EW Weekly, September 21, 2018

September 21, 2018
Volume 24 , Number 35

Xelpros approved by FDA for elevated IOP in open angle glaucoma

The U.S. Food and Drug Administration (FDA) has approved Xelpros 0.005% (latanoprost ophthalmic solution, Sun Pharma, Mumbai, India, and SPARC, Princeton, New Jersey) to lower IOP in patients with open angle glaucoma or ocular hypertension. Sun Pharma in-licensed Xelpros from SPARC in June 2015. Xelpros is the first and only form of latanoprost not formulated with benzalkonium chloride, according to a press release from the two companies. It is developed using SPARC's proprietary Swollen Micelle Microemulsion technology. The recommended dosage for Xelpros is one drop in the affected eye once a day in the evening.

FDA approves PMA supplement of the Visian Toric ICL for myopia with astigmatism

The FDA has given approval of the PMA supplement for the Visian Toric Implantable Collamer Lens (ICL, STAAR Surgical, Monrovia, California) to correct myopia with astigmatism. This expands the ICL's product line to correct refractive error in patients with myopia and astigmatism, according to a STAAR press release. Company leaders plan to make the Visian Toric ICL available in the U.S. on November 1.

Rare pediatric disease status granted to LBS-008 for Stargardt disease

The FDA has granted rare pediatric disease status to LBS-008, a first-in-class oral therapy to treat Stargardt disease (Lin BioScience, San Diego). If approved by the FDA for Stargardt disease, the designation will qualify Lin BioScience for a priority review voucher, which is a program that is intended to encourage the development of therapies to prevent and treat rare pediatric diseases. LBS-008 is a first-in-class oral therapy that prevents the buildup of toxins in the eye that cause Stargardt disease and atrophic age-related macular degeneration, the company reported. LBS-008 received U.S. and European Union orphan drug designation in 2017 and 2018, respectively.

ASCRS task force to provide preliminary physician guidance regarding CyPass Micro-Stent ASCRS task force to provide preliminary physician guidance regarding CyPass Micro-Stent

The ASCRS has formed a task force to review data from the COMPASS-XT study and related research and to develop a preliminary physician guidance document associated with the Aug. 29 voluntary market withdrawal of the CyPass Micro-Stent (Alcon, Fort Worth, Texas). The task force is formed with ASCRS Clinical Committee leaders who specialize in glaucoma and cornea. They will perform an independent evaluation of the data, provide preliminary clinical recommendations regarding the monitoring of corneal health, and include suggestions to monitor patients with indwelling CyPass devices.

Submissions now open for the 2019 ASCRS/ASOA Annual Meeting

Submissions for the 2019 ASCRS/ASOA Annual Meeting are now open. Help shape the 2019 Annual Meeting program by submitting your instructional courses, papers, posters, films and photos. The deadline to submit courses, papers, posters, and films is Wednesday, October 17. The deadline for photo submissions is Friday, January 11, 2019. The 2019 ASCRS/ASOA Annual Meeting, being held May 3-7 in San Diego, is the largest U.S. meeting that offers integrated programming for anterior segment surgeons and practice management staff. Detailed information is now available on the Call for Submissions website. Please read the 2019 ASCRS/ASOA Annual Meeting Submission Guide before submitting your entry. All program faculty are required to register for the meeting. You can book your hotel for the meeting now, and registration will open Monday, October 15.


  • The global prevalence of presbyopia is significant, with a greater burden in rural areas in low-resource countries, according to a meta-analysis and systematic review performed by Timothy Fricke, MSc, and coresearchers. They focused on presbyopia prevalence and spectacle-correction coverage and modeled it to expand to country, region, and global estimates. They estimated that in 2015, there were 1.8 billion people around the world with presbyopia (prevalence, 25%), 826 million of whom had near vision impairment because of no vision correction or inadequate vision correction. The global unmet need for presbyopia correction in 2015 was estimated as 45%; those with presbyopia were more likely to have sufficient optical correction if they lived in an urban area of a more developed country that had a higher health expenditure and lower inequality. The research is published in Ophthalmology.
  • In a study that compared corneal astigmatism and shape between male and female eyes in relation to age, Ken Hayashi, MD, and fellow researchers found that against-the-rule (ATR) corneal astigmatism was greater and that ATR astigmatic change with age began earlier in male than female eyes. The study compared men and women in five age groups (40-49 years, 50-59 years, 60-69 years, 70-79 years, and 80 or older) who had videokeratographic evaluations using a Placido-Scheimpflug system. A total of 1,000 patients were included (100 eyes from males and 100 eyes from females in each of the age groups). The mean J0 of the total and anterior cornea were significantly smaller in the male than female eyes in all age groups. The mean J0 of the posterior cornea did not differ significantly except in the 50- to 59-year-old age group (P=.0105). The total and anterior corneal shape changed to ATR astigmatism with age in both sexes; this began at an earlier age in male eyes. Target astigmatism should be determined separately for men and women when performing astigmatism correction, the researchers concluded. The study appears in the Journal of Cataract & Refractive Surgery.
  • The injection of platelet-rich plasma (PRP) to treat severe dry eye was safe and effective at improving tear parameters and subjective parameters, reported Marcel Avila and coresearchers. Their prospective, interventional study included patients with severe dry eye who had been diagnosed with Sjögren's syndrome. The study divided the 30 patients into an intervention group (n=15) that received PRP injections on days 0, 30, 60, and 90 days as well as hyaluronic acid five times a day. There was also a comparison group (n=15) that received only hyaluronic acid five times a day. Primary outcome measures were changes in corneal staining, Schirmer test score, and tear breakup time (TBUT). The intervention group had improvements in all primary outcome measures compared with the control group, including a reduction in corneal staining (P<0.001), an increase in mean Schirmer value, and an increase in TBUT. There were also improvements in subjective Ocular Surface Disease Index values. The study is published in the British Journal of Ophthalmology.
  • There is a close relationship between ocular perfusion pressure and confirmed glaucoma in hypertensive patients, giving further evidence to the vascular mechanism in glaucoma pathogenesis, according to Erika Cantor and coresearchers. Their cross-sectional study evaluated the relationship among blood pressure, ocular perfusion pressure, and the occurrence of primary open angle glaucoma (POAG) among patients with systemic hypertension. Diagnosis of glaucoma was confirmed with visual field and optic nerve photos, and a multinomial logistic regression was used to assess the relationship among blood pressure, ocular perfusion pressure, and suspected or confirmed POAG. In the 1,272 individuals included in the study, 10.3% were diagnosed with suspected glaucoma and 5.1% with confirmed glaucoma. High diastolic blood pressure (>90 mm Hg) and low ocular perfusion pressure (<40 mm Hg) were associated with an increased risk for confirmed POAG. The type of antihypertensive treatment used by patients did not modify these relationships. The research appears in Clinical Ophthalmology.
Product news
  • The CAPSULaser, which creates a capsulotomy during cataract surgery in just over a second (Excel-Lens, Livermore, California), has received CE mark approval.
  • The OCT Angiography Module for Spectralis (Heidelberg Engineering, Heidelberg, Germany) received FDA clearance. It will be available for new and existing Spectralis upgradeable diagnostic imaging devices.
  • Katena Products (Denville, New Jersey) announced the launch of an upgraded website, katena.com, as an ecommerce and educational portal.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (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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