Author: Healio ophthalmology

BLOG: In treating glaucoma, don’t forget old-fashioned clinical skill

The cover story in the current issue of Ocular Surgery News focuses on the progression of glaucoma, one of our field’s most perplexing mysteries. The longer I practice ophthalmology, the less certain I have become that we really understand glaucoma. Sure, I can follow accepted standards of care, setting target pressures and assessing regularly for compliance and efficacy, but I feel less and less like we really know what’s going on, especially with the enigmas we call low-tension glaucoma and ocular hypertension.

Stakes enormous as Supreme Court weighs ‘pay-to-delay’ generic drug deals

From international law firm Arnold & Porter LLP comes timely views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.The Supreme Court is poised to resolve a long-running debate regarding the legality of so-called “reverse payment” patent litigation settlements between brand drug and generic drug companies. The court heard oral argument on March 25 in FTC v. Actavis, a case that focuses on these settlements, in which (1) the brand company licenses the generic product to enter the market on a certain date, typically years before the brand’s patent expires; and (2) the brand company gives the generic company something else of value, be it a cash payment, a license on another product, or some type of fee-for-service business arrangement.

Force gauge used to test integrity of clear corneal incisions

A calibrated force gauge was used to apply pressure approximating what a patient’s eye might experience when it is rubbed, and then that pressure was used to determine the rate of wound leak after clear corneal incision cataract surgery.The study authors used the Dontrix gauge (GAC International), modified by Ocular Therapeutix, to determine a force of 1 oz was needed to approximate patient manipulation of the eye. The instrument can be sterilized and used to provide a controlled, quantifiable amount of force, the authors said.

HHS fraud alert targets physician-owned distributorships

Physician-owned distributorships are the target of a new special fraud alert issued by the Office of Inspector General.Citing the “strong potential for improper inducements between and among the physician investors, the entities, device vendors and device purchasers,” the alert, dated March 26, sounded a clear warning about how the office views physician-owned distributorships (PODs).“We believe that PODs are inherently suspect under the anti-kickback statute,” the alert said, adding that the office is concerned about the “proliferation” of PODs.

Age, refractive index of corneal stroma help improve LASIK predicted outcomes

Factoring patient age and refractive index of the corneal stroma into the treatment profile improved the predictability of LASIK outcomes, according to a study.The prospective study included 133 eyes, of which 107 were myopic and 26 were hyperopic. Mean patient age was 33.4 years. Mean refractive index was 1.368, and attempted spherical correction was –2.43 D.

Rayner IOLs approved for sale in Mexico, Thailand

Rayner Intraocular Lenses has received regulatory approval to begin selling some products in Thailand and Mexico, according to a company news release.In Thailand, all of Rayner’s hydrophilic acrylic lenses — C-flex, C-flex aspheric, Superflex, Superflex aspheric, T-flex aspheric, M-flex, M-flex T, Sulcoflex aspheric, Sulcoflex toric, Sulcoflex multifocal and Sulcoflex multifocal toric — were approved, along with Raysert, a small-incision injector.

Milestone payment improves 2012 revenue, net loss at Nicox

Nicox recorded revenue of €7.6 million in 2012 after recording no revenue in 2011, according to a company news release. The revenue increase was largely related to a $10 million milestone payment from Bausch + Lomb, which opted to continue developing latanoprostene bunod, a glaucoma drug candidate. As a result, there was a net loss of €10.2 million in 2012 compared with a net loss of €16.6 million in 2011.

Clinical Specialties recalls Avastin unit dose syringes

Clinical Specialties Compounding Pharmacy has voluntarily issued a nationwide recall of Avastin unit dose syringes after it received five reports of intraocular infections, according to a press release from the U.S. Food and Drug Administration. The recall covers 79 lots of Avastin (bevacizumab, Genentech) distributed to physicians’ offices in Georgia, Louisiana, South Carolina and Indiana from Dec. 18, 2012, to the present, the release said.