EW Weekly, July 26, 2019

OMIDRIA receives J-Code from CMS
The Centers for Medicare and Medicaid Services has assigned a permanent product-specific J-code for OMIDRIA (phenylephrine and ketorolac intraocular solution, Omeros). OMIDRIA is used during cataract surgery to prevent miosis and decrease postop pain. The new code, J1097, will be effective on October 1.

Patient enrollment complete in Phase 1 trial for glaucoma implant
Patient enrollment is complete in a Phase 1 clinical trial from PolyActiva to evaluate the safety and tolerability of its biodegradable, slow-release ocular implant to treat glaucoma, according to a company press release. The company's implant, Latanoprost FA SR Ocular Implant, provides a constant daily therapeutic dose of latanoprost free acid for at least 30 weeks. To date, the implant is safe and well tolerated, the company reported. Topline safety and initial efficacy data are expected to be released by the end of this year. PolyActiva also announced funding for its next clinical studies, one of which will identify the efficacious dose for the glaucoma implant, and a study with the company’s ocular implant to prevent endophthalmitis after cataract surgery. Both of those studies are slated to begin in October.

Global licensing agreement commenced with Glaukos, Intratus
Glaukos and Intratus have entered into a licensing agreement that grants Glaukos a global exclusive license to research, develop, manufacture, and commercialize Intratus' patented, noninvasive drug delivery platform to treat dry eye disease, glaucoma, and other corneal disorders, according to a press release from the two companies. The patented cream-based drug formulations from Intratus are applied to the outer surface of the eyelid for transdermal delivery of pharmaceutically active compounds to treat eye disorders.

Enrollment complete in Phase 2 study of NCX 470
Enrollment has been completed in a Phase 2 clinical study for NCX 470 (Nicox), a second-generation nitric oxide-donating bimatoprost analog tested in patients with open angle glaucoma or ocular hypertension to lower IOP, according to a company press release. The multicenter, double-masked, 28-day, parallel group, dose-response study evaluates the efficacy and safety of NCX 470 compared to latanoprost ophthalmic solution 0.005% in patients with elevated IOP. The study is a head-to-head comparison of once-daily use of three different doses of NCX 470 versus latanoprost. The study's primary endpoint is the mean reduction in diurnal IOP after 28 days of treatment. The last patient is expected to exit the study by the end of August; topline efficacy results are expected by the fourth quarter of this year.

Ocuphire Pharma raises more than $5 million to complete clinical trials
Ocuphire Pharma has closed on more than $5 million of financing that will be used to fund multiple clinical trials of its lead drug candidate, Nyxol, according to a company press release. Nyxol, a once-daily proprietary ophthalmic formulation of phentolamine mesylate, is an eye drop treatment for night vision disturbances, glaucoma, and reversal of mydriasis. Safety and efficacy data from Phase 1 and Phase 2 trials have shown that the formulation moderately reduces pupil size and significantly lowers IOP. The company is currently enrolling patients for its double-masked, placebo-controlled trials in glaucoma (ORION-1) and reversal of mydriasis (MIRA-1) at sites across the U.S.; clinical results are expected to be announced later this year. A Phase 3 study of Nyxol for night vision disturbances is expected soon, the company reported.

2019 ASCRS and ASOA Combined Ophthalmic Symposium hotel deadline next week
Next week, Wednesday, July 31, is the last day to reserve your hotel at a reduced rate through the official ASCRS and ASOA Combined Ophthalmic Symposium hotel block at the JW Marriott Austin. The ASCRS and ASOA Combined Ophthalmic Symposium is being held August 23–25 in Austin, Texas. Register and secure your room today.

Research briefs
  • Resident-performed cataract surgery on monocular patients was acceptable in a retrospective case series, but the majority of residency programs in the study did not have specific guidelines for residents performing surgery in this patient group, reported Iinyi Chen, BS, and coresearchers. The researchers surveyed cataract surgery educators across the U.S. on their policies regarding residents performing cataract surgery on monocular patients and used a second survey to assess resident opinions on performing surgery in such patients. A retrospective chart review was completed of all monocular patients who had resident- and attending-performed cataract surgery at the same academic institutions. A total of 47 residency programs responded to the survey. Only 18 of the programs had specific policies related to residents performing cataract surgery in monocular patients. Residents (response rate=39.1%) were more anxious and did more preparation for monocular cases than routine cataract cases. Intraop complications (9.7% versus 5.6%) and postop visual outcomes were comparable between resident and attending surgeon monocular cases. The study is published in the Journal of Cataract & Refractive Surgery.
  • Higher serum cholesterol in adults age 40 or older was associated with a higher risk of primary open angle glaucoma (POAG), reported Jae Kang, ScD, and coresearchers. The population-based cohort study reviewed data collected from participants free of glaucoma in the Nurses’ Health Study (n=50,710; followed from 2000 to 2014), the Nurses & Health Study 2 (n=62,992; followed from 1999 to 2015), and the Health Professionals Follow-up Study (n=23,080, followed from 2000 to 2014). Among the 166,782 participants in the three cohorts, 886 incident cases of POAG were found. For every 20-mg/dL increase in total serum cholesterol, there was a 7% increase in risk of POAG (P=.004). A self-reported history of elevated cholesterol was also associated with a higher risk of POAG. Any statin use history was associated with a 15% decreased risk for POAG, while the use of statins for 5 or more years versus never was associated with a 21% lowered risk. The study is published in JAMA Ophthalmology.
  • Preop endothelial cell density (ECD) was unrelated to late endothelial graft failure in eyes having Descemet's stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study, reported Sanjay Patel, MD, and coresearchers. However, a lower ECD at 6 months was associated with late endothelial graft failure. Their cohort study within the multicenter, randomized clinical trial included 1,007 patients (1,223 study eyes) with a mean age of 70 years who were having DSAEK for Fuchs&rsquo; dystrophy or aphakic corneal edema and followed for up to 5 years. The cumulative probability of late endothelial graft failure was 1.3%. The median preop ECDs were similar for eyes with late endothelial graft failure and eyes without failure. The ECD at 6 months was associated with late endothelial graft failure (P<0.001) in time-to-event analyses, but preop ECD was not (P=0.55). Cumulative incidence of late endothelial graft failure was 6.5% for 97 grafts with a 6-month ECD less than 1,200 cells/mm2, 0.3% for 310 grafts with a 6-month ECD between 1,200 and 2,000 cells/mm2, and 0.6% for 589 grafts with a 6-month ECD greater than 2,000 cells/mm2. Early endothelial cell loss after DSAEK and intraop complications should be reduced to improve graft survival, the researchers concluded. The study appears in 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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