Iluvien granted Danish
marketing authorization

Iluvien (fluocinolone acetonide, 190 micrograms) has received marketing authorization from the Danish Health and Medicines Authority for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies, developer Alimera Sciences (Atlanta) said in a news release.

Iluvien is now approved in Austria, France, Germany, Italy, Norway, Portugal, Spain, and the U.K., and is commercially available in Germany and the U.K.

First genetic test to prevent corneal
blindness developed

A group of researchers in Singapore have developed Asia's first genetic test for identifying patients with corneal stromal dystrophy, the group announced.

Called the Polaris TGFBI (Transforming Growth Factor Beta Induced) test, it can also identify family members carrying a TGFBI mutation who may be at risk of developing corneal stromal dystrophy.

The test was developed as part of the Personalized OMIC Lattice for Advanced Research and Improving Stratification (POLARIS) program to translate research findings from Singapore back to Singapore patients. The tool is currently in use at the Singapore National Eye Centre.  

'Cataract backlog-free' zone created in India

A global campaign to eliminate blindness due to cataract has achieved a portion of its mission by eliminating the backlog of patients waiting for cataract surgery in parts of rural India, a group said.

HelpMeSee (New York) along with Sadguru Netra Chikitsalaya and the Shri Sadguru Seva Sangh Trust have worked together over the past 3 years to ensure India's Chitrakoot District, with more than 1 million residents, no longer has a list of people waiting for cataract surgery.

HelpMeSee expects to have a cataract surgical clinic available for every 250,000 people, capable of delivering 2,500 surgeries every year, and plans to replicate the Chitrakoot experience in one district in Uttar Pradesh and one district in Madhya Pradesh by year-end.

Depression common in AMD patients

According to the National Institutes of Health (NIH, Bethesda, Md.), depression is a common risk for people who've lost vision from age-related macular degeneration (AMD); up to 25% of people with bilateral AMD develop clinical depression. However, behavior activation can cut this depression risk in half, NIH said.

Barry Rovner, MD, and colleagues at Thomas Jefferson University (Philadelphia) recruited 188 participants with bilateral AMD into an NIH-funded study on behavior activation. Participants were 84 years of age on average, and 70% were women. Half of the participants lived alone. All had a best corrected vision of less than 20/70. Each had mild depressive symptoms and was considered at risk for developing clinical depression.

Optometrists first evaluated the participants and prescribed low vision devices such as handheld magnifiers. Participants were then randomly split into 2 groups. One received behavior activation. Occupational therapists helped them use the low vision devices, make changes around the home (such as using brighter lights and highlighting objects with high-contrast tape), increase social activities, and set and achieve personal goals by breaking them down into manageable steps. People in the second group met with a support therapist to talk about their vision loss and disability.

Both groups had 6 hour-long therapy sessions in their homes over a 2-month period. They were allowed to take antidepressants, but fewer than 10% did so. By 4 months, 18 in the control group (23.4%) and 11 in the behavior activation group (12.6%) developed clinical depression. Behavior activation had the most benefit for participants with the worst vision (less than 20/100), reducing the risk of depression by about 60% compared to controls. Overall, the researchers estimate that behavior activation reduced the risk of clinical depression by 50% compared to control treatment.

Kala starts p2 study for RVO, DME

Loteprednol etabonate mucus penetrating particle (LE-MPP) platform will begin a phase 2 study in patients with intraretinal or subretinal fluid secondary to retinal vein occlusion or diabetic macular edema, developer Kala Pharmaceuticals (Waltham, Mass.) said in a news release. In addition, Kala has initiated a second phase 2 clinical trial of the same compound in subjects with meibomian gland disease.

In the first study, a single-masked randomized trial, Kala will investigate the efficacy and safety of 1% LE-MPP and 0.25% LE-MPP dosed 4 times daily in patients having measurable intraretinal or subretinal fluid secondary to retinal vein occlusion or diabetic macular edema. Kala aims to enroll up to 20 patients at 2 centers in the U.S.

In the second phase 2, double-masked, randomized trial of LE-MPP, Kala will study the safety and efficacy of 0.25% LE-MPP compared to vehicle dosed 4 times daily in subjects with meibomian gland disease. Kala aims to enroll approximately 150 patients in up to 10 centers in the U.S.

RESEARCH BRIEFS

• J.J. Rixen and T.A. Oetting have developed a modified fishtail technique for inserting capsular tension rings (CTR), they wrote in the Journal of Cataract & Refractive Surgery. A suture line is used to pull the leading eyelet out through the main incision to form the fish configuration. Similar to the fishtail technique, this insertion technique minimizes the risk for zonular damage or a capsule tear because the CTR is not dialed into the capsular bag. The advantage of the suture line is that it prevents over bending of the CTR during insertion through the main incision, which can occur using the traditional fishtail technique.

• The combination of a regenerative agent (RGTA; Cacicol20, OTR3, Paris) with a bandage contact lens (BCL) seems to be an effective treatment for persistent epithelial defects (PEDs), according to a group of researchers. G.D. Kymionis and colleagues reported on 3 patients suffering from a PED for 4-8 weeks who were unresponsive to conventional therapy. They were treated with the combined application of an RGTA (Cacicol20) and a silicone hydrogel BCL. The PED healed in all patients after 4-21 days, and no side effects were noted. The case studies are published in Cornea.

• There is no significant difference in higher order ocular aberrations (HOA) across refractive groups, according to J.A. Little and colleagues. They noted the interaction between HOA and refractive error is not yet fully understood. They evaluated HOAs in two cohorts of Caucasian children aged 9-10 and 15-16 years (n=313). HOAs were measured for a 5 mm pupil with the IRX3 aberrometer (Imagine Eyes, Orsay, France). Cycloplegic refractive error and ocular biometry measures, including axial length and corneal curvature, were also assessed. The magnitude of total HOA was higher in this population at 0.27 μm (inter-quartile range 0.22-0.32 μm) than other HOA reported in the literature. The profile of HOA was not significantly different across the 2 age cohorts or across refractive groups, nor did spherical aberration differ significantly with age (P=0.07 μm for both cohorts). Multivariate linear regression analysis demonstrated spherical aberration was significantly related to axial length (but not refractive grouping), with longer eyes having less positive values of fourth order and RMS spherical aberration. The study is published online ahead of print in Investigative Ophthalmology & Visual Science.

• FCI Ophthalmics (Pembroke, Mass.) introduced a self-retaining bicanaliculus intubation set, designed by Pierre Bigé, MD. Nicknamed the SRSII, the stent allows the physician to intubate the canaliculi in the office with just topical anesthetic drops. The primary indications for the SRSII include horizontal lacrimal duct stricture or punctal stenosis. FCI said special consideration should be given to cancer patients on constricting drug therapies.