EW Weekly, February 26, 2021

PMA submitted to FDA for small-aperture IOL
AcuFocus submitted its Premarket Approval (PMA) application to the FDA for the IC-8 small aperture IOL. This aspheric monofocal IOL has an embedded filter with a small central aperture, the company’s press release said, which allows the lens to “mitigate harmful visual effects of unfocused peripheral light.” This design also achieves continuous extended depth of focus, according to the press release. IC-8 already has the CE mark and is available in some European and Asian markets.

Preclinical results for new class of non-prostaglandin analogs for IOP lowering
Nicox announced the publication of pre-clinical results for its nitric oxide (NO)-donating compound NCX 1741, a new class of non-prostaglandin analog IOP-lowering agent. The results published in the Journal of Ocular Pharmacology and Therapeutics showed NCX 1741 had similar IOP-lowering effects to travoprost in a non-human primate model for ocular hypertension. According to a press release about the research, the onset of action of NCX 1741 was faster than that of travoprost. NCX 1741 is an analog of Nicox’s development candidate NCX 1728, the company noted.

A Phase 2 clinical trial begins enrollment for topical presbyopia-correcting drop
Ocuphire Pharma has begun enrolling its first patients for a Phase 2, proof-of-concept trial that will evaluate Nyxol (phentolamine)—already shown in other Phase 2 trials to reduce pupil diameter with improved in near visual acuity—and low-dose pilocarpine to reduce symptoms of presbyopia. The company’s press release about the research stated that 12 sites will be involved in the trial that will have patients administer one drop of Nyxol in the evening and pilocarpine during the day. The randomized, double-masked, placebo-controlled trial will enroll about 150 patients with near visual acuity of 20/50 or worse with a primary endpoint being the percentage of patients with at least three lines of improvement in binocular distance-corrected near visual acuity in daylight conditions.

Home OCT technology used in clinical trial to reduce participant visits to offices
Notal Vision partnered with AsclepiX Therapeutics for its Phase 1 clinical trials of AXT107 for DME and wet AMD. According to Notal Vision’s press release, the company will provide Notal Home OCT devices for study participants who will self-image their eyes. Imaging and data analysis from this monitoring will be used to identify intra- and subretinal fluid, with OCT images and temporal fluid volume trajectories being shared with AsclepiX. The Notal Vision technology, according to the company’s press release, will allow researchers to obtain data points while reducing the burden of frequent office visits for study participants.

ASCRS Journal Club on March 11
Plan to join ASCRS’ interactive Journal Club on Thursday, March 11, from 9:00–10:00 p.m. ET for another session of this monthly series in which a panel of experts discuss two pre-selected manuscripts from the Journal of Cataract & Refractive Surgery. Nick Mamalis, MD, and Leela Raju, MD, co-moderate these free CME sessions, open to all ASCRS members. The March session will feature Divya Srikumaran, MD, and Matthew Santos, MD, as discussants, and David Chang, MD, Eric Donnenfeld, MD, and Alice Epitropoulos, MD, as panelists.

Research highlights
  • Research looked at the surgical outcomes of ophthalmologists who have an exclusive surgical focus vs. those who are more diversified in the surgeries they perform. The population-based cohort study involved all patients 66 years and older who had cataract surgery between January 2002 and December 2013 in Ontario, Canada, totaling more than 1 million cataract surgeries. Surgeons who performed these procedures were classified as exclusively cataract surgeons, moderately diversified cataract surgeons who performed 1–50% non-cataract procedures, and highly diversified surgeons who performed more than 50% non-cataract procedures. The main outcome was a composite of four adverse events (posterior capsule rupture, dropped lens fragments, retinal detachment, and suspected endophthalmitis). According to the research, adverse events occurred in 0.73% of cases performed by exclusive cataract surgeons, 0.78% of cases performed by moderately diversified surgeons, and 2.31% of cases performed by highly diversified surgeons. The authors concluded that an exclusive surgical focus on cataract surgery did not affect safety of the procedure when compared to surgeons who were moderately diversified, but there was a high risk of adverse events in surgeries performed by ophthalmologists where the majority of their practice was not cataract surgery. The research is published in the journal Ophthalmology.
  • A study that looked at electronic records of patients 21 years old and younger who were referred to an early keratoconus clinic sought to determine the clinical implications, financial cost, and service capacity of waiting for those in this group to show “documented progression” prior to receiving crosslinking. The authors noted that documented progression is the standard that determines eligibility for crosslinking for patients in their area (NHS Greater Glasgow and Clyde, Scotland). The average time between initial presentation to crosslinking treatment over the review period in the study was 1 year; the authors also noted significant delays between “time of listing to delivery of treatment,” which they said is a source of unrecognized progression. With younger patients likely to have unrecognized visual and topographic changes before even their initial referral, the study authors described how applying a crosslinking recommendation upon initial presentation could have affected the cohort in the study. Fifty-six eyes, they wrote, could have avoided significant topographic changes or mean visual acuity loss had crosslinking been performed prior to documented progression. It also would have resulted in 140 avoided consultations, which could have equated to a cost savings of £18,900. The authors noted that such a policy change would have resulted in 28 potentially unnecessary crosslinking procedures, which they said have a 3% risk of complications. The authors advocated for more validated research to identify patients at their initial visit who are more likely to progress and thus could benefit from immediate crosslinking. The research is published in the journal Eye.

Product news
  • Bausch + Lomb launched Alaway Preservative-Free (ketotifen fumarate) ophthalmic solution, which the company states provides up to 12 hours of antihistamine, eye itch relief.
  • Allergan introduced over-the-counter REFRESH DIGITAL, an eye drop that the company stated is formulated for dry eye related to prolonged screen time.
  • Topcon Healthcare launched a new Glaucoma Module for its Harmony Clinical Data Management Solution, which, according to the company, allows eyecare professionals to access glaucoma diagnosis and management information on a single screen.
  • Alcon’s once-daily Pataday (olopatadine hydrochloride ophthalmic solution) is now available over the counter in stores and online from U.S. retailers.

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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