The FDA will not approve the investigational drug Iluvien (Alimera and PSividia Corp.) in its present form. Iluvien, an intravitreal insert for the treatment of diabetic macular edema, is an experimental, sustained drug delivery system releasing sub-microgram levels of fluocinolone acetonide. The New Drug Application (NDA) was submitted in June and won priority review for August 2010. It contained 24 months’ worth of safety and efficacy data. The FDA says it now requires 36 months’ of safety and efficacy data, as well as exploratory analyses to properly compare the health costs and benefits of Iluvien. Alimera and pSdivida Corp. reported that they have completed the 36-month study requirement and are working on preparing the analyses.

The patent-pending TheraTears Nutrition (Advanced Vision Research) recently concluded a 36-patient dry eye clinical trial. The results, to be published in Cornea, demonstrate that 70% of patients with dry eye become asymptomatic within three months of treatment, vs. 7% in the placebo group.

The Japanese videogame company Nintendo plans to release a 3DS player in late February, but has issued a warning against use of the device in the 3D mode for children under the age of six. The company indicated a danger to the neural processing that underlies eyesight, which is still developing in young children. The company recommends that children under the age of six switch to the 2D mode instead. Nintendo also recommends that adults who play the 3DS take breaks every 30 minutes.