KalVista initiates phase 1 DME study

A novel plasma kallikrein inhibitor, KVD001, has entered U.S. phase 1, first-in-human studies, developer KalVista (Southampton, U.K.) said in a news release. The study is an open label, single ascending dose study to investigate the safety, tolerability, and pharmacodynamics of KVD001 delivered by intravitreal injection. The first patients were dosed this month, and recruitment is ongoing at 5 centers in the U.S., the company added.

Plasma kallikrein is a serine protease that has been shown to contribute to blood vessel leakage and thickening of the retina. The detrimental effects of plasma kallikrein on the retina in patients with diabetes are mediated by mechanisms that are independent of vascular endothelial growth factor, KalVista said.

KeraMed to license endothelial graft
insertion technology

KeraMed (Sunnyvale, Calif.) will license its proprietary double coil no-touch technology for endothelial graft insertion to four companies: Network Medical Products, Coronet Medical Technologies, Angiotech Pharmaceuticals, and Surgical Specialties Corp., the company announced.

KeraMed's technology was invented by Yichieh Shiuey, MD, and allows the insertion of Descemet's stripping endothelial keratoplasty grafts through incisions as small as 3.5 mm, the company said.

Germany to reimburse for RP treatment

The Alpha IMS chip, a subretinal implant for patients blinded by retinitis pigmentosa, has been granted NUB innovation status in Germany and will now be reimbursed, developer Retina Implant (Reutlingen, Germany) said in a news release.

The device is implanted beneath the retina in the macular region and simulates the functioning nerve cells of the eye. In the 42 patients implanted to date, postoperatively they were able to distinguish objects such as telephones, cups, and plates, the company noted. 

New eyecare hub to serve 10%
of Mozambique's population

A new clinic in Beira, Mozambique, will serve as an eyecare hub for more than 2 million patients, or about 10% of the country's population, local sources said. According to Ventures Africa, the Invicta Eye Clinic will be fitted with capacity to treat 25,000 patients and perform 1,200 surgeries per year.

The eye clinic will also house training facilities that will be used in addressing the shortage of professionals in the country where just 18 ophthalmologists and 54 ophthalmic nurses serve about 23 million people, or about 1 ophthalmologist per 1.3 million patients.

African Americans at higher risk for diabetic vision loss

Research by scientists from Keck School of Medicine, University of Southern California (USC), Los Angeles, concluded African Americans bear heavier burden of diabetic macular edema (DME), the university said in a news release.

The research published online in JAMA Ophthalmology indicated a higher burden of diabetes-related vision loss among certain ethnic populations because of problems with access to care, said corresponding author Rohit Varma, MD, director of the USC Eye Institute and professor and chair of ophthalmology at the Keck School of Medicine.

Dr. Varma said it was "surprising" that African Americans have the highest rates of DME, as Hispanics tend to have the highest prevalence of diabetes. 

Joint CL microbiology workshop aimed at preventing keratitis

A contact lens (CL) microbiology workshop scheduled for Sept. 12, 2014, at a Food and Drug Administration campus, will attempt to find additional means of preventing Acanthamoeba keratitis in CL wearers. The Centers for Disease Control and Prevention and the FDA issued a patient alert about Acanthamoeba keratitis in 2007 after 138 cases emerged following sales of a new multipurpose CL solution that was then recalled by the manufacturer. The infections created a growing concern over the organism and how to test for its presence in contact lens products. Today there remains no required standardized test method for disinfection efficacy against microbes like Acanthamoeba in contact lens products.

The event is jointly sponsored by the FDA, the Contact Lens Association of Ophthalmologists, the American Academy of Ophthalmology, the American Academy of Optometry, and the American Optometric Association.

