Author: Healio ophthalmology

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.

EyeTechCare raises €10 million to advance trial of ultrasound glaucoma device

EyeTechCare has completed a third round of funding, raising €10 million for an international clinical trial and the U.S. Food and Drug Administration registration process, according to a company news release.After the EyeMUST 1 trial on the EyeOP1 device, which involved about 60 glaucoma patients in France, EyeTechCare received a CE mark in May 2011 to begin marketing, sales and distribution activities for the noninvasive, ultrasound device, the release said.