EW Weekly, August 31, 2019

FDA approves AcrySof IQ PanOptix Trifocal IOL
The FDA has approved the AcrySof IQ PanOptix Trifocal IOL, according to a press release from Alcon. It is the first and only trifocal lens available in the U.S. PanOptix is already available in more than 70 countries. Approval was based on a pivotal study at 12 investigational sites in the U.S.

FDA: Sufficient data for human study of EVO/EVO+ Visian lens
The U.S. FDA has stated that it has enough data from STAAR Surgical Company to support a human clinical trial in the U.S. of the EVO/EVO+ Visian Implantable Collamer Lens for myopia and the EVO/EVO+ Visian Toric Implantable Collamer Lens for myopia with astigmatism, according to a STAAR press release. The FDA also recommended study design modifications that STAAR plans to incorporate into its investigational plan that will be part of a revised submission. The current plan for the study reflects the FDA’s recommendations from ongoing interactive dialogue regarding the investigational protocol, including 300 subjects. The actions are part of the product’s Investigational Device Exemption with the FDA.

Combination of THR-317 and ranibizumab for DME safe, well-tolerated
Topline month 3 results from a Phase 2a study evaluating THR-317 in combination with ranibizumab for diabetic macular edema (DME) were reported by Oxurion. The randomized, single-masked, active-controlled, multicenter study assessed the safety and efficacy of three monthly intravitreal injections of THR-317 and ranibizumab in subjects with center-involved DME versus ranibizumab and sham, for a total of 70 patients. Best corrected visual acuity (BCVA) was the study’s primary endpoint. No improvement was observed in mean BCVA at month 3 when combination therapy was compared to ranibizumab monotherapy. Using the Early Treatment Diabetic Retinopathy Study eye chart, the combination therapy achieved an 8.71-letter increase versus 8.18 letters in the monotherapy arm. Combination therapy did show improvements at month 3 in patients with poor or no response to anti-vascular endothelial growth factor (VEGF) and in patients with a baseline BCVA of 65 or fewer letters. There were no drug-related ocular serious adverse events.

Iconic Therapeutics signs option agreement with Novartis
Iconic Therapeutics has signed an agreement with Novartis that provides Novartis with an option on Iconic's ophthalmology program, which is now in Investigational New Drug-enabling studies. Iconic is currently assessing its anti-tissue factor monoclonal antibody ICON-4 to potentially treat age-related macular degeneration (AMD). Trials are slated to begin next year.

Study: Cataract surgery safe, effective over time
A prospective, population-based cohort 20-year follow-up study found that cataract surgery provides excellent long-term visual rehabilitation for the majority of patients, including younger patients, reported Eva Monestam, MD, and coresearchers. Their study evaluated 114 patients who had cataract surgery 20 years previously and who answered the VF-14 questionnaire before surgery and at 2 to 4 months and 5, 10, 15, and 20 years postop. Eighty-eight percent of patients also had a routine ocular examination that included BCVA. After 20 years, the median BCVA of the operated eye changed from a Snellen visual acuity of 20/20 to 20/23. The largest loss of BCVA took place in patients aged 70 or older. Fifty-five percent of patients had no deterioration of subjective visual function; 72% of patients had declines of 10 points or less. There was a greater decline in the VF-14 total score over 20 years in older patients. Sixty-one percent of patients had not been treated for posterior capsular opacification. The study results could be of value when counseling younger patients who are considering clear lens surgery, the authors concluded. The study appears in the Journal of Cataract & Refractive Surgery.

One month left to nominate a candidate for the ASCRS Ophthalmology Hall of Fame
Be sure to submit your nomination for the 2020 ASCRS Ophthalmology Hall of Fame before the September 24 deadline. Eligible candidates are those with 25 or more years of scholarly achievement and at least one solid, defining contribution to ophthalmology in clinical practice, research, education, invention, or humanitarian work. Chosen inductees will be recognized at the 2020 ASCRS Annual Meeting, being held May 15–19, in Boston. An induction ceremony will be held during the ASCRS Opening General Session on May 16.

Research briefs
  • In patients with allergic conjunctivitis, there was no significant difference between sublingual allergen immunotherapy (SLIT) versus subcutaneous allergen immunotherapy, according to Khulood Sayed and coauthors. Their prospective comparative case series study was done on 100 patients with a positive skin prick test and high-serum immunoglobulin E levels. Two groups were formed (50 patients each) to offer SLIT or subcutaneous immunotherapy and were followed for a year. Pre- and post-treatment symptoms were compared to assess efficacy. Aeroallergens—particularly, pollens and house dust—were significantly more common than food allergens. Both SLIT and subcutaneous therapy led to a clinical and immunological improvement at 12 months and was evident in all follow-up parameters. Patients tolerated the allergen therapies without any serious adverse events. The study is published in Graefe's Archive for Clinical and Experimental Ophthalmology.
  • Chronic exposure to the high levels of air pollution via ambient nitrogen dioxide or carbon monoxide significantly increased the risk of AMD in a population-based study using data from the Taiwan National Health Insurance Program between 2000 and 2010, reported Huang-Hsi Chang and coresearchers. Subjects included were age 50 or older, and the annual total nitrogen dioxide and carbon monoxide exposure was calculated from 1998 to 2010 for each subject. A total of 39,819 people were enrolled, 1,442 of whom developed AMD during the study's 11-year follow-up period. The highest quartile of each air pollutant was associated with an increased risk for AMD. The study is published in the Journal of Investigative Medicine.
  • Eyes that had previous incisional glaucoma surgery and went on to have intravitreal anti-VEGF injections had a significantly lower post-injection IOP elevation as well as a faster recovery to within 10 mm Hg of their pre-injection IOP, according to Jocelyn Lam and coresearchers. In their experimental study, pre- and post-injection IOP measurements were compared along with time to recovery to within 5 and 10 mm Hg of baseline IOP. Ten eyes with a history of glaucoma surgery and 29 control eyes receiving anti-VEGF injections were part of the study. Proliferative diabetic retinopathy was the most common indication for injections. The mean change in IOP after intravitreal injections was lower in surgical eyes (10.7 mm Hg versus 28.6 mm Hg). Mean time for IOP to return to within 10 mm Hg of pre-injection IOP was less in surgical eyes (5.2 versus 13.3 minutes). Incisional glaucoma surgery may be an option in patients where attenuation of post-injection IOP elevation is needed and other less invasive measures have failed, the researchers concluded. The study appears in Graefe's Archive for Clinical and Experimental Ophthalmology.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), 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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