Allogenic cell therapy receives FDA designations

Aurion Biotech announced that its AURN001, an allogenic cell therapy candidate for treatment of corneal edema secondary to corneal endothelial disease, received both a Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation from the FDA. These designations, according to the company, could expedite this drug’s development. The designations were granted based on unmet medical needs and clinical trials that have been conducted thus far.

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Robot delivers new treatment for wet AMD

According to a news article published by King’s College London, a custom-built robot delivering minimally invasive radiotherapy in a single treatment for wet AMD reduced the number of standard-of-care anti-VEGF injections these patients received. The article described the robotic treatment as “aiming three beams of highly focused radiation into the diseased eye” with better targeting than other methods. The report also noted that the robotic device “saves NHS £565 for each patient treated over the first two years.” The paper describing the stereotactic radiotherapy and the pivotal, randomized, double-masked, sham-controlled device trial is published in The Lancet.

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Health-related quality of life measure proposed for MIGS

The Glaucoma Outcomes Survey Collaborative Study Group sought to develop a standardized, patient-reported outcome measure to assess the impact of having glaucoma and its treatment options (including MIGS) on a patient’s health-related quality of life. An observational study was conducted before and after cataract surgery that was combined with a MIGS device procedure with patients taking an electronic survey on their outcomes. According to the paper published in the American Journal of Ophthalmology, 184 adults completed the Glaucoma Outcomes Survey (GOS) at baseline and 124 at 3 months; 106 patients completed the 1-month test-retest reliability survey. The GOS, according to the paper, includes 42 questions that assess functional limitations, vision-related symptoms, psycho-social issues, and satisfaction with MIGS. The survey was scored 0–100 with a higher score indicating worse health. According to the authors, this study provided initial support for the GOS. They advocated for further evaluation of the GOS in different patient subgroups and clinical settings.

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Company meets with FDA for pediatric myopia drug candidate

Vyluma announced that it had a Type A meeting with the FDA regarding the administration’s questions about its late-stage candidate for treatment of pediatric myopia, atropine sulfate ophthalmic solution, 0.01%. The company stated it will move forward with a submission to address the FDA’s questions in the third quarter. The company has conducted a multinational study that included 576 pediatric patients with myopia. According to the press release, the atropine sulfate ophthalmic solution was efficacious and was consistent with published literature.

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ASCRS news and events

• ASCRS Business of Refractive Cataract Surgery Summit: ASCRS is introducing a new course that will help practices gain the navigational tools needed to increase advanced-technology IOL adoption and lead patients on their refractive surgery journey. Learn more.
• ASCRS Live! The next stop for the ASCRS Live! dinner series, which is bringing education and networking events to several U.S. cities in 2024, is Washington, D.C., July 18. Register now.
• ASCRS Annual Meeting: The call for abstract submissions is now open for the 2025 ASCRS Annual Meeting in Los Angeles, California, April 25–28, 2025.
• 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.

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Research highlights

• In a retrospective chart review, a deep learning algorithm was developed to test and validate a cataract shadow projection theory that could allow for automatic, stable posterior polar cataract screening using fundus images. According to the study, published in the Journal of Cataract & Refractive Surgery, retrospective data (n=564) of ultra-wide field fundus images were used, and the authors tested “various model architectures and fields of view” for optimization. The final algorithm was 80% accurate and had 88.2% sensitivity and 93.4% specificity in screening for posterior polar cataracts on a clinical validation dataset. The authors noted that there was a significant relationship between posterior polar cataract and the projected shadow. They stated that this “may help surgeons to identify potential PPC risks preoperatively and reduce the incidence of posterior capsule rupture during cataract surgery.”
• A literature review published in the journal Cornea summarized different surgical approaches that combine PRK and corneal crosslinking along with their respective primary outcomes and associated adverse events. Thirty-seven papers were included that had PRK followed immediately by crosslinking. The authors wrote that the “latest research into simultaneous PRK and CXL has been shown to not only stabilize the cornea and prevent keratoconus progression but also improve the visual acuity of the patient.” In all protocols investigated, there were significant improvements in UDVA and spectacle-corrected distance visual acuity, as well as significant reductions in K1, K2, mean K, Kmax, sphere, cylinder, and spherical equivalent. The authors concluded that “combining the 2 procedures appears to be of net benefit, showing stabilization and improvement of ectatic disease, while also providing modest gains in visual acuity.”

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