EW Weekly, September 16, 2016

September 16, 2016
Volume 21 , Number 33

FDA approves laser for SMILE procedure

The U.S. Food and Drug Administration (FDA) approved the VisuMax Femtosecond Laser (Carl Zeiss Meditec, Jena, Germany) for the small incision lenticule extraction (SMILE) procedure to reduce or eliminate nearsightedness in certain patients 22 years of age or older, according to an FDA press release. The laser makes cuts within the cornea, creating a disc-shaped piece of tissue that is removed by the surgeon through a small incision in the surface of the cornea. This tissue removal causes the shape of the cornea to change, correcting nearsightedness. A clinical study of the safety and effectiveness of the device to correct nearsightedness found the procedure resulted in stable vision correction at 6 months. Of the 328 participants evaluated at 6 months, all but one had uncorrected visual acuity of 20/40 or better, and 88% had uncorrected visual acuity of 20/20 or better.

Pixium Vision receives clinical trial approval from Spanish Ministry of Health

Pixium Vision (Paris) announced via press release that it has received approval from the Spanish Ministry of Health for a clinical trial of the IRIS II bionic vision system for patients who have lost sight due to retinitis pigmentosa. The IRIS II system features a mini bio-inspired camera and a 150-electrode epi-retinal implant with an explantable design. In July 2016, Pixium Vision received EU market approval for IRIS II. The bio-inspired camera is intended to mimic the functioning of the human eye by continuously capturing the changes in a visual scene with its time independent pixels. The IRIS II clinical trial is a multi-centric, open-label, non-randomized prospective European study to assess safety and performance of the IRIS II bionic vision system as treatment to compensate for blindness, providing a form of perception for blind people and enabling them greater autonomy and quality of living.

Lonza will offer novel Anc-AAV gene therapy technology through licensing agreement with Massachusetts Eye and Ear

Lonza Houston and Massachusetts Eye and Ear have entered into a strategic agreement that provides customers the ability to in-license Anc80 and other Anc-AAVs for the clinical development and commercialization of novel gene therapies, according to a press release. The goal is to accelerate gene therapy drug development across the field. Anc-AAVs, silico-designed synthetic adeno-associated viral vectors (AAVs), were developed first in the laboratory of Dr. Luk Vandenberghe, assistant professor at Harvard Medical School, and director of the Grousbeck Gene Therapy Center at Massachusetts Eye and Ear. The agreement will also include the initiation of an innovative platform development effort aimed at discovering additional next generation Anc-AAVs. Lonza will work toward the establishment of modern best-in-class large-scale manufacturing platforms for Anc80 and any future vectors generated out of Dr. Vandenberghe's laboratory. Under the agreement, Lonza will fund research at the Grousbeck Gene Therapy Center at Massachusetts Eye and Ear to "discover, characterize, and develop next-generation gene transfer reagents in order to improve upon important limitations of current AAVs, including pre-existing immunity, manufacturing yields, immunogenicity, tissue tropism, and specificity," according to the press release. Additionally, Massachusetts Eye and Ear will grant Lonza the exclusive position to commercially license Anc-AAV while it retains certain commercial and academic rights.

Research briefs

  • The estimated prevalence of noninfectious uveitis (NIU) was found to be 121 cases per 100,000 for adults and 29 per 100,000 for children, in a study conducted by Jennifer Thorne, MD, and colleagues. The aim was to estimate NIU prevalence using a large, retrospective, administrative claims database in the U.S. Prevalence was estimated using administrative claims from a commercially insured population, which may have a different prevalence than other segments of the U.S. population. A better understanding of the prevalence of NIU will help to determine the number of patients affected. This collection of intraocular inflammatory disorders may be associated with significant visual impairment, according to the study, and few studies have investigated NIU prevalence overall or stratified by inflammation location, severity, presence of systemic conditions, age, or sex. The analysis used a large database to estimate 2012 NIU prevalence, with analysis conducted in September 2016. The study included patients with NIU with two or more uveitis diagnoses on separate days in 2012 and continuous enrollment in a health plan for all of 2012 and categorized by inflammation site. Of the approximately 4 million eligible adult patients, approximately 2.1 million were women, and of the 932,260 children, 475,481 were boys. In addition to the prevalence in both adults and children, anterior NIU accounted for 81% of adult NIU cases and 75% of pediatric NIU cases. Additionally, it was found that the prevalence of NIU increased with age and was higher among adult females than males. Application of these estimates to the U.S. population suggests that NIU affected approximately 298,801 American adults and 21,879 children in 2015. The study was published online first in JAMA Ophthalmology.
  • Early Descemet's stripping endothelial keratoplasty (DSEK) for pseudophakic corneal edema appears to be associated with improved vision, according to a study conducted to determine the influence of early DSEK on outcomes in patients with pseudophakic corneal edema. The study, conducted by Sarah Weissbart, MD, and colleagues, used a cohort study of 120 eyes of patients who underwent DSEK for corneal edema following cataract surgery (CE). In the study, 87% of eyes had a diagnosis of Fuchs' dystrophy. Post-DSEK visual acuity was compared in patients who underwent DSEK ≤6 months versus >6 months after CE. Additionally, linear and logistic regression were performed to assess the relationships between DSEK timing and best spectacle corrected visual acuity (BSCVA) while accounting for baseline preoperative patient characteristics. Postoperative best corrected visual acuity 6 months after DSEK (POM6 BSCVA) was measured. According to the study's abstract, the median CE-DSEK time was 8.62 months (n=120). Overall median preoperative VA and POM6 BSCVA were 0.54 and 0.24, respectively. Median POM6 BSCVA was better in patients with CE-to-DSEK time ≤6 months (median 0.18) versus >6 months (median 0.30) (p=0.014). A significant relationship was found between CE-to-DSEK time and POM6 BSCVA (coefficient=0.002, p=0.033), accounting for preoperative vision and pachymetry. Patients who underwent DSEK ≤6 months after CE were more likely to achieve POM6 BSCVA better than 20/40 (OR=3.73, p=0.035). Even though the study indicated that early DSEK appears to be associated with improved vision in these patients, it also determined that further prospective study is warranted to determine the optimal time to perform DSEK in patients with pseudophakic corneal edema. The study was published online first in the American Journal of Ophthalmology.
  • During a short-term accommodation process, corneal volume was the only corneal parameter to change in a study analyzing the effect of accommodation on the anterior segment data (including corneal and anterior chamber parameters) induced by short-time reading in a healthy, non-presbyopia adult patient group. The study showed some fine changes with accommodation of the cornea in young, emmetropic patients. Additionally, the position of the pupil and the anterior chamber parameters were observed to change with accommodation as captured by a Scheimpflug device. The study, by Agnes Lipecz and colleagues,took images of both eyes of non-presbyopia volunteers using a Scheimpflug device (Pentacam HR, Oculus, Arlington, Washington) in a non-accommodative state. Then there was a 15-minute reading period, and through fixation of the built-in target of Pentacam HR, further accommodation was achieved and new images were captured by the device. Anterior segment parameters were observed and the differences were analyzed. In the study, 52 eyes of 26 subjects were included. There were no significant differences found in the keratometric values before and after the accommodative task (p=0.35). A statistically significant difference was measured in the 5.0-mm diameter and the 7.0-mm diameter corneal volume (p=0.01 and p=0.03) between accommodation states. Corneal aberrometric data did not change significantly during short-term accommodation. Significant differences were observed between non-accommodative and accommodative states of the eyes for all measured anterior chamber parameters. The study was published online first in the European Journal of Ophthalmology.

EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Eric Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara Chan, MD, cornea editor; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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