RESEARCH BRIEFS

• In an ongoing, prospective, multicenter, randomized, placebo-controlled trial evaluating the adjuvant use of intravitreal dexamethasone in the treatment of patients with suspected bacterial endophthalmitis after phacoemulsification, initial interim results compare favorably to those in the published literature, according to E.W. Lindstedt and colleagues. A total of 81 patients with suspected endophthalmitis after phacoemulsification were given intravitreal injections of 400 micrograms of dexamethasone or a placebo, plus 0.2 mg vancomycin and 0.05 mg gentamicin. Injections were repeated after 3 or 4 days. After at least 1 year of follow-up, 63 patients (65%) were culture-positive. Seven eyes were eviscerated (3 dexamethasone, 4 placebo); 4 eyes had no light perception (2 dexamethasone, 2 placebo); and 4 eyes had less than 5/200 vision (3 dexamethasone, 1 placebo). A total of 70% of patients had a visual acuity of at least 20/40. The study is published online ahead of print in Graefe's Archives of Clinical and Experimental Ophthalmology.
• Although eliminating multiple intraocular pressure (IOP) measurements would simplify the conduct of surgical trials in glaucoma, new data show that using a single IOP measurement after washout does not adequately approximate the mean of multiple IOP measurements. L. Zhang and colleagues conducted a prospective, multicenter, interventional cohort from the pre-randomization phase of a clinical trial evaluating use of a supraciliary implant for treatment of IOP. A total of 609 patients (609 eyes) with primary open-angle glaucoma and cataract were included. One IOP measurement was made while patients were receiving their usual medications to lower IOP, and 3 IOP measurements were made at 8 a.m., 12 p.m., and 4 p.m. after patients underwent washout of all IOP-lowering eye drops. The mean (SD) IOP before washout was 18.5 (4.0) mmHg. The mean increase in IOP after washout, using the mean of 3 measurements, was 5.3 (4.2) mmHg. The percentage of eyes in which the increase in IOP using a single post-washout IOP differed from the increase in IOP using the mean of 3 measurements by more than 1.5 mmHg was 35.1%, 25.6%, 34.2%, 30.0%, and 31.4% when the single measurement was made at 8 a.m., 12 p.m., 4 p.m., a randomly chosen single measure of those 3 times, and the time closest to that of the pre-washout IOP, respectively. The study is published in JAMA Ophthalmology.
• Long-term data indicate that refractive lenticule extraction is an effective and safe procedure for the treatment of myopia and myopic astigmatism and has excellent stability. Marcus Blum, MD, and colleagues evaluated the 5-year results of femtosecond laser-assisted refractive lenticule extraction (ReLEx FLEx) for the treatment of myopia and myopic astigmatism on 41 of the original 108 study eyes that reached the 5-year mark. At 5 years, 100% of eyes were within ±1.00 D of the intended correction and 73% were within ±0.50 D. By 5 years, no eye had lost 2 or more Snellen lines and 1 eye had lost 1 Snellen line. The mean regression was 0.07 D. The study is published in the Journal of Cataract & Refractive Surgery. 

Important Safety Information - TECNIS® Toric IOL

Indications: The TECNIS® Toric 1-Piece posterior chamber lenses are indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.

Warnings: Physicians considering lens implantation should weigh the potential risk/benefit ratio for any circumstances described in the TECNIS® Toric 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. The clinical study did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one diopter. The TECNIS® Toric 1-Piece IOL should not be placed in the ciliary sulcus. Rotation of the TECNIS® Toric 1-Piece IOL away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder.

Precautions: Accurate keratometry and biometry in addition to the use of the TECNIS Toric Calculator (www.TECNISToricCalc.com) are recommended to achieve optimal visual outcomes. The safety and effectiveness of the toric intraocular lens have not been substantiated in patients with certain preexisting ocular conditions and intraoperative complications. Refer to the TECNIS® Toric 1-Piece IOL Directions for Use for a complete description of the preexisting conditions and intraoperative complications. All preoperative surgical parameters are important when choosing a toric lens for implantation. Variability in any of the preoperative measurements can influence patient outcomes. All corneal incisions were placed temporally in the clinical study. Do not reuse, resterilize, or autoclave.

Adverse Events: The most frequently reported adverse event that occurred with the TECNIS® Toric 1-Piece IOL was surgical reintervention, which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures). Other reported events included macular edema, which occurred at a rate of 2.9% and retinal detachment which, occurred at a rate of 0.6%.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Attention: Reference the Directions for Use labeling for a complete listing of Indications, Warnings and Precautions.

TECNIS is a trademark owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates.

©2013 Abbott Medical Optics Inc.  www.AbbottMedicalOptics.com

2013.03.08-CT6527