EW Weekly, March 12, 2021

FDA approves elements of artificial vision system for blind patients
The FDA approved the Argus 2s Retinal Prosthesis System (Second Sight Medical Product), which the company explained is a redesigned set of external hardware that will be used with Second Sight’s Orion Visual Cortical Prosthesis System. According to the company’s press release, production of the hardware and advancement of other products is pending a business combination with Pixium Vision. The original Argus II System is designed to bypass dysfunctional retinal cells with electrical stimulation to remaining viable cells to allow visual perception in patients with retinitis pigmentosa. Images are captured by a camera mounted on glasses, which are then translated to electrical pulses onto an array of electrodes implanted on the patient’s retina, resulting in visual patterns of light that the patient learns to interpret, according to the company’s press release. The Orion Visual Cortical Prosthesis System, which is intended to work with the newly approved external hardware, functions similarly to the original Argus II System but is implanted on the surface of the brain’s visual cortex and is intended for individuals who are blind due to glaucoma, diabetic retinopathy, optic nerve injury or disease, and more. A small feasibility study with this is in progress.

Expanded indication for MIGS device
Sight Sciences announced that the FDA approved expanded labeling for the OMNI Surgical System to include it as a standalone procedure for patients with POAG. The press release explained that most MIGS procedures for mild to moderate POAG are approved in combination with cataract surgery, but only about 10% of patients with POAG in the U.S. need this combination with cataract surgery. The OMNI Surgical System performs canaloplasty (viscodilation of Schlemm’s canal) followed by trabeculotomy.

5-year pivotal trial data for MIGS device
Ivantis announced 5-year pivotal trial data for its Hydrus Microstent. The company’s press release called this “the longest continuous follow-up of a MIGS device pivotal trial.” The data, which was first presented at the virtual meeting of the American Glaucoma Society, confirmed long-term safety and durability of the stent. The company’s press release reported that 73% of patients who were on one glaucoma medication at baseline remained medication-free at 5 years after receiving Hydrus in combination with cataract surgery (48% of patients in the cataract surgery alone group were medication-free at this timepoint). Patients needing more invasive glaucoma surgery in this timeframe were lower in the group that received Hydrus (2.5% compared to 6.4% in the cataract surgery alone group). This is a 60% reduction in the likelihood of needing subsequent invasive glaucoma surgery, according to the company. Safety, including endothelial cell counts and persistent inflammation, was similar between the Hydrus and control groups.

Topline results from Phase 2 study of investigational MGD treatment
Azura Ophthalmics announced with the release of topline data that primary endpoints were met in its Phase 2 study of AZR-MD-001 as a treatment under investigation for MGD. Patients (n=95) were dosed twice weekly with AZR-MD-001 (0.1%, 0.5%, or 1.0%) or control with patient-reported symptoms, OSDI score, meibomian gland secretion quality (Meibomian Gland Score), and number of glands secreting (Meibomian Glands Yielding Liquid Secretion Score) recorded at various time points. According to the company’s press release, there was a statistically significant improvement from baseline in the 0.5% and 1.0% dose groups and significant improvement over the control group at month 3 in the 0.5% group. Overall, the company reported 58% of patients becoming non-symptomatic after 3 months with AZR-MD-001 treatment compared to 16% in the control group.

Research highlights
  • Researchers recently published a paper that describes a safe, noninvasive method to image rods and cones of the eye in vivo. Published in the journal Optica, the research sought to obtain high-resolution images of photoreceptors, which can be a challenge due to distortion of light from optical elements and safety issues for imaging beyond the diffraction barrier of light in the living eye. The investigators created a ring-shape light beam to improve resolution of photoreceptor imaging and used a small pinhole to address depth of resolution. This technique was tested on healthy volunteers where it was found to increase transverse resolution by 33% and axial resolution by 13% compared to adaptive optics scanning light ophthalmoscopy. The technique demonstrated the ability to image some subcellular structures. According to a press release about the research, this technique could improve observational efforts to determine how cells change over time, an especially useful tool when evaluating new treatments to prevent blindness.
  • A randomized study sought to compare intraoperative mydriasis achieved with topical nepafenac or flurbiprofen. All patients received one drop of tropicamide and phenylephrine (combination) four times every 15 minutes preoperatively. Afterward, the group was divided equally to receive either nepafenac or flurbiprofen four times at a 15-minute interval. Phaco was performed 1 hour after the last drop was administered. The vertical and horizontal diameter of the pupil at the start of surgery was similar. However, after the nucleus was removed and at the end of surgery, there was a significant difference. The researchers saw less reduction in pupil diameter in the nepafenac group, leading the authors to conclude that nepafenac was more effective at maintaining intraoperative mydriasis during the procedure than flurbiprofen. This research is published in the journal Clinical Ophthalmology.
  • Spectacle independence, patient-reported outcomes, and dysphotopsias were compared in a group of patients (n=59) who received the AcrySof PanOptix trifocal (Alcon) bilaterally and a group of patients (n=191) who received either the AcrySof ReSTOR (Alcon) +2.5/3.0 D or AcrySof ReSTOR ActiveFocus +2.5 with mini-monovision IOL. The report published in Clinical Ophthalmology showed that 83% of patients with PanOptix “never” needed glasses compared to 36% of those in the ReSTOR mini-monovision and 34% in the ReSTOR +2.5/3.0 group. There was no significant difference in patient satisfaction or BCVA. Glare and halo were more likely to be rated “extremely noticeable” in the PanOptix group (10%) compared to 1% in the ReSTOR mini-monovision group and 3% in the ReSTOR +2.5/3.0 group.

Product news
  • Verkazia (Santen, cyclosporine topical ophthalmic emulsion), approved in Canada for severe vernal keratoconjunctivitis, is now reimbursable in Quebec.

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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