EW Weekly, November 15, 2019

Phase 2 results announced from Nyxol eye drop study
Phase 2b results were announced from two trials with Nyxol Eye Drops (Ocuphire Pharma), according to a company press release. The MIRA-1 and ORION-1 studies showed that a once-a-day dosing provided visual acuity improvement and had a positive safety and tolerability profile. MIRA-1 was a multicenter, randomized, double-masked, placebo-controlled trial with 32 healthy subjects that focused on Nyxol’s ability to safely reduce pharmacologically-induced mydriasis. The primary endpoint of change from maximum pupil diameter at 2 hours post-treatment with one drop of 1% Nyxol compared to placebo was met. The ORION-1 multicenter, randomized, double-masked trial included 39 subjects with an elevated IOP of 22–30 mm Hg. The primary endpoint was the change from baseline in mean diurnal IOP. Although the change was not statistically significant, there was a trend toward greater IOP lowering in subjects with lower pressure at baseline who used Nyxol compared with placebo. Based on the results and other trials, Ocuphire leaders will prioritize the company’s clinical program to develop Nyxol for three indications: moderate-to-severe night vision disturbances, mydriasis reversal, and presbyopia. The company will begin two Phase 3 registration studies for night vision disturbances and mydriasis reversal and a Phase 2 study to study the use of Nyxol with a miotic agent for presbyopia treatment.

Biosimilars for AMD part of Biogen agreement
Biogen has entered into an agreement with Samsung Bioepsis to secure exclusive rights to commercialize two ophthalmology biosimilars—SB11, referencing Lucentis (ranibizumab, Genentech) and SB15, referencing Eylea (aflibercept, Regeneron Pharmaceuticals)—in major markets around the world, including the U.S., Canada, Europe, Japan, and Australia. Biosimilars have been shown to have similar efficacy and safety as the original improved biosimilar product, but they have a lower associated cost.

New moist heat therapy system
A new moist heat therapy system for the treatment of dry eye—eyecloud (Eye Eco)—launched this week as a direct-to-consumer product. According to the company, the system uses a warming technology, similar to that used for in-office dry eye treatments, to loosen oils in the meibomian glands during a 20-minute, at-home treatment session. Marc Schmitt, OD, said in a press release that his practice has used eyecloud for more than a year as an in-office treatment and has "been thrilled with the therapeutic relief it offers" patients.

Novaliq, Jiangsu Hengrui Medicine enter agreement for NOV03 and CyclASol in China
Novaliq and Jiangsu Hengrui Medicine have entered an exclusive license agreement to develop, manufacture, and commercialize NOV03 (perfluorohexyloctane) and CyclASol, both for dry eye disease, in the People's Republic of China, including China, Hong Kong, Macau, and Taiwan. Both drugs are in Phase 3 trials in the U.S.

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
  • The SToP method to calculate IOL power from measurements obtained with a Scheimpflug camera was one of the most accurate choices in a retrospective case series that focused on eyes with previous myopic excimer laser surgery, according to Giacomo Savini, MD, and coresearchers. Researchers studied corneal curvature measurements taken in eyes that had cataract surgery after myopic excimer laser surgery. Values taken from the two versions of the SToP calculator were used, based on the Holladay 1 and SRK/T formulas, respectively. They were compared with historical (Masket and Savini) and no-history methods (Barrett True-K, BESSt formula, equivalent K-readings, Triple-S, and Shammas). Among the 50 eyes of 50 patients analyzed, the SToP formula based on SRK/T had a lower median absolute error (0.31 D) and a higher percentage of eyes (62%) with a prediction error in refraction within ± 0.5 D. There also were excellent outcomes with the Masket, Savini, and Triple-S methods, as well as the BESSt formula. They had a median absolute error from 0.31–0.37 D and a higher percentage of eyes with a prediction error within ± 0.5 D (from 64–76%). The SToP formula based on Holladay 1 was slightly less accurate. The study appears in the Journal of Cataract & Refractive Surgery.
  • At 1 month after PRK, a marked decrease in the epithelial thickening pattern occurred, with gradual thickening at 3 and 6 months, reported Mohammad-Reza Sedaghat, MD, and coresearchers. This prospective study focused on longitudinal changes in epithelial thickness after myopic PRK among 52 eyes of 52 patients. Corneal epithelial thickness mapping by anterior segment OCT was performed, and epithelial thickness maps of 9 mm in diameter were divided into 25 sectors. PRK treatments were performed with the Technolas Teneo 317 model 2 excimer laser (Bausch & Lomb). There was a significant difference in thickness separately at various zones (P<.001) and a significant decrease in thickness at 1 month post-PRK in all zones. Epithelial thickening continued in all zones and reached the preop thickness in the midperipheral and peripheral zones at 6 months postop. Thickness in the central 5-mm zone was significantly thicker than before surgery. A significant correlation was seen between changes in spherical equivalent and epithelial thickness from before surgery to 6 months postop in the paracentral and peripheral zones. The research is published in the Journal of Refractive Surgery.
  • In an analysis of intraop and early postop adverse events among a large cohort of patients receiving LASIK or PRK over 2 years, Julie Schallhorn, MD, and coresearchers found that the procedures were safe with minimal adverse events. A total of 61,833 eyes had LASIK and 9,467 eyes had PRK. There were 850 adverse events for LASIK (incidence rate, 1.3%) and 227 for PRK (incidence rate, 2.3%). Among the LASIK patients, there were 287 serious adverse events (0.4%). In the PRK group, there were 65 serious adverse events (0.7%). Loss of two or more lines of corrected distance visual acuity occurred in 0.37% of all eyes when combining LASIK and PRK. The research is published in the American Journal of 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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