EW Weekly, March 13, 2020

STRIDE 3 trial results announced for EYSUVIS for dry eye
Topline results have been announced from STRIDE 3, a trial designed to evaluate KPI-121 0.25% (Kala Pharmaceuticals) for dry eye disease, according to a company news release. The company plans to commercialize under the name EYSUVIS (loteprednol etabonate ophthalmic suspension 0.25%). STRIDE 3 was a multicenter, randomized, double-masked, placebo-controlled, parallel-arm study that compared EYSUVIS to placebo, with patients in each group dosed four times a day for 2 weeks. There were 447 patients in the intent-to-treat population and 454 patients receiving vehicle. The trial showed a statistically significant improvement in ocular discomfort severity at day 15 in the overall intent-to-treat population (P=0.0002) and in the predicted subgroup of intent-to-treat discomfort at baseline (P=0.0007). There also was statistical significance for the key secondary endpoints of conjunctival hyperemia at day 15 in the intent-to-treat population and ocular discomfort severity at day 8 in the intent-to-treat population. There were no adverse events associated with KPI-121 0.25%. Company leaders will use the trial results for a Class 2 resubmission of the New Drug Application for EYSUVIS in the second quarter of this year.

Study in China finds conjunctival congestion in small percentage of COVID-19 patients
Conjunctival congestion was present in 0.8% of 1,099 patients with lab-confirmed COVID-19, according to a study recently published in the New England Journal of Medicine. Ophthalmologists may be among the first providers to see patients possibly infected with COVID-19, the American Academy of Ophthalmology reported. For this reason, when caring for patients potentially infected with COVID-19, ophthalmologists should protect their eyes, nose, and mouth. Slit lamp breath shields also can be helpful to protect staff and patients. On Wednesday, the World Health Organization declared COVID-19 a pandemic.

Hong Kong providers share infection control measures in ophthalmology during coronavirus outbreak
In an attempt to help ophthalmologists around the world better prepare for COVID-19, Tracy H.T. Lai and coresearchers published their experience with infection control measures in ophthalmology in Hong Kong. They had a three-level hierarchy of control measures, starting with administrative control. Patients received text messages to let them know where to call to reschedule an appointment or refill a prescription. A triage system was used to identify patients with fever, respiratory symptoms, acute conjunctivitis, or recent travel to outbreak areas. Those patients were advised to delay their appointments for at least 14 days. Micro-aerosol procedures such as non-contact tonometry and operations under general anesthesia were not performed, and elective procedures were stopped. All staff received training on infection control. To lower droplet transmission of the virus, staff installed protective shields on slit lamps and performed frequent equipment disinfection. They also were given eye protection. Staff were asked to measure their body temperatures before coming to work and to report symptoms of upper respiratory tract infection. Universal masking, hand hygiene, and the use of personal protective equipment were promoted. The report appears in Graefe’s Archive for Clinical and Experimental Ophthalmology.

Santen, TRACON stop development of DE-122 wet AMD
Santen Pharmaceuticals and TRACON Pharmaceuticals will stop the development of DE-122 to treat wet AMD after the review of top-line data from the Phase 2a AVANTE clinical study, a randomized controlled trial that assessed visual acuity after 6 monthly treatments with DE-122 and ranibizumab (Lucentis, Genentech) or with ranibizumab alone. DE-122 did not improve visual acuity when combined with Lucentis compared with the use of Lucentis alone, the companies reported.

Winning Pitch Challenge accepting submissions for symposium at ASCRS Annual Meeting

Do you have a winning idea that might transform ophthalmology? Industry partners and investors have committed $45,000 to winners, including $25,000 for first place.

The Winning Pitch Challenge provides the opportunity to compete for a chance to get the financial support and professional guidance needed to commercialize your innovative idea. Learn more, and submit your entry by March 18.

Research briefs
  • Cataract surgery increases melatonin secretion, and the use of clear IOLs versus yellow IOLs did not have differing results, reported T. Nishi and coresearchers. They focused on whether surgery would change melatonin secretion at 3 months postop in 169 adult patients. The parallel-group clinical trial randomized patients 1:1:1:1 to have cataract surgery using an artificial clear IOL or a yellow IOL. Group 1 had immediate surgery with a clear IOL, Group 2 had immediate surgery with a yellow IOL, Group 3 had delayed surgery with a clear IOL, and Group 4 had delayed surgery with a yellow IOL. Groups 1 and 2 were considered the intervention groups. Urinary melatonin excretion in the intervention group was measured at 3 months postop; in the control group, it was measured before delayed surgery. About 57% of the patients were men, and the mean age was 75.7 years. The mean urinary melatonin secretion was significantly higher in the control group (P=.007). When comparing Groups 1 and 3 (patients receiving clear IOLs), the concentration of urinary melatonin secretion was higher than the control group by creatine concentration. The difference between patients in Groups 2 and 4 (receiving the yellow IOL) was not significant. Melatonin secretion has been associated with depression, diabetes, cognitive impairment, and breast cancer, the researchers reported. The study is published in JAMA Ophthalmology.
  • Fluid reservoirs that are part of tabletop steam autoclaves can easily develop polymicrobial biofilms that can harbor microbial pathogens, according to an observational case-control study and review of the literature from Andrew Sorenson, MD, and coresearchers. These inert molecular byproducts can cause diffuse lamellar keratitis (DLK) and toxic anterior shock syndrome when introduced to the eye by surgical instruments. The 1,115 eyes in the study were reviewed after LASIK over a 5-year period. There had been multiple changes to the surgical and OR protocols prompted by a cluster of DLK cases, and the autoclave reservoir chamber wall was cultured for microbial contamination. Among 395 eyes that had LASIK from Sept. 2, 2010, to June 11, 2012, 37.2% developed DLK. However, systemic changes in surgical protocols were not effective at ending the DLK cases until the STATIM 2000 autoclave (SciCan) was replaced with a new STATIM autoclave and a reservoir sterilization and surveillance protocol were implemented. In the 30 months after that, the incidence of DLK lowered to 2.2%. The older autoclave reservoir chamber wall cultures grew Pseudomonas aeruginosa and the Burkholderia cepacia complex. Stringent reservoir cleaning and maintenance may remove the biofilms, the researchers concluded. The study is published in the Journal of Cataract & Refractive Surgery.

Product News
  • SYSTANE HYDRATION PF Lubricant Eye Drops (Alcon) is a new preservative-free option for those with dry eye who have sensitive eyes.
  • The second generation of the MicroPulse P3 Glaucoma Device (Iridex) was introduced. Newer features include a recessed fiber tip with an added fluid channel, a reduced footplate size for easier placement in eyes, and an elongated stem to improve visualization of the treatment area.

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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