Author: Healio ophthalmology

Allegro continues studies of integrin peptide therapy

Allegro Ophthalmics has completed enrollment of a phase 1b/2a study of the impact of its integrin peptide therapy on wet age-related macular degeneration, according to a company news release. In addition, Allegro has begun a second study of the therapy’s impact on diabetic macular edema.Safety is the primary endpoint of the dose-ranging, monotherapy wet AMD study of ALG-1001, with secondary endpoints of improvement in central macular thickness and best corrected visual acuity.

IOP-lowering effect of excimer laser trabeculostomy stable over long term

SAN FRANCISCO — Excimer laser trabeculostomy is an effective IOP-lowering procedure, shown to consistently lower IOP over 5 years, according to a poster presented at the American Glaucoma Society annual meeting.”ELT is a MIGS procedure requiring no foreign body implantation,” poster coauthor Michael S. Berlin, MD, told Ocular Surgery News. The study findings are significant, he said, because the results are achieved with excimer laser trabeculostomy (ELT) alone, not combined with cataract surgery.

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 (health plans, health care clearinghouses, and most health care providers) and their “business associates” — which are now directly subject to HHS regulations — should be actively reviewing their new responsibilities under the Final Rule.

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.

Carl Zeiss Meditec introduces data management options for Forum system

Carl Zeiss Meditec has announced the release of new management software and a glaucoma management application to expand the offerings of its Forum eye care data management system.The Forum Glaucoma Workplace will allow physicians to combine Cirrus optical coherence tomography and Humphrey Field Analyzer perimetry information and interactively review patients’ visual field data, according to a news release.

Eylea drives increase in net income for Regeneron

Regeneron Pharmaceuticals reported a net income of $750.3 million in 2012, compared with a net loss of $221.8 million in 2011, according to a company press release.Revenues increased from $445.8 million in 2011 to $1.4 billion in 2012. Eylea (aflibercept) accounted for $838 million in U.S. net sales in 2012, leading to Regeneron’s first full year of profitability, according to the release.

Intracorneal ring segments may not halt progressive keratoconus in long term

WARSAW, Poland — Implantation of intracorneal ring segments in young keratoconus patients may not be able to stop the progressive nature of the disease, even though it may provided a significant short-term improvement in visual, refractive and topographic status, according to one surgeon.”Several studies have shown the efficacy of this procedure in improving [visual acuity] and flattening the central cornea. However, there is no scientific data to support that corneal ring segment implantation can halt the progressive nature of the disease,” Alfredo Vega-Estrada, MD, said at the winter meeting of the European Society of Cataract and Refractive Surgeons.