EW Weekly, April 3, 2020

Ocular abnormalities in patients with COVID-19
According to a study published online in JAMA Ophthalmology, one-third of patients with COVID-19 had ocular abnormalities. Abnormalities, which included conjunctival hyperemia, chemosis, epiphora, and increased secretions, were more frequent in patients with more severe COVID-19 conditions. The research by Wu et al. included 38 patients treated for COVID-19 from Feb. 9–15, 2020, at a hospital in China’s Hubei province. Wu et al. also wrote that while the prevalence of SARS-CoV-2 is low in tears, ocular secretions can transmit the virus.

Zerviate for allergic conjunctivitis launched in the U.S.
Eyevance Pharmaceuticals launched Zerviate (0.24%, cetirizine ophthalmic solution) in the U.S. as a treatment for ocular itching associated with allergic conjunctivitis. According to the company, the drug is formulated with Hydrella, a vehicle that includes ingredients common to tear lubricants that make delivery of the cetirizine molecule comfortable to the ocular surface. Eyevance noted that given the COVID-19 pandemic, it deployed a remote virtual selling platform for its team to engage with ophthalmologists and other providers to introduce, educate, and supply Zerviate.

Enrollment complete for two different dry eye treatment clinical trials
Enrollment is complete for two different Phase 3 clinical trials for dry eye treatments. Oyster Point Pharma announced complete enrollment for its pivotal Phase 3 trial for OC-01, a nasal spray to treat the signs and symptoms of dry eye. Separately, Mimetogen Pharmaceuticals announced enrollment completion for its Phase 3 trial for the first-in-class nerve growth factor tavilermide. Oyster Point’s ONSET-2 Phase 3 clinical trial for OC-01 enrolled a total of 758 participants at several U.S. sites. The study is investigating two doses of the spray compared to placebo, evaluating safety and efficacy. The MIM-728 Phase 3 trial by Mimetogen has enrolled 600 patients and will compare efficacy for 5% tavilermide and 1% tavilermide ophthalmic solutions to vehicle (placebo), each dosed two times a day for 12 weeks, according to the company’s press release.

Patient dosing and follow-up complete for Phase 2 trial of OPT-302
Opthea Limited announced completion of patient dosing and follow-up to 12 weeks for a Phase 2a trial evaluating safety and efficacy of OPT-302 in combination with aflibercept (Eylea, Regeneron Pharmaceuticals) to treat diabetic macular edema.

Results from first-in-human artificial retinal device
As part of a multicenter trial enrolling in Europe, Nano Retina announced the results from its first-in-human NR600 artificial retina device, which the company describes as mimicking the eye’s natural physiological processes to restore functional vision of those blind from retinal degenerative diseases. Two patients who were blind from retinitis pigmentosa, according to a company press release, received the device and after activation reported seeing visual effects.

Phase 1/2 data for RNA therapy for Usher syndrome and non-syndromic retinitis pigmentosa
Use of RNA therapy QR-421a (ProQR Therapeutics) benefited 25% of patients, showing up to a line of improved vision compared to the untreated eye, according to interim analysis of Phase 1/2 data. The Stellar trial is a 24-month trial for patients with Usher syndrome or non-syndromic retinitis pigmentosa. QR-421a targets the underlying cause of these rare genetic conditions. There are currently no approved therapies for either.

Positive Phase 2a results for thyroid eye disease treatment
Data from an ongoing Phase 2a proof-of-concept study for IMVT-1401 for thyroid eye disease (Immunovant) showed positive results, with a 65% mean reduction in the antibody IgG from baseline. The subcutaneous injection of anti-FcRn antibody was also well tolerated with no serious adverse events. According to a news release from the company, 57% of patients’ Clinical Activity Score improved by 2 or more points, and 43% of patients had a proptosis response.

COVID-19: News You Can Use
ASCRS 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. The e-newsletter is published as new information relevant to its members emerges.

Research briefs
  • Researchers describe a novel, sutureless intrascleral fixation technique for a single-piece, nonfoldable IOL. The technique, according to Sergio Canabrava, MD, and coauthors, is based on the Malbran IOL fixation technique and the Yamane double-needle intrascleral haptic fixation technique. The new technique involves use of a 5.0 polypropylene suture and cautery to create two flanges in the IOL’s eyelets and two other flanges outside that will then be inserted into a scleral tunnel. The researchers reported the technique on four patients who went from a mean corrected distance visual acuity of 0.45 ± 0.17 Snellen decimal units preoperatively to 0.67 ± 0.27 postoperatively. Overall, the researchers concluded that their technique “improves and simplifies” intrascleral fixation techniques. The research is published in Cornea.
  • Physicians overall are satisfied with current topical anti-inflammatory treatments for dry eye disease (cyclosporine ophthalmic emulsion 0.05% and lifitegrast 5% ophthalmic solution), but according to a 21-physician survey, they say there is still a gap in dry eye disease management, reported Darrell White, MD, and coresearchers. Physicians who took the survey were asked to rate the experiences of patients (210 patients represented) who had used these medications. According to the research published in Clinical Ophthalmology, two-thirds of physicians reported overall satisfaction with efficacy of the cyclosporin and lifitegrast products, but the researchers noted low satisfaction with onset of action, and less than half thought the drugs were effective in managing symptoms or improving patients’ quality of life.
  • Researchers reported the long-term outcomes of SMILE in patients with more than 2 D of myopic astigmatism, showing overall good safety and efficacy of the procedure in a population with high astigmatism. The study assessed the visual and refractive results and corneal wavefront aberrations of a high astigmatism group (≥2.00 D) and a low astigmatism group (≤1.00 D) who had SMILE 4 years prior. Preoperative cylinder was −2.47 ± 0.54 D in the high astigmatism group, and residual astigmatism in this same group 4 years postop was −0.31 ± 0.29 D. Both groups were largely within 0.5 D of cylinder target (86% in the high astigmatism group and 90.3% in the low astigmatism group), found Yuanyuan Zhong, MD, and coinvestigators. The researchers noted a tendency toward under correction for astigmatism in the high astigmatism group. The research appears in the British Journal of Ophthalmology.

Product News

Genentech will extend physician payment terms for Lucentis (ranibizumab) purchases due to the COVID-19 pandemic, according to a press release issued by the American Academy of Ophthalmology.

Allergan is lowering copay savings card offerings for Restasis (cyclosporine), Restasis Multidose, Lumigan (bimatoprost), Combigan (brimonidine/timolol), and Alphagan P (brimonidine). In addition, it is extending payment terms for all Ozurdex (dexamethasone) and XEN purchased directly from Allergan on or before March 23, among other actions as part of its response to the pandemic.

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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