determine the differences in the 2 study cohorts that led to the differences in outcomes. The company is awaiting a decision from the Food and Drug Administration on Dextenza for the treatment of post-surgical ocular pain; a decision is expected next month.

According to the Prevent Blindness "Future of Vision: Forecasting the Prevalence and Costs of Vision Problems," the current number of those in the U.S. with cataract will increase from more than 25.7 million to 38.5 million by 2032, and then to 45.6 million by the year 2050. The Chicago-based organization also noted the World Health Organization has named cataract the world's leading cause of blindness, the group said in its newsletter. Prevent Blindness has declared June as Cataract Awareness Month to educate the public on risk factors, symptoms and treatment options, including surgery.

A phase 3 study on Actemra (tocilizumab) found the study drug more effectively sustained remission through 1 year compared to a 6- or 12-month steroid-only regimen in people with newly diagnosed and relapsing giant cell arteritis (GCA), developer Genentech (South San Francisco) said in a news release. Actemra is initially combined with a 6-month steroid (glucocorticoid) regimen, Genentech added. No new safety signals were observed with Actemra, and adverse events were similar to those seen in previous clinical studies. The study is a phase 3, global, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Actemra as a novel treatment for GCA. It is the largest clinical trial ever conducted in GCA and the first to use masked, variable-dose, variable-duration steroid regimens. The multicenter study was conducted in 251 patients across 76 sites in 14 countries. The study's primary and key secondary endpoints were evaluated at 52 weeks.

A University of Wisconsin-Madison research team has discovered novel genetic mutations that are responsible for primary congenital glaucoma (PCG), the university said in a news release. The researchers found that a key cell membrane receptor protein (known as TEK) is necessary for proper development of Schlemm's canal. "The TEK gene plays an essential role in eye health, and individuals carrying a mutation in this gene are at a much higher risk of developing newborn or later-onset forms of glaucoma," Terri Young, MD, chair of the Department of Ophthalmology and Visual Sciences, said in the release. Mutations in the CYP1B1 gene are the most common cause of PCG in families with a high degree of marriage between relatives. However, it is a much less common cause in ethnically diverse populations, Dr. Young said. The team recruited families with at least 1 child with PCG, and identified 10 families that had mutations in the TEK gene. One family also had a parent with a diagnosis of childhood glaucoma, and another family contained several individuals with later-onset forms of the disease.

The European Commission has granted an orphan medicinal product designation to an investigational gene therapy product candidate for the treatment of X-linked retinitis pigmentosa (XLRP) caused by mutations in the RPGR gene, developer Applied Genetic Technologies Corporation (Gainesville, Florida) said in a news release. The Food and Drug Administration had previously granted orphan drug designation to the therapy, the company said. XLRP is an inherited condition that causes progressive vision loss, beginning with night blindness in young boys followed by progressive constriction of the field of vision. Affected men become legally blind at an average of about 45 years of age. The most common form of XLRP is caused by mutations in the RPGR gene. Preclinical data indicate that treatment with a gene therapy product slowed the loss of visual function in canines with XLRP caused by mutations in the RPGR gene.