EW Weekly, June 5, 2020

Cataract Awareness Month
June is Cataract Awareness Month, established by the organization Prevent Blindness. As the leading cause of preventable vision loss worldwide, Prevent Blindness suggests educating on the different types of cataracts, the risk factors for cataract development, and how they can be treated.

Retinal tissue regeneration seen after RPE transplant
Lineage Cell Therapeutics announced retinal tissue regeneration in the Phase 1/2a study of its retinal pigment epithelium (RPE) cell transplant therapy, OpRegen, for dry AMD. According to the company, this finding suggests that at least some part of the diseased tissue could be recovered. The company reported that a patient with atrophic, end-stage dry AMD received an allogenic RPE cell transplant and 9 months later showed geographic atrophy 24% smaller than baseline. The company also reported that the area of atrophy grew at a 50% slower rate. Lineage Cell Therapeutics reported that these findings were observed by an independent, external advisor with multiple technologies and were later confirmed by a reading center and other experts in retinal imaging. According to Lineage Cell Therapeutics, this is the first time results like this have been seen for dry AMD. The trial for OpRegen is ongoing with 17 of 21 patients enrolled.

Phase 3 trial of NCX 470 initiated
Nicox initiated a Phase 3 clinical trial for NCX 470, a second-generation nitric oxide-donating bimatoprost analog, to lower IOP for open angle glaucoma or ocular hypertension patients. The double-masked, parallel group, adaptive design trial will last 3 months, comparing NCX 470 (0.065% and 0.1%) to latanoprost ophthalmic solution (0.005%). The NCX 470 dose that performs the best in this safety and efficacy trial will continue on to a second Phase 3, 3-month, head-to-head trial with latanoprost. The multicenter trial plans to randomize at least 600 patients in the U.S. and China.

Phase 2 clinical trial for novel gene therapy for DME
Adverum Biotechnologies is beginning a Phase 2 clinical trial of ADVM-022 for DME, based on the success of its Phase 1 clinical trial with the same novel gene therapy for treatment of wet AMD. The INFINITY trial for DME will be multicenter, randomized, double-masked, and active comparator controlled to evaluate one intravitreal injection of the gene therapy compared to one aflibercept injection. Worsening of DME will be measured, in addition to assessment of perceived treatment burden, visual acuity, retinal anatomy, and safety. According to the company, ADVM-022 carries an aflibercept coding sequence in a vector capsid called AAV.7m8. It is designed to reduce the burden of frequent intