Month: February 2013

AMD Update 23: DARPins, The Next “Game Changer” for Wet AMD?

As many of you know, I am now retired and no longer attending ophthalmic industry meetings, the source for much of my writing when I was producing the “Technology Update” columns for Ocular Surgery News for over eleven years. I now scour the web searching for interesting ophthalmic industry news in the field of my current interest –  new technologies for treating retinal diseases, for ideas of stories to write about for this Journal. I also rely on tips from former industry colleagues and new friends that inquire, “Have you heard about…”, which sometimes leads to interesting stories to investigate (Read more...)

New HIPAA/HITECH act omnibus rule: What must be done to comply?

Health care professionals and others working with personal medical information face considerable compliance risks and responsibilities under the omnibus final rule governing “protected health information” (PHI) that the Department of Health and Human Services issued in January 2013 (the Final Rule). The Final Rule sets standards and authorizes substantially increased penalties for violations of HHS’ regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act. Particularly in light of those increased penalties, HIPAA covered entities (Read more...)

Ocular Therapeutix submits premarket approval application for hydrogel sealant

Ocular Therapeutix has submitted a premarket approval application to the U.S. Food and Drug Administration for ReSure sealant, according to a company news release.The sealant, which uses the company’s proprietary hydrogel technology, has the proposed indication of intraoperatively managing clear corneal incisions with a wound leak and preventing fluid egress after cataract surgery or IOL placement, the release said.

NICE issues final guidance supporting the use of ranibizumab for diabetic macular oedema (TA 274)

Source: NICE
Area: Evidence > Guidelines
NICE has issued final guidance (TA 274) supporting the use of ranibizumab for treating visual impairment due to diabetic macular oedema (DMO) only if:
. the eye has a central retinal thickness of 400 micrometres or more at the start of treatment and
. the manufacturer provides ranibizumab with the discount agreed in the patient access scheme (as revised in 2012).
NICE conducted a rapid review of the original guidance (TA 237; November 2011) because the manufacturer submitted a revised Patient Access Scheme, together (Read more...)