EW Weekly, July 31, 2020

Diopter range extended for small aperture IOL
The diopter range for the IC-8 small aperture IOL (AcuFocus) now extends from +10 D to +30 D in 0.5 D steps, according to a company press release. The technology is a combination of a clear, aspheric monofocal lens with a mini-ring/pinhole in the center that allows for a range of vision from near to far. IC-8 has the CE mark and is in clinical trials in the U.S. as it moves toward seeking FDA approval.

Positive Phase 2b results in retinitis pigmentosa regenerative medicine therapy
jCyte announced positive results from its Phase 2b trial of jCell, a first-in-class investigational therapy for retinitis pigmentosa that has an FDA Regenerative Medicine Advanced Therapy designation. In the trial, 84 patients (74 included in the final analysis) who were between 20/80 and 20/800 were randomized to receive jCell Therapy, which included 3 million or 6 million human retinal progenitor cells (hRPC) or sham injected intravitreally. Mean change in BCVA at 12 months from baseline was +2.81, +2.96, and +7.43 letters in the sham (N=26), 3 million hRPC (N=25), and 6 million hRPC (N=23) treatment groups, respectively. The company reported improvements in the 6 million hRPC subgroup compared to the control in all secondary endpoints. There was only one serious adverse event in the 3 million hRPC treatment group and none greater than mild in the 6 million hRPC group. According to a press release, based on these results jCyte will initiate a pivotal trial in 2021.

Phase 2 results for dexamethasone intravitreal implant for macular edema
Aerie Pharmaceuticals announced positive Phase 2 results for its AR-1105 dexamethasone intravitreal implant for patients with macular edema associated with retinal vein occlusion. The multicenter study included 49 patients. Safety of one clinical formulation (five patients) was first evaluated and 44 patients were randomized to receive one of two clinical formulations. According to the company press release, both formulations were well tolerated with adverse events consistent with other corticosteroid treatments and similar intravitreal procedures. Aerie also reported an increase in BCVA and reduction in macular edema with peak efficacy observed earlier with clinical formulation-1 but longer overall duration (up to 6 months) with clinical formulation-2.

Phase 3 trials planned for topical drug to treat pain/inflammation and diabetic macular edema
Oculis S.A. announced its successful end-of-phase 2 meeting with the FDA for OCS-01 for treating pain/inflammation after cataract surgery and for treating diabetic macular edema. The company’s press release stated that it is now planning Phase 3 trials for the first half of 2021 to assess OCS-01 for these indications.

Results from two company-led wet AMD studies
Novartis and Genentech both have recent studies involving treatments for wet AMD. Novartis announced post-hoc analysis from its Phase 3 HAWK and HARRIER pivotal trials with Beovu (brolucizumab), showing faster sustainable fluid control compared to aflibercept. Genentech released details from its Phase 3 Archway study that evaluated its investigational Port Delivery System of ranibizumab, finding that 98.4% of patients with this delivery system were able to go 6 months without standard, monthly ranibizumab injections.

Michael Chiang, MD, named director of National Eye Institute (NEI)
The National Institutes of Health (NIH) announced Michael Chiang, MD, as the new director of the National Eye Institute. Dr. Chiang is currently the Knowles Professor of Ophthalmology & Medical Informatics and Clinical Epidemiology at Oregon Health & Science University and associate director of the Casey Eye Institute. The NIH press release noted that Dr. Chiang will assume his role as NEI director in late 2020, stepping in for Santa Tumminia, PhD, who has served as acting director since October 2019.

Research highlights
  • A commentary published in the journal Eye detailed a survey of cataract surgery patients at a single institution in the U.K. who were/are on a wait list for the procedure during the pandemic. A total of 376 patients were contacted for a survey from May 20–June 5 with 55% of them completing it. The survey found that 64.8% of patients agreed/strongly agreed that their quality of life was reduced due to their eyesight and 70% were ready to have surgery within a month. About 27% said they preferred postponing cataract surgery until there are no more cases of COVID-19 or a vaccine becomes available, even if this meant waiting more than 6 months. Nearly 31% said they wouldn’t attend surgery because the person who would accompany them for the procedure was worried about COVID-19. About a quarter (26.6%) were interested in immediately sequential bilateral cataract surgery.
  • There were no differences in visual acuity, refraction, adverse events, and patients’ perspective on their outcomes when comparing FLACS to conventional phaco cataract surgery in a single-center, prospective, single-masked, randomized, case-controlled trial. The research published in the British Journal of Ophthalmology by Stanojcic et al. included 234 patients (116 FLACS and 118 conventional phaco) with 12 months of follow-up. One difference the study authors noted was in femtosecond laser-assisted astigmatic keratectomies vs. manual limbal relaxing incisions; a greater correction index was noted in the former vs. the latter.
  • For the first time researchers acquired OCT images showing the curved layers of the cornea at the cell level. According to a news release from the Optical Society about the research published in the journal Optica, the new instrument used for this imaging could improve monitoring of diseases that alter corneal nerve density. The published paper describes the technology as “curved-field optical coherence tomography.” It was used in vivo and was able to capture a viewing area 10 times larger than current “state-of-the-art” technology. The authors report that the technology is non-contact, compact, and works in a single fast shot (3.5 milliseconds).

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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