EW Weekly, March 18, 2016

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March 18, 2016
Volume 21 , Number 11

Allergan receives CRL overnew Restasis formulation

The Food and Drug Administration has sent a complete response letter (CRL) to Allergan (Dublin) on its prior approval supplement for Restasis (topical cyclosporine 0.05%) multi-dose preservative-free (MDPF) presentation, the company said. The FDA requested additional chemistry, manufacturing, and controls (CMC) information for the MDPF bottle, a first of its kind container with patented unidirectional valve and air filter technology, according to a company press release. Allergan plans on responding in a timely manner, and "does not anticipate a significant impact to previously communicated timelines of the potential approval of the MDPF bottle," as no additional data requests accompanied the letter.

SYL1001 for ocular pain related toDES has positive phase 2 results

Two phase 2 dose-finding and efficacy assessment clinical trials of SYL1001 for the treatment of ocular discomfort related to dry eye syndrome (DES) found that 1.125% was an optimal dose to reduce not only ocular pain but also conjunctival hyperemia related to DES, developer Sylentis (Madrid) said in a press release. These randomized, parallel group, double-masked, and placebo-controlled trials took place at 8 centers in Spain and Estonia. A total of 127 patients with ocular pain related to DES enrolled in the 4 dose arm study (0.375%, 0.75%, 1.125% and 2.25%) against placebo following 10 days of once-per-day eye drop administration. SYL1001 is a drug based on RNAi, administered as preservative-free eye drops; it selectively inhibits production of the TRPV1 receptor. These receptors are ion channels that mediate the transmission of ocular pain. SYL1001 is a small synthetic double-stranded RNA oligonucleotide (siRNA) with a novel and highly selective mechanism of action, the company said. Full details will be presented during this year's Association for Research in Vision and Ophthalmology (ARVO) meeting.

Stem cells regenerate human lens

Researchers at the University of California, San Diego School of Medicine and Shiley Eye Institute, with colleagues in China, have developed a new, regenerative medicine approach to remove congenital cataracts in infants, permitting remaining stem cells to regrow functional lenses, the university said in a news release. The treatment, which has been tested in animals and in a small, human clinical trial, produced much fewer surgical complications than the current standard of care and resulted in regenerated lenses with superior visual function in all 12 of the pediatric cataract patients who underwent the surgery.  In the new research, Kang Zhang, MD, and colleagues at the University of California, San Diego relied upon the regenerative potential of endogenous stem cells, stem cells already naturally in place at the site of the injury or problem. In the case of the human eye, lens epithelial stem cells generate replacement lens cells throughout a person's life, although production declines with age. In the 12 infants under the age of 2 treated with the new method and 25 similar infants receiving current standard surgical care, the latter control group experienced a higher incidence of post-surgery inflammation, early-onset ocular hypertension, and increased lens clouding.

Egypt approves Rayner IOLs

The Egyptian Ministry of Health has approved the following IOLs for sale: the C-flex aspheric monofocal IOL range, the Superflex aspheric monofocal IOL range, the T-flex aspheric toric IOL (models 573T and 623T), and the Sulcoflex pseudophakic supplementary aspheric IOL, marketer Rayner (Sussex, U.K.) said on its website.

OIS names Roger Steinert, MD, Lifetime Innovator Award recipient

The Ophthalmology Innovation Summit (OIS) has named Roger Steinert, MD, chair, Department of Ophthalmology, University of California, Irvine, this year's recipient of its Lifetime Innovator Award. "Dr. Steinert's advanced skill and excellent surgical results have earned him a reputation as an international consultant and leader in cataract surgery, refractive surgery and corneal transplants. He has conducted numerous, high-profile research studies and remains at the forefront of innovation developments in refractive surgery," according to a news release. The award is granted to someone for "a lifetime of exceptional contributions to ophthalmic innovation and entrepreneurship," OIS said.

RESEARCH BRIEFS

  • Intraocular collamer lens (ICL) implantation provides good long-term safety and stability of refraction in patients with high myopia, but the rates of cataract formation and ocular hypertension at 10 years have important clinical implications, according to Ivo Guber, MD, and colleagues. They followed 133 eyes of 78 patients undergoing consecutive V4 model ICL implantations, which took place from January 1, 1998, through December 31, 2004, at Jules-Gonin Eye Hospital, Lausanne, Switzerland. During that timeframe, there were 53 V4 model ICLs of -15.5 D or greater, 73 V4 model ICLs of less than -15.5 D, and 7 V4 model toric ICLs for myopia. The rate of lens opacity development was 40.9% and 54.8% at 5 and 10 years, respectively. Phacoemulsification was performed in 5 eyes (4.9%) and 18 eyes (18.3%) at 5 and 10 years after ICL implantation, respectively. The vault height (distance between the posterior ICL surface and anterior lens surface) measured a mean (SD) of 426 (344) μm immediately postoperatively, decreasing to 213 (169) μm at 10 years. A smaller vault height was associated with the development of lens opacity and phacoemulsification (P=.005 and .008, respectively). At 10 years, 12 eyes (12.9%) had developed ocular hypertension that required topical medication. The study is published online ahead of print in JAMA Ophthalmology.
  • Long-term changes in refraction after cataract surgery resulted from natural fluctuations in corneal curvature rather than from IOL position shift, a group of researchers found. S. Klijn and colleagues prospectively enrolled 59 eyes (59 patients) who had routine cataract surgery with implantation of a hydrophobic acrylic 1-piece IOL (AcrySof SA60AT, Alcon, Fort Worth, Texas) in the capsular bag. Refraction was measured with the ARK-530A autorefractor (Marco, Jacksonville, Florida). The IOL position and corneal curvature were measured with the LENSTAR LS-900 biometer (Haag-Streit, Koniz, Switzerland). The median measured absolute refractive change was 0.25 D. The IOL position showed a statistically significant mean posterior shift of 0.033 mm±0.060 between 1 month and 1 year postoperatively (P<.01), of which the median calculated absolute refractive effect was 0.05 D. This did not correlate with the measured refractive shift. Natural fluctuations in corneal curvature caused a median calculated absolute refractive effect of 0.17 D, which correlated well with the measured refractive shift. The study is published in the Journal of Cataract & Refractive Surgery.

NEW PRODUCT BRIEFS

  • Rayner (Sussex, U.K.) introduced a new ophthalmic viscosurgical device, Ophteis FR Pro, a "uniquely bio-engineered OVD containing sorbitol, added at 4% concentration to the 2% NaHA," the company announced. Sorbitol is a "highly stable antioxidant molecule, found naturally in the aqueous humor. When combined in Ophteis FR Pro, sorbitol has a neutralizing or 'scavenging' effect on free radicals, enabling a new level of corneal endothelial protection from phaco induced trauma," the company said.
  • HelpMeSee (New York) launched a "comprehensive effort to identify and eliminate cases of pediatric cataract blindness in Peru," the company said. The joint project with HelpMeSee, Instituto Damos Vision and the U.S. Agency for International Development (USAID) Child Blindness Program will expand screening and care for children affected by cataract blindness. Outreach and screening technologies developed by HelpMeSee will be used for the first time in Peru to assist community health agents and facilitate access to care. These include HelpMeSee Reach, a smartphone app that includes a Global Positioning and Patient Information System and integrates with Google's Android platform to improve health evaluation and screening. 

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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