EW Weekly, November 8, 2019

Expanded trial results from Aldeyra's allergen chamber trial for reproxalap released
Expanded results released from an allergen chamber trial for reproxalap (Aldeyra Therapeutics) found statistically significant activity relative to control, according to a company press release. The double-masked, randomized, vehicle-controlled, crossover chamber trial compared the efficacy and safety of 0.25% and 0.5% concentrations of reproxalap with vehicle in 70 patients who were allergic to ragweed. The test article was administered before allergen chamber entry and at 90 minutes post-entry. Ocular itching and tearing as reported by patients and investigator-assessed ocular redness were recorded at various intervals. The total ocular symptom score was significantly lower in reproxalap-treated subjects than vehicle-treated subjects. There was no statistical difference between the activity of 0.25% and 0.5% reproxalap. The Phase 3 INVIGORATE trial with reproxalap is slated to begin in the first half of 2020 and will compare 0.25% reproxalap versus vehicle in an allergen chamber.

Phase 2 study topline results announced for netarsudil in Japan
Aerie Pharmaceuticals announced topline results from its Phase 2 trial evaluating netarsudil ophthalmic solution in Japan. The agent is known in the U.S. as Rhopressa and is approved for elevated IOP in patients with open-angle glaucoma (OAG) or ocular hypertension. The agent is under regulatory review in the European Union, where it is called Rhokiinsa. The 28-day study evaluated the IOP-reducing effect and safety of three concentrations of netarsudil (0.01%, 0.02%, and 0.04%) compared with placebo in subjects with OAG or ocular hypertension. Among the 207 randomized subjects who completed the study, the average baseline IOPs ranged from 20.3 mm Hg to 21.1 mm Hg across the study's four arms. At day 29, the mean diurnal IOP was statistically significantly lower in subjects treated with each of the netarsudil combinations compared with placebo. Netarsudil reduced mean diurnal IOP by 4.1 to 4.6 mm Hg for the 0.01% concentration, 4.4 to 4.8 mm Hg for the 0.02% concentration, and 4.8 to 5.1 mm Hg for the 0.04% concentration. These all compared to the placebo arm, which reduced the mean diurnal IOP by a range of 1.4 to 1.7 mm Hg. Conjunctival hyperemia was the most common adverse event in both the netarsudil arms and the placebo arm.

Study: Better opioid control possible after corneal surgery
Patients used fewer opioid tablets after corneal surgery when patients were prescribed fewer tablets, reported Maria A. Woodward, MD, and coresearchers in JAMA Ophthalmology. Their prospective cohort study focused on opioid use after corneal surgery using direct interviews of two adult patient cohorts separated by an updated opioid prescribing guideline. The first survey evaluated the quantity of opioid tablets used postoperatively. Additionally, the cornea division of a tertiary care academic medical center reviewed the use needs and lowered the number of tablets prescribed after routine cases. A second cohort received a more detailed survey that focused on use, opioid disposal, and pain control. A total of 38 participants were part of the first cohort and 44 were in the second cohort. Among those receiving opioid prescriptions, the first cohort was prescribed significantly more tablets than the second cohort (mean, 18.8 versus 6.6). The first cohort also used significantly more tablets than the second cohort (mean, 8.3 versus 4.0). Among the second cohort, 70% reported pain control as adequate, and 22% said it was more than needed. Most participants had leftover tablets. The majority did not dispose of the leftovers; 15% threw away the leftover opioids or flushed them.

DEXYCU and YUTIQ added to Veterans Affairs federal supply schedule
DEXYCU and YUTIQ (both from EyePoint Pharmaceuticals) will be added to the Federal Supply Schedule, per an interim agreement with the U.S. Department of Veterans Affairs, according to an EyePoint press release. The final contract is slated to be executed in the next few months and will have a 5-year term, according to the news release.

FDA accepts BLA for satralizumab for neuromyelitis optica spectrum disorder
The FDA has accepted the Biological License Application for satralizumab, designed to treat adults and teenagers with neuromyelitis optica spectrum disorder. Additionally, the European Medicines Agency has validated the company's Marketing Authorization Application and has granted the agent Accelerated Assessment.

Submit your nomination for the inaugural ASCRS Educator Award
The new ASCRS Educator Award recognizes an ASCRS member who has made education an enduring career priority. Nominees must: have demonstrated passion and commitment to education, leadership, and selflessness in the pursuit of expanding knowledge in the interest of improving patient outcomes; be an ophthalmologist focused on anterior segment surgery; have at least 5 years in practice; and be a current ASCRS member. Nominations are due by November 29. Find more information at ascrs.org/educatoraward.

Research briefs
  • A 10-year study found that age-related cataract was a predictor for poorer survival compared to those without cataract and may imply that cataract is a biomarker for aging and frailty, reported Zhuoting Zhu and coresearchers. Their research focused on a total of 1,405 participants age 50 or older in China who were examined at baseline in the Guangzhou Liwan Eye Study and then invited to attend a 10-year follow-up visit. Cataract cases were defined as having visible lens opacity confirmed with direct ophthalmoscope under pupil dilation or a previous history of cataract surgery. Researchers also tracked visual impairment, body mass index, and various demographics via a brief questionnaire. Among the participants examined at baseline, 68.1% had visible lens opacity or a history of cataract surgery. Over the subsequent 10 years, 22.8% died. The 10-year mortality rate was significantly higher in those who had cataract compared with those who did not (30.1% versus 7.14%). After adjustments, the presence of cataract predicted a nearly three-fold increase in mortality risk. The study is published in Acta Ophthalmologica.
  • A systematic review and meta-analysis of extended depth-of-focus IOLs found that this type of IOL provided better intermediate and near visual acuity than monofocal IOLs but also increased the risk of contrast reduction and more frequent haloes, reported Jing Liu and coresearchers. They assessed nine studies with a total of 1,336 eyes. A subgroup analysis was done according to the IOL type used in the control group. Extended depth-of-focus IOLs produced better uncorrected intermediate visual acuity and uncorrected near visual acuity. There also was increased spectacle independence, lowered contrast sensitivity, and more frequent haloes. Extended depth-of-focus IOLs performed better than trifocal IOLs in contrast sensitivity. There were no adverse events reported in the studies. The review article is published in BMC Ophthalmology.
  • When comparing the precision of bag-in-the-lens IOL power calculations among pediatric cataract patients of different ages, Lyubomyr M. Lytvynchuk, MD, PhD, and coresearchers found a larger prediction error in the youngest study group, which gradually became smaller with age and in eyes with axial lengths shorter than 20 mm. Their retrospective nonrandomized consecutive case series included 87 eyes of 56 pediatric patients. Patient age groups were 0 to 3 months (Group 1), 3 months to fewer than 12 months (Group 2), 12 months to 36 months (Group 3), and greater than 36 months to 17 years (Group 4). The bag-in-the-lens power was calculated with the SRK/T formula, and the prediction error was defined as the absolute difference between preop selected target and postop achieved refraction. The mean and median prediction errors overall were 1.79 D and 1.23 D, respectively. The mean prediction error in Group 1 was 3.43 D, 2.14 D in Group 2, 1.60 D in Group 3, and 1.33 D in Group 4. For eyes with axial lengths shorter than 20 mm, the mean prediction error was 2.67 D, compared with 1.44 D in eyes with an axial length of 20 mm or longer. Prediction error should be considered during bag-in-the-lens IOL power calculation in children, the researchers concluded. The study appears in the Journal of Cataract & Refractive Surgery.

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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