Victus receives 510(k) clearance

for lens fragmentation 

Bausch + Lomb (Rochester, N.Y.) has received 510(k) clearance from the Food and Drug Administration for its Victus Femtosecond Laser Platform for laser-assisted lens fragmentation during cataract surgery, the company announced.

The Victus platform offers a number of different lens fragmentation patterns depending on the cataract grade and user preference, the company said.

The Victus now has U.S. regulatory clearance for the creation of a corneal flap in patients undergoing LASIK surgery, anterior capsulotomy during cataract surgery, penetrating arcuate cuts/incisions in the cornea, and laser-assisted lens fragmentation during cataract surgery.

Alcon to license Google

"smart lens" technology

Alcon (Ft. Worth, Texas) will in-license Google's "smart lens" technology for all ocular medical uses, the company said in a news release.

The smart lens technology involves non-invasive sensors, microchips, and other miniaturized electronics that are embedded within contact lenses. Basel, Switzerland-based Novartis' interest in this technology is currently focused in two areas: First, helping diabetic patients manage their disease by providing a continuous, minimally invasive measurement of the body's glucose levels via a "smart contact lens," which is designed to measure tear fluid in the eye and connects wirelessly with a mobile device. Second, the technology has the potential to provide accommodative vision correction for presbyopes.

BioLight granted patent for long-term controlled-release drug delivery platform

BioLight Israeli Life Sciences Investments (Tel Aviv) has been issued a patent in the U.S. for a "device that is inserted into the eye to treat an ocular condition that contains an active agent of a free acid salt form of a prostaglandin with a low elution rate profile that is contained in the long-term controlled-release insert platform," the company said. The patent covers the technology used in Eye-D, the company's controlled-release latanoprost insert currently in a Phase 1/2a clinical study in the U.S. for the treatment of glaucoma.

Bascom Palmer, Wills Eye ranked

1-2 as nation's best

For the 11th consecutive year, Bascom Palmer Eye Institute (BPEI, Miami) has been ranked the nation's best in ophthalmology by U.S. News & World Report, BPEI officials said in a news release. 

Wills Eye Hospital (Philadelphia) was ranked No. 2, and has spent 25 years in the top-tier rankings of the magazine, officials said in
the release. 

RestorGenex raises $35.6 million 

RestorGenex Corporation (Chicago) has closed a private placement that raised close to $35.6 million in gross proceeds, the company said. Part of the proceeds will be used to fund the company's early stage platform that inhibits the PI3K/Akt/mTOR pathway and is a potential target in the treatment of age-related macular degeneration (AMD), the company said.

AMD, low vision, depression linked

The first clinical trial to examine integrated low vision and mental health treatment has shown that the approach can reduce the incidence of depression by half among people with low vision due to AMD, according to the American Academy of Ophthalmology (San Francisco, Calif.)

The 2013 Low VIsion Depression Prevention TriAL (VITAL) first provided each participant with 2 sessions of outpatient low vision optometric rehabilitation in clinics. Then the patients were randomly assigned to two types of psychological therapy: either six 1-hour sessions of in-home behavior activation over 8 weeks or six 1-hour sessions of in-home supportive therapy over 8 weeks, which served as a control.

After 4 months, the researchers assessed 8 variables, including depression, vision status, vision-related quality of life, physical health status, and device use, and found that the incidence of depressive disorders was half in the behavior activation group than of that in the supportive therapy group (12.6% versus 23.7%, respectively). The rate of depression found in the supportive therapy group was also similar to that reported in the absence of any treatment.

The risk reduction was strongest in participants with worse vision than in participants with better vision (20% versus 3.4%, respectively). In addition, behavior activation was associated with improved near functional vision, but the difference between the two groups was not statistically different. The researchers also found that participants who self-rated their own health lower were associated with a higher incidence of depression regardless of the treatment used, indicating that those with worse health perceptions require more intensive intervention.

