EW Weekly, September 11, 2020

First patient enrolled in sustained-release intravitreal implant baseline treatment trial

Alimera Sciences announced the enrollment of the first patient in its NEW DAY trial, which will look at ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg as a baseline therapy for patients with diabetic macular edema. The study is multicenter, single-masked, randomized, and controlled trial designed to compare the sustained-release intravitreal implant to standard-of-care anti-VEGF (aflibercept) treatment. According to the company, the trial will enroll about 300 treatment-naïve (or almost naïve) patients with diabetic macular edema.

Enrollment complete for Phase 3 glaucoma trial of second-generation nitric oxide-donating bimatoprost analog

Nicox announced enrollment completion of its Phase 3 trial evaluating its second-generation nitric oxide-donating bimatoprost analog, NCX 470, compared to latanoprost ophthalmic solution, 0.005%, for patients with open angle glaucoma or ocular hypertension. The Mont Blanc trial is an adaptive design patient cohort to identify the optimal dose, the company stated, with NCX 470 0.065% and 0.1% being evaluated. The trial will span about 50 sites in the U.S. and a few in China.

Ocular Therapeutix addresses FDA warning letter for ReSure Sealant

Ocular Therapeutix announced in a press release that it has resolved the issue in a warning letter sent by the FDA in October 2018 for ReSure Sealant. According to the company, the letter was issued “based on the observed inability to conduct a study evaluating endophthalmitis rates following ReSure use in a post-approval Device Exposure Registry study required under 21 CFR 814.82(a)(2) as a condition within the premarket approval (PMA) application.” The company stated that it has since determined with the FDA that “the ability to enroll a study evaluating endophthalmitis rates was prohibitively challenging due to the size of the study that would have required tens of thousands of patients.” As such, Ocular Therapeutix will conduct a retrospective study using AAO IRIS Registry data to evaluate endophthalmitis rates at sites with access to ReSure compared to those without access.

20/Happy in 2020: ASCRS continues master class

This weekend ASCRS continues its “20/Happy in 2020: The ASCRS Master Class in Refractive Cataract Surgery,” which includes 18 AMA PRA Category 1 Credits TM as well as non-CME symposia that attendees can view live or watch later at their own pace. Every other week, live symposia will be aired on Saturdays, avoiding conflicts with clinic and OR time. At the conclusion of the multi-week master class, participants will receive a frameable certificate. A total of nine CME modules will cover topics including preoperative diagnostics, IOL calculations, IOL design, patient selection, education, and counseling, efficiency, and more, with discussion and expertise provided by a faculty of 80 surgeons from around the world. Sessions consist of lectures, audience Q&A, and live panel discussions. Attendees who don’t attend sessions live will have the opportunity to watch recorded versions. Saturday, September 12 features Module 3, a session on “Patient Evaluation and Selection—The Key to Refractive IOL Success.” Learn more and register at https://ascrs.org/20happy.

Research highlights
  • Endothelial cell density and morphology were compared in patients who had femtosecond LASIK vs. femtosecond SMILE. The prospective, cohort observational study published in the journal Clinical Ophthalmology included 80 eyes total, 40 that had LASIK and 40 that had SMILE. Myopia range overall was –0.75 D to –9 D, and age range was 19–37 years. According to the study, in the first month, there was a statistically significant decrease in endothelial cell density in both groups and a statistically significant increase in coefficient of variation. There was a significant decrease in hexagonality in both groups throughout the study period of 6 months. The researchers saw a greater effect on endothelial cell density with SMILE at 3 months and coefficient of variation with SMILE at 6 months. Investigators speculated this was due to deeper penetration of the laser in SMILE. No significant adverse effects on endothelial cell density or morphology were cited throughout the study period, according to the investigators, but they concluded that the effect of SMILE on corneal endothelial cells needs further investigation.
  • A prospective observational study reported the 5-year safety and efficacy outcomes of the first cultured human corneal endothelial cell injections for conditions of endothelial failure. According to the study published in Ophthalmology, 11 eyes of 11 patients who were pseudophakic with endothelial failure had injection of the cultured endothelial cells between December 2013 and December 2014. Several metrics were followed over the 5-year postop period with the primary outcome being central endothelial cell density and secondary outcomes being corneal thickness, BCVA, and IOP. At 5 years postop, normal corneal endothelial function was observed in 10 of the 11 eyes with a mean central corneal ECD of 1257±467 cells/mm2. According to the study, mean logMAR VA changed from 0.876 preop to 0.046 at year 5. There were also no major adverse events related to the injection therapy reported. With these findings, the study authors concluded that cultured human corneal endothelial cell injections are safe and effective out to 5 years postop.
  • A survey by the American Association of Pediatric Ophthalmology and Strabismus (AAPOS) of its members found that pediatric ophthalmology practices are “ominously strained, if not irreparably harmed” by the economic situation imposed by the COVID-19 pandemic. The survey published in the AAPOS journal noted that there are already less than 1,100 pediatric ophthalmologists in the U.S. Across all practice types surveyed in this group over a 5-day period in April, average revenue generation was 13% of usual, which the study authors stated is a “threat to the viability of practices across the United States.” The efficacy of economic aid for practice preservation has yet to be determined, the study authors continued. The survey also revealed that nearly 90% of pediatric ophthalmologists were furloughed or had their salary reduced. The authors noted that the survey doesn’t address mid- or long-term effects of the shutdown on pediatric ophthalmology practices, but they wrote that the “short-term effects of the pandemic suggest that practices will struggle to regain baseline levels of function,” and thus could decrease pediatric ophthalmologists’ service to patients.

Product news
  • Three CPT codes (0616T, 0617T, and 0618T) were issued for the Veo Ophthalmics CUSTOMFLEX ARTIFICIALIRIS for insertion of this device, which already has CMS pass-through payment status, a company press release announced.
  • BVI extended its range of Malosa single-use ophthalmic instruments to include instruments for corneal refractive surgery.
  • Ocular Therapeutix announced that another Medicare Administrative Contractor, National Government Services, which covers Medicare patients in 10 states, established a physician fee schedule for CPT code 0356T for drug-eluting intracanalicular inserts.
  • Nextech Systems announced a new glaucoma flowsheet for its ophthalmology-specific EHR, IntelleChartPRO.

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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