EW Weekly, March 19, 2021

FDA accepts IND for presbyopia-correcting eye drop
Visus Therapeutics announced FDA acceptance of an IND application for its presbyopia-correcting eye drop, BRIMOCHOL. BRIMOCHOL is described as a combination of carbachol and brimonidine tartrate designed for once daily use. According to the company’s press release, with this IND it plans to begin a Phase 2 clinical trial immediately. To date, six clinical studies involving more than 200 patients have demonstrated safety and efficacy of the investigational drop, the company stated.

Pivotal study of new tech against gold standard patching treatment of amblyopia
NovaSight, a medical startup, is beginning a clinical trial to test a new technology-based treatment for amblyopia against eye patching, the current standard of care. According to the company’s press release, the study is recruiting 90 children with amblyopia to participate in the pivotal trial to test its CureSight digital treatment device. The device is based on eye tracking with real-time image processing. A previous pilot trial with the technology included 20 patients. The technology had a 95% adherence rate and showed significant improvement in visual and stereo acuity with results stable out to 6 months.

Topline results from trial to reverse pharmacologically induced mydriasis
Ocuphire Pharma announced positive primary and secondary topline results from a Phase 3 registration trial of its product candidate to reverse pharmacologically induced mydriasis. Nyxol (phentolamine mesylate) in the MIRA-2 trial demonstrated the ability to return pupils to ≤0.2 mm of baseline within 90 minutes in 49% of study participants compared to 7% of subjects treated with placebo. Three common mydriatic agents were used to induce pupil dilation in the trial and Nyxol was effective regardless of the agent used. Pupil diameters were 1–2.5 mm smaller in the study group compared to those treated with placebo at all time points (1–6 hours after dosing). There were no serious adverse events; mild, transient conjunctival hyperemia occurred in Nyxol-treated subjects, peaking at 1 hour and decreasing thereafter. The company announced that full results will be shared at the upcoming 2021 ASCRS Annual Meeting.

Pivotal study of fixed-combination tropicamide/phenylephrine product for mydriasis
Eyenovia announced publication of pooled data from its Phase 3 clinical trials of a micro-dosed fixed combination of tropicamide and phenylephrine for mydriasis. It was found safe and effective with a clinically relevant and statistically significant outcome vs. either agent alone or placebo, the company reported. Published in Therapeutic Delivery, 93% of eyes in the study that received the fixed-combination micro-dosed compound achieved 6 mm or greater dilation at 35 minutes compared to 78% with tropicamide or 2% with phenylephrine alone. Adverse events occurred in 3% of cases with the combined compound and were mild, according to the company’s press release; 1% of patients experienced blurred vision, reduced acuity, photophobia, or pain.

ASCRS introduces new Richard L. Lindstrom Lecture
The inaugural Richard L. Lindstrom Lecture will be delivered at the 2021 ASCRS Annual Meeting in Las Vegas, Nevada. The distinguished lecture was established to honor the contributions Dr. Lindstrom has made to the society and ophthalmology over the last 40-plus years. Dr. Lindstrom has had an impact on all subspecialties of anterior segment surgery and has played an active role in fostering collaboration with industry to advance the field. The ophthalmologist selected to deliver the Lindstrom Lecture on July 25 will be an individual who has made significant contributions to an area of Dr. Lindstrom’s ophthalmic interests.

Research highlights
  • One-year outcomes of preloaded DMEK vs. non-preloaded DMEK cases were compared in a study published in Cornea. The retrospective comparative cohort study included eyes with Fuchs (n=68) who had DMEK surgery with graft tissue preloaded (n=38) or not preloaded (n=30). The surgeries were performed by cornea fellows with an experienced surgeon between 2016–2018. CDVA between the two groups was similar. More preloaded DMEK eyes (66%) achieved a visual acuity of ≥0.1 logMAR compared to eyes in the non-preloaded group (57%). Most eyes in both groups (95% and 97%, respectively) achieved a CDVA ≥0.3 logMAR, according to the study authors. There was no difference between the groups in terms of central corneal thickness or post-processing endothelial cell count. The need for rebubbling was lower in the preloaded group (13.16%) vs. the non-preloaded group (33.33%). With these results, the investigators concluded that preloaded tissue from eye banks is useful in DMEK procedures.
  • Real world treatment of dry eye disease with lifitegrast (Xiidra, Novartis) was evaluated via chart data analysis of hundreds of patients in a study published in Clinical Ophthalmology. Five hundred and fifty-four patients had follow-up out to 6 months post-initiation of treatment with lifitegrast, and 281 patients had follow-up out to 1 year. Of those with data out to 6 months, 92.4% were still taking lifitegrast and 84.7% of patients were still taking it at 1 year. The researchers noted a decrease in other dry eye-related treatments that had been taken prior to or concurrently with lifitegrast. Over-the-counter artificial tear use decreased from 75.5% to 45.2% in patients who used lifitegrast, topical corticosteroids decreased from 19.8% to 3.8%, and cyclosporine use decreased from 20.5% to 3%. The researchers noted reduced dryness, blurred vision, ocular burning/stinging, depression, fatigue, and headache in this patient population. They also reported reduced corneal staining and higher Schirmer scores and tear film break-up times.

Product news
  • Johnson & Johnson Vision introduced a new contact lens option for patients with presbyopia, Acuvue Oasys Multifocal Contact Lens with Pupil Optimized Design, available in the U.S. and Canada.

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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