EyeWorld Weekly, February 25, 2022

EyeWorld Weekly, February 25, 2022

February 25, 2022 • Volume 28, Number 8

FDA accepts NDA for anesthesia, pain management drug

Harrow Health announced that the FDA accepted its NDA for AMP-100, an investigational drug for ocular surface anesthesia and intraoperative pain management during ocular surgery. The Prescription Drug User Fee Act target action date is October 16, 2022.

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Five-year results with intracanalicular microstent

A study published in the journal Ophthalmology described the 5-year, long-term results of the HORIZON trial, which compared cataract surgery alone to cataract surgery combined with the Hydrus Microstent (Ivantis/Alcon) in patients with primary open angle glaucoma. According to the study, patients with one or more glaucoma medications with a washed out diurnal IOP between 22–34 mm Hg and no prior incisional glaucoma surgery were included. A total of 369 eyes were randomized to receive the microstent in the study, and 187 received cataract surgery alone. Five-year follow-up was completed in 80% of eyes. At this point, the percentage of eyes that had an IOP of 18 mm Hg or less without medication was higher in the microstent group (49.5%) compared to the cataract surgery-alone group (34.8%). The group receiving the device was also more likely to have an IOP reduction of at least 20% without medications. The number of glaucoma medications was 0.5±0.9 in the Hydrus group compared to 0.9±0.9 in the cataract surgery-alone group at 5 years; 66% of eyes in the Hydrus group were medication-free compared to 46% of cataract surgery-alone eyes. The risk for incisional glaucoma surgery was lower in the group receiving Hydrus as well. There was no clinical or statistically significant difference in the rate of endothelial cell loss between 3 and 60 months among the two groups. Visual acuity was not different between the two groups.

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Request for information about ocular imaging

The National Eye Institute (NEI) is seeking information from the public on barriers to implementation of standards in ocular imaging. NEI is encouraging those in the ocular healthcare field, patients, those conducting vision research or in device manufacturing, and regulatory and policy makers to reply to the request for information by March 12.

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Post-hoc analysis of NMOSD treatment

Horizon Therapeutics announced post-hoc analysis of UPLIZNA (inebilizumab-cdon) treatment for neuromyelitis optica spectrum disorder (NMOSD). According to the company’s press release UPLIZNA is a B-cell depleting agent that is FDA approved for NMOSD treatment in adults who are anti-aquaporin-4 (AQP4) antibody positive. The post-hoc analysis was conducted to better understand the effect of the therapy on 11% of clinical trial participants who were not attack-free after treatment. The analysis found that of the 18 attacks that occurred in the UPLIZNA treatment group, 12 (67%) were minor and 6 (33%) were major (there were 10 [45%] and 12 [55%] major and minor attacks, respectively, in the placebo group). There were significantly higher levels of the serum glial fibrillary acidic protein (sGFAP) biomarker during major attacks vs. minor. The concentration of this biomarker was more significantly increased from baseline in the placebo group at the time of attacks but not in the UPLIZNA group. The level of serum neurofilament (SNFL) was higher in major vs. minor attacks, but it was not correlated with severity of optic neuritis attacks. The rates of this marker were also higher among those in the placebo group who had attacks vs. those in the UPLIZNA group. A researcher said in the press release that this analysis contributes to the understanding of how UPLIZNA impacts the severity of attacks that can continue to occur.

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Investigational visual prosthesis implanted in blind patient

Researchers led by the Pritzker Institute of Biomedical Science and Engineering at Illinois Institute of Technology implanted the first intracortical visual prosthesis to bypass the retina and optic nerve in patients blinded due to ocular disease or trauma. The research, according to a press release, is part of a Phase 1 feasibility study. The press release stated that the intracortical visual prosthesis is the first intracortical visual implant to use a group of fully implanted, miniature wireless simulators in an effort to provide artificial vision. The technology includes 25 simulators for a total of 400 electrodes. Research will evaluate whether participants who receive the implant experience improved ability to navigate and perform basic visual tasks.

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ASCRS news and events

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Research highlights

  • Teprotumumab, approved for thyroid eye disease, has been compared with placebo in randomized clinical trials for patients with thyroid eye disease, but a more recent study sought to perform an indirect comparison of the teprotumumab, placebo, and intravenous methylprednisolone (IVMP). IVMP, the authors wrote, is sometimes used for treatment of thyroid eye disease. Relevant randomized and observational studies were identified in PubMed and Embase with changes in proptosis and diplopia response from baseline to week 12 in patients receiving IVMP or placebo and to week 24 in those receiving teprotumumab. According to the paper, IVMP treatment resulted in a –0.16-mm proptosis difference from baseline to week 12 vs. placebo. The difference between IVMP and teprotumumab was –2.31 mm in favor of teprotumumab. The researchers reported that IVMP was not favored over placebo for diplopia response, but teprotumumab was favored over IVMP for this condition. “This meta-analysis suggests that use of IVMP is associated with a small, typically not clinically relevant, change from baseline in proptosis vs placebo, with modest changes in diplopia. While this nonrandomized comparison suggests that use of teprotumumab, compared with IVMP, is associated with greater improvements in proptosis and may be twice as likely to have a 1 grade or higher reduction in diplopia, randomized trials comparing these 2 treatments would be warranted to determine if 1 treatment is superior to the other to a clinically relevant degree,” the authors wrote. This study is published in JAMA Ophthalmology. 
  • The first known use of telementoring in corneal surgery was described in a paper published in the journal Cornea. The case involved the NGENUITY 3D microscope (Alcon), 5G live-streaming technology, group chat, and virtual reality headsets used by the surgeons. According to the paper, three surgeons in Toronto were proctored by a surgeon in Israel on the implantation of the novel CorNeat KPro. The primary outcome was successful completion of the procedure into cadaver eyes. The surgeons were interviewed afterward and reported significant satisfaction with the telementoring situation. According to the paper, a cumulative score from the postop questionnaire was 149 out of 150 from the operating surgeons and 135 out of 150 from the proctor. They reported no lag time and recommended the technology. The authors concluded that such “telementoring is a promising tool that can traverse large distances for ophthalmic education.”

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Product news

  • TYRVAYA Nasal Spray (varenicline solution, Oyster Point Pharma) is now covered by Express Scripts.
  • VYZULTA (latanoprostene bunod ophthalmic solution, Bausch + Lomb) has been commercialized in seven territories and nine additional countries.

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This issue of EyeWorld Weekly was edited by Stacy Jablonski and Liz Hillman.

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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