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Quick Notes: May 26, 2023

Sight Sciences releases 2-year study results that show sustained reductions in IOP and glaucoma medication use in mild-moderate POAG patients treated with a procedure with the OMNI Surgical System; Oculis reports positive topline results from DIAMOND Stage 1 Phase 3 Trial in diabetic macular edema with OCS-01 eyedrops; and more.

Ophthalmology Management May 26, 2023

  • Sight Sciences announced the publication of 2-year results of the ROMEO study in Clinical Ophthalmology. The longest multicenter study of the OMNI Surgical System technology to date in both standalone and combination-cataract surgery demonstrated that the significant reductions in IOP and medication usage observed at 12 months were also witnessed at 24 months. In addition, there were no serious or unanticipated adverse events during the length of the 2-year study. Sites participating in this extension study accounted for 86% of eyes enrolled in the original ROMEO study from seven multi-specialty ophthalmology practices in six states. Patients were divided into high baseline IOP (pre-operative IOP >18 mm Hg, n=34) and low baseline IOP cohorts (preoperative IOP ≤18 mm Hg, n=38). Average IOP in the high baseline IOP cohort fell 31% (from 21.9 mm Hg to 15.2 mm Hg) at 2 years, which included an average reduction of 28% among combination cataract patients (n=17) and an average reduction of 33% among standalone patients (n=17). For more, see the study results here.

  • Oculis Holding AG announced positive topline results from Stage 1 of its Phase 3 DIAMOND trial of OCS-01 eyedrops in diabetic macular edema (DME). The primary objective of Stage 1 was to select the optimal dosing regimen. Stage 1 was conducted in 39 sites across the United States and Europe with 148 patients randomized 2:1 to receive OCS-01 (n=100) or vehicle (n=48) six times daily for a 6-week loading phase and then three times daily for a subsequent 6-week maintenance phase. Stage 1 met the primary efficacy endpoint with a statistically significant improvement in mean BCVA “Early Treatment Diabetic Retinopathy Study” chart (BCVA ETDRS) score from baseline to Week 6 vs vehicle (OCS-01: 7.2 letters vs vehicle: 3.1 letters, p=0.007) demonstrating strong visual gain in the treatment arm. The effect was sustained to Week 12 with statistical significance (OCS-01: 7.6 letters vs vehicle 3.7 letters, p= 0.016). For more results from the trial, click here.

  • Alimera Sciences completed enrollment for the company’s NEW DAY clinical trial, a multicenter, single-masked, randomized, controlled trial study designed to generate prospective data for ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg as a baseline therapy in patients diagnosed with DME. The study currently has enrolled approximately 300 treatment-naïve, or near naïve, DME patients in approximately 42 sites across the United States. The primary outcome measure for the NEW DAY Study is the mean number of supplemental aflibercept injections needed during the trial between treatment groups. Key secondary endpoints include mean BCVA score over time, time to first supplemental treatment, measures of retinal thickness variability based on optical coherence tomography and diabetic retinopathy scores. Full study details are available here.

 

  • iHealthScreen Inc. submitted a 510(k) application to the FDA for its iPredict AI Eye Screening System that provides fully automated AMD screening, including retinal imaging and immediate reporting of actionable results. Using the iPredict System, primary care and various specialty practices can accurately and efficiently screen people over 50 for AMD and refer them to an ophthalmologist. Once high-resolution images of the patient’s eyes have been captured using a color fundus camera and submitted to the iPredict AI System, the screening results are available in a fully automated report in less than 60 seconds. The entire test can easily and reliably be completed within 5 minutes.

 

  • The CDC reported more cases of vision loss and a death due to the extensively drug-resistant strain of Pseudomonas aeruginosa found in some artificial tears. The CDC urged patients to immediately stop using and discard EzriCare Artificial Tears, Delsam Pharma Artificial Tears and Delsam Pharma Artificial Ointment pending additional information and guidance from the CDC and FDA. As of May 15, 2023, CDC, in partnership with state and local health departments, identified 81 patients in 18 states (Calif., Colo., Conn., Del., Fla., Ill., N.C., N.J., N.M., Nev., N.Y., Ohio, Pa., S.D., Texas, Utah, Wash., Wis.) with VIM-GES-CRPA, a rare strain of extensively drug-resistant P. aeruginosa. This represents an increase of 13 patients since the last update — six had specimens collected prior to the Feb. 2, 2023, manufacturer recall of products associated with this outbreak. Of the seven patients who had specimens collected after the recall, most either resided in long-term care facilities with other known cases or reported use of a recalled brand of artificial tears. Adverse outcomes that were associated with clinical cultures and reported to public health include 14 patients with vision loss, an additional four patients with enucleation, and four deaths within 30 days of VIM-GES-CRPA clinical culture collection. Patients reported over 10 different brands of artificial tears, and some patients used multiple brands. EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles, was the brand most commonly reported. This was the only common artificial tears product identified across the four health-care facility clusters. Read the full statement here.

 

  • Researchers at the Wayne State University School of Medicine have provided evidence that depletion of a certain protein in the body can treat age- and diabetes-induced retinal diseases. The protein, called vascular cell adhesion molecule (VCAM1), intercedes the adhesion of white bloods cells’ lymphocytes, monocytes, eosinophils and basophils to vascular endothelium and induces pathological retinal angiogenesis, which can lead to blindness. The researchers found that VCAM-1 controls angiogenesis in human retinal microvascular endothelial cells by increasing the expression of IL-8, a potent promoter of angiogenesis. Their findings in a murine model of oxygen-induced retinopathy show that lowering VCAM1 levels reduces aberrant blood vessel development in the retina. These findings imply that VCAM1 antagonism could be a promising therapeutic strategy for proliferative retinal disorders. For more, see the study results here.

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.