EW Weekly, May 1, 2020

ASCRS, AAO, OOSS release reopening checklist

ASCRS, the American Academy of Ophthalmology (AAO), and the Outpatient Ophthalmic Surgery Society (OOSS) issued guidance for the reopening of ophthalmic ASCs. The checklist, drafted by these organizations with contributions from the Ambulatory Surgery Center Association, details how to approach and manage several considerations for reopening surgical ophthalmic care in light of the COVID-19 pandemic. Find the full member alert and the checklist here.

Topline results: Dextenza for allergic conjunctivitis

Ocular Therapeutix announced topline results from its Phase 3 clinical trial evaluating Dextenza, an intracanalicular insert releasing dexamethasone, for ocular itching associated with allergic conjunctivitis. Dextenza is already FDA approved for ocular inflammation and pain following ophthalmic surgery. According to the company’s news release, the study’s primary endpoint was efficacy at day 8 after insertion. It was measured using the Ora Conjunctival Allergen Challenge Model with itching measured on a 5-point scale at 3 minutes, 5 minutes, and 7 minutes for 96 patients at six U.S. sites. Ocular itching was also evaluated at other time points. Patients with Dextenza had lower itching scores than control subjects except at one time point (day 7 at 3 minutes). There were no serious adverse events, no patients required rescue treatment, and no elevated IOP was observed.

Trial results for biocompatible MIGS implant

iStar Medical announced results from two clinical trials for its MINIject MIGS implant. According to the company, MINIject is a biocompatible implant that conforms to ocular anatomy. The implant is designed to enhance outflow from the anterior chamber to the supraciliary space. Outcomes from its 2-year STAR-I trial showed a mean, consistent reduction in IOP of about 40%; nearly half of patients were medication-free at the end of the trial with a mean medication reduction of 0.8. iStar Medical reported a minimal reduction in corneal endothelial cell density. Six-month results from the STAR-II EU trial also showed a 40% mean reduction of IOP, and 55% of patients were on no medications at this point.

Study: Very low-dose Avastin could effectively treat retinopathy of prematurity

According to a dose-finding study supported by the National Eye Institute (NEI), preterm infants at risk for blindness from retinopathy of prematurity (ROP) could be treated with a much lower dose of Avastin (bevacizumab, Genentech) than previously studied. A news release from NEI reported that 0.004 mg of the drug, which is approved for cancer therapy and used by ophthalmologists as an off-label intravitreal anti-VEGF injection, could be a lower effective dose to treat ROP. This is 0.6% of the dose used in a 2011 study that found Avastin had a benefit over conventional laser therapy in treating severe ROP, according to NEI. The children in this more recent study will be followed for long-term effects of each dose used in the study for evaluation of vision and organ development.

Topline data from pivotal study on novel glasses design for childhood myopia

SightGlass announced topline, 12-month data from its CYPRESS pivotal study of the company’s Vision DOT lenses for children with myopia. The ongoing study evaluated two test arms with glasses, which modulate peripheral contrast to reduce/slow myopia progression, against a control. The study involved 256 children (6–10 years old) at 14 sites in the U.S. and Canada who had myopia ranging from –0.75 D to –4.5 D. Interim 12-month data showed an up to 74% reduction in myopia progression in both test arms, with a change in cycloplegic spherical equivalent refraction from baseline. Both test arms also saw up to a 50% reduction in axial length progression. The company reported stable visual acuity and no serious adverse events.

Eyecelerator Live Stream series continues

Eyecelerator, the ASCRS and AAO partnership for innovation, continued its live stream sessions this week as part of the series “Ophthalmology 2.0: ReBooting the Ophthalmology Marketplace Post-COVID-19.” Wednesday’s live stream—ReInvent: Ophthalmology Recovery and Growth Through Digital Innovations—featured a keynote from Gregory Moore, MD, PhD, corporate vice president, Microsoft Health. Discussion was moderated by Ranya Habash, MD, and Gil Kliman, MD. Panel participants included Dr. Moore, Mark Blumenkranz, MD, CEO, Kedalion Therapeutics, and professor and chairman emeritus, Byers Eye Institute, Michael Boland, MD, PhD, director of information technology, Wilmer Eye Institute, Wende Hutton, general partner, Canaan Partners, Jane Rady, senior vice president corporate strategy and business development, Glaukos, Euan Thomson, PhD, head of Digital Business Unit, Zeiss, and Stephane Wolf, global head Digital Health Solutions, Ophthalmology, Novartis. More information on the Eyecelerator Live Stream series can be found here.

ASCRS: Virtual meeting and COVID-19: News You Can Use

The 2020 ASCRS Virtual Meeting is set for May 16–17, tailored to the new digital space with a variety of live and on-demand educational sessions. There will also be opportunities for interaction with industry through corporate-sponsored educational sessions and a full digital exhibit hall. For those already registered for the 2020 ASCRS Annual Meeting, registration will automatically be transferred to the 2020 ASCRS Virtual Meeting. Visit annualmeeting.ascrs.org for updates and information. ASCRS also continues its COVID-19: News You Can Use series, a repository of information including links, tips, and resources to help navigate the fluid COVID-19 landscape.

Research highlights
  • A new IOL power calculation method based on AI/machine learning was the most accurate in predicting IOL power when compared with other newer IOL power calculation formulas, according to a study published in the journal Eye. David Carmona Gonzalez, OD, and Carlos Palomino Bautista, MD, used various preop measurements, model and power of the implanted IOL, and subjective refraction at 3 months postop in 260 eyes of 260 patients to train different machine learning models. They wrote that “implanted lens characteristics and biometric data were used as input to predict IOL power and refractive outcomes.” The accuracy of the trained models was compared to Holladay 2, Haigis, Barrett Universal II, and Hill-RBF v2.0 in a dataset of 52 eyes. The researchers reported lower prediction error with the new method (called Karmona), followed by Haigis, Holladay 2, Barrett Universal II, and Hill-RBF v2.0. “Using the Karmona method, 90.38% and 100% of eyes were within ±0.50 and ±1.00 D respectively,” they wrote.
  • A survey of 100 cornea surgeons in the U.S. revealed various insights related to the learning curve associated with DMEK and factors that could be linked to graft failure within a surgeon’s first 10 cases using this technique. The paper detailing survey results by Ellen Koo, MD, and coauthors published in the journal Cornea revealed first that DMEK is the main keratoplasty procedure for 68% of respondents. Fifty-two percent had performed more than 20 DMEK cases at the time of the survey, and 51% felt comfortable with the procedure. Thirty-seven percent did experience a graft failure in their first 10 cases. The survey confirmed the importance of mentorship and guidance by a colleague experienced in DMEK to reduce primary graft failure during the learning curve.

Product news
  • Regener-Eyes announced closing of a Series A investment to launch its shelf-stable biologic for dry eye, Regener-Eyes LITE Ophthalmic Solution.
  • The FEMTO LDV 28 laser (Ziemer) received the CE mark for a new lenticule extraction application called CLEAR (Corneal Lenticule Extraction for Advanced Refraction).
  • E>Eye Laser (I-MED Pharma), already CE marked, received approval by Canada Health as a device to treat dry eye from MGD.

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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