EW Weekly, July 17, 2020

Synthetic cornea to begin in-human clinical trials
According to a press release from CorNeat Vision, the CorNeat KPro has been approved to begin clinical trials, starting in Israel. Described as a synthetic cornea that bio-integrates with the eye wall after it is placed under the conjunctiva, the CorNeat KPro trial in Israel will include 10 patients who are corneally blind and who either are not candidates for traditional corneal transplantations or who have failed one or more corneal transplants. The company reported that additional trial sites in Canada, the U.S., France, China, and the Netherlands will open later this year.

FDA approves first OTC, once-daily allergy itch relief drop
Alcon announced FDA approval for over-the-counter (OTC) use of Pataday Once Daily Relief Extra Strength (olopatadine 0.7%), making it the first 24-hour drop available without a prescription in the U.S., according to the company. According to a company press release, the drop will be available online in September and in retail stores in early 2021.

Survey: Glaucoma patients concerned over care during COVID-19 pandemic
A survey, supported by Aerie Pharmaceuticals, of more than 1,000 glaucoma patients from the Glaucoma Research Foundation’s database found that about a third (36%) were either “somewhat confident” or “not confident” about management of their disease during the COVID-19 pandemic. Fifty-three percent reported needing to delay or cancel a glaucoma appointment early in the pandemic. Patients were most concerned about their vision getting worse, not receiving an in-person appointment with an eye doctor, not receiving a quality appointment if they had one in person, and not managing IOP. The survey, which was conducted in May, found at that time that most patients (68%) preferred to be seen in person when offices reopened; 4% preferred a telemedicine visit and 28% would choose a telemedicine visit if their doctor advised it. The survey found 87% of patients would choose to wait 6 weeks for an in-person visit rather than wait 2 weeks for a telemedicine visit. Sixty-three percent of respondents said they were “somewhat comfortable” or “extremely comfortable” returning to in-office care with safety measures in place to reduce exposure.

TearLab acquired by Accelmed Partners II
Accelmed Partners II finalized its acquisition of TearLab. Under this private company, the press release from the company stated, TearLab would continue its development of its next-generation Discovery platform and other opportunities within the dry eye disease market.

AAO announces virtual Annual Meeting
AAO announced this week that it would not be holding its annual meeting, scheduled for November 13–16 in Las Vegas, Nevada, in person due to the ongoing coronavirus pandemic. AAO will host a virtual meeting around the same timeframe, according to a press release.

Register for the Winning Pitch Challenge
ASCRS is hosting the Winning Pitch Challenge symposium on Saturday, July 18 at 2 p.m. ET. The Winning Pitch Challenge features entrepreneurs who share their innovative ideas that could advance ophthalmology with leading experts in the field. The winner receives $25,000 and expert guidance as they try to bring their concept to fruition. Moderators will be Vance Thompson, MD, and Edward Holland, MD. Judges will be William Link, PhD, Richard Lindstrom, MD, Juliet Bakker, and Jim Mazzo. Click here to register for the event.

Research highlights
  • A prospective, randomized, contralateral eye study from a single practice compared a combined therapy (prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac sodium 0.075%, LessDrops, Imprimis) to a conventional regimen of single drops being used. The research by Kerry Solomon, MD, and coinvestigators included 33 patients who used LessDrops in one eye and single drops in the other after cataract surgery. The researchers reported similar changes in central macular thickness, no differences in visual acuity, corneal edema, and cells or flare. They also noted eight mild adverse events in total but stated that the difference between the groups on this front was not statistically significant. From a subjective standpoint, Solomon et al. wrote that patients preferred the combination drop. “A combination drop showed similar efficacy to multiple drops and was overwhelmingly preferred by subjects,” Solomon et al. concluded in the research published in Clinical Ophthalmology.
  • A retrospective case series described continued evolution of maculopathy associated with pentosan polysulfate sodium (PPS) even after the drug has been stopped, out to 10 years. The research published in JAMA Ophthalmology found that long-term use of this drug, FDA approved since 1996 for interstitial cystitis, was previously linked with maculopathy. This case series of 11 patients included baseline measurements taken 0–4 months after stopping the drug with observation for a median of 8–26 months. According to Rachel Shah, MD, and coauthors, no eyes in the case series saw a significant improvement in macular disease after stopping the drug. In fact, nine of the patients (92%) had worse visual symptoms at their final study visit. “There was evolution in the pattern of fundus autofluorescence changes and/or optical coherence tomography findings in all eyes,” the authors wrote, noting an expansion of tissue involved in 77% of eyes and retinal pigment epithelium atrophy at baseline, followed by continued atrophy, in 32% of eyes. “These retrospective data among 11 patients suggest PPS-associated maculopathy continues to evolve after drug cessation for at least 10 years. In some cases, progressive retinal pigment epithelium atrophy encroaches on the foveal center and thus may pose a long-term threat to central vision,” Shah et al. concluded.
  • Twenty-two astronauts in a cohort study had pre- and post-space flight MRIs to evaluate changes in their optic nerve length. The research by Anders Wahlin, PhD, and coinvestigators used MRI to generate centerline representations of the optic nerve, which showed an increase in optic nerve length by 0.80±0.74 mm. The researchers observed forward optic nerve head displacement, which they wrote was “positively related to mission duration, pre-flight body weight, and clinical manifestations of [spaceflight–associated neuro-ocular syndrome (SANS)].” They also reported upward displacement of the optic chiasm, which they wrote is indicative of brain movement, but it was not linked to SANS. “The spaceflight-induced optic nerve lengthening and anterior movement of the optic nerve head supports that SANS is caused by an altered pressure difference between the brain and the eye leading to a forward push on the posterior of the eye. Body weight is a potential contributing risk factor. To verify the implicated mechanism behind the ocular findings in SANS requires direct assessment of intracranial pressure in space,” Wahlin et al. concluded. The research is published in Ophthalmology.

Product news
  • SimulEYE launched BIO Shield, a clear, plastic shield that attaches via magnets to several indirect ophthalmoscope models, adding to its line of other PPE products.
  • The SCHWIND ATOS femtosecond laser (SCHWIND eye-tech-solutions), which performs refractive surgery via lenticular extraction, received the CE mark.

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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