RESEARCH BRIEFS

• The number of people with glaucoma worldwide will increase to 111.8 million in 2040, disproportionally affecting people residing in Asia and Africa, new research from Y.C. Tham and colleagues shows. These estimates are important in guiding the designs of glaucoma screening, treatment, and related public health strategies. The group systematically examined the global prevalence of primary open-angle glaucoma (POAG) and primary angle-closure glaucoma (PACG), and projected the number of affected people in 2020 and 2040. The global prevalence of glaucoma for population aged 40-80 years is 3.54%. The prevalence of POAG is highest in Africa, and the prevalence of PACG is highest in Asia. In 2013, the number of people (aged 40-80 years) with glaucoma worldwide was estimated to be 64.3 million, increasing to 76.0 million in 2020 and 111.8 million in 2040. In the Bayesian meta-regression model, men were more likely to have POAG than women, and after adjusting for age, gender, habitation type, response rate, and year of study, people of African ancestry were more likely to have POAG than people of European ancestry, and people living in urban areas were more likely to have POAG than those in rural areas. The study is published online ahead of print in Ophthalmology.
• Toric implantable collamer lens (TICL) implantation after sequential intracorneal ring segments (ICRS) implantation and corneal collagen UVA crosslinking (CXL) is an effective and safe option for correcting high residual refractive error and improving visual acuity in patients with moderate to severe keratoconus, according to A. Dirani and colleagues. The retrospective study examined the results of a 3-step ICRS-CXL-TICL in 11 eyes of 7 patients with moderate to severe keratoconus. The 2 procedures (ICRS-CXL) were performed sequentially at an interval of 4 weeks and TICL implantation was performed at least 6 months after CXL. Data were collected preoperatively, at the 6-month follow-up visit after sequential ICRS-CXL, and at the 6-month follow-up visit after TICL implantation. The ICRS-CXL induced a significant decrease in keratometry, increase in visual acuity, and decrease in refraction. At 6-month follow-up after ICRS-CXL, mean Kflat was 45.19 ± 3.98 D vs 48.51 ± 4.26 D preoperatively (P = 0.022) and mean Ksteep was 50.41 ± 4.32 D vs 54.24 ± 4.96 D preoperatively (P = 0.032). Uncorrected distance visual acuity significantly improved from 1.47 ± 0.38 logMAR before ICRS-CXL to 0.27 ± 0.20 logMAR 6 months after (P = 0.002). Corrected distance visual acuity significantly improved from 0.50 ± 0.22 logMAR to 0.29 ± 0.23 logMAR (P = 0.001). No intraoperative or postoperative complications occurred. The study is published in the European Journal of Ophthalmology.
• Light-adjustable IOL (LAL) implantation achieved accurate refractive outcomes (around emmetropia) with good uncorrected distance visual acuity, which remained stable over time, a Spanish study has found. E.A. Villegas and colleagues treated 53 eyes (49 patients) with an LAL and estimated the effective changes in refraction by subtracting those in the whole eye and the cornea, which were measured with a Hartmann-Shack sensor and a corneal topographer, respectively. Follow-up was at 3-, 6-, and 12-months. Each tested light spatial pattern (5 spherical; 3 astigmatic) produced a different refractive change (P<.01). The combination of 2 light adjustments induced a maximum change in spherical power of the light-adjustable IOL of between -1.98 diopters (D) and +2.30 D and in astigmatism of up to -2.68 D with axis errors below 9° degrees. The 2 required lock-in procedures induced a small myopic shift (range +0.01 to +0.57 D) that depended on previous adjustments. The study is published in the Journal of Cataract & Refractive Surgery.

• Bausch + Lomb (Rochester, N.Y.) has introduced Soothe Xtra Protection (XP) eye drops with Restoryl, a "unique emulsion system featuring a proprietary blend of mineral oils and interfacial molecules," the company said. The eye drops target the main source of dry eye symptoms by replenishing the lipid layer of the tear film.

• Zoomax (San Francisco, Calif.) has introduced Panda, a 19-inch desktop electronic magnifier, for people with visual impairments, the company said. Three large, intuitive buttons control brightness, color modes, and zoom level, making it easy to learn,
  Zoomax said. 

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