FDA grants 510(k) indication expansion for MIGS tool

New World Medical was granted 510(k) clearance for an expanded indication for its KDB (Kahook Dual Blade) Glide. The expanded indication allows KDB Glide to be used to perform goniotomy for primary open angle glaucoma during cataract surgery or as a standalone procedure.

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FDA approves biosimilar for aflibercept

Biocon Biologics announced FDA approval of its Yesafili (aflibercept-jbvf) as an “interchangeable biosimilar aflibercept.” According to the company, Yesafili is intended to treat wet AMD, visual impairment due to macular edema secondary to RVO, diabetic macular edema, and myopic choroidal neovascularization. The company’s press release noted its similarities in quality, safety, and efficacy to Eylea (Regeneron).

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De Novo Marketing Authorization granted for home OCT device

Notal Vision announced that the FDA has granted De Novo Marketing Authorization for its SCANLY Home OCT device, intended for patients with wet AMD. According to the company’s press release, the device captures spectral-domain OCT images in a 10 x 10-degree area centered on the point of fixation and uses the AI-based Notal OCT Analyzer to segment and estimate the volume of hypo-reflective spaces, which are biomarkers for managing the disease.

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Consensus guidelines for suprachoroidal drug delivery

A group of retina specialists have published guidelines for best practices for injections into the suprachoroidal space, basing their recommendations on published evidence and clinical experience. “Suprachoroidal space injection technique: expert panel guidance” was published in the journal Retina.

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ASCRS news and events

• ASCRS Live!: This dinner series, making its way to nine cities, is continuing to bring ASCRS education around the U.S. Next up: Houston, Texas. Register now.
• ASCRS 50th Anniversary: ASCRS members from the 50 states are sending in their perspectives on the Society, its impact on their career, and its influence on the specialty as a whole. Stay tuned each week through April 2025 for a new video.
• ASCRS Annual Meeting: Hotel blocks are open for the 2025 ASCRS Annual Meeting in Los Angeles, California, April 25–28, 2025.

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Research highlights

• A retrospective study of 1,703 eyes from the same number of consecutive patients sought to compare the CDVA outcomes of hyperopic LASIK with postop corneal steepness above and below 49 D. Patients had surgery between 2013 and 2019 and were divided into two groups: those with postop corneal steepness more than 49 D and those with 49 D or less (control). The authors found that preoperatively, the steep group had a steeper mean and steep keratometry, worse logMAR CDVA, and higher sphere. Intraoperatively, the authors reported, this group had a higher spherical treatment. Postop, the steep group had worse logMAR CDVA, but after adjustments in baseline differences and spherical treatment, there were no differences identified in postop logMAR CDVA. The authors stated that factors that were still associated with worse postop CDVA were higher spherical treatment and preop CDVA. The authors concluded that the “49 D cutoff should be revisited,” because it was not associated with worse visual outcomes after hyperopic LASIK. This study was published in the Journal of Cataract & Refractive Surgery.
• A randomized clinical trial investigated the effect of re-esterified ω-3 triglyceride fatty acid supplementation on dry eye disease associated with MGD. Patients with dry eye associated with MGD were assigned to receive 1,680 mg of eicosatetraenoic acid and 560 mg of docosahexaenoic acid daily (ω-3 group) or 3,000 mg of grape seed oil daily (control). The study included 132 patients whose mean OSDI scores were 43.5 in the ω-3 group and 44.1 in the control group. After 12 weeks of follow-up with no differences in compliance with the supplements, the OSDI change from baseline to 6 and 12 weeks was –20.5 and –22.7 in the ω-3 group, respectively, and –15.1 and –18.8 in the control group, respectively. The authors found no benefit to re-esterified ω-3 triglyceride fatty acid supplementation on symptoms of dry eye associated with MGD. The research is published in the journal JAMA Ophthalmology.

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Product news

• DryEye Rescue has become the sole distributor of InflammaDry, a diagnostic tool for dry eye disease, in the U.S.
• Reichert Technologies launched the Tono-Vera Tonometer with ActiView Positioning System in the U.S.
• Haag-Streit launched Imaging Module 910 3D for documentation of slit lamp images with the addition of a second 4K camera. This, according to the company, enhances visualization.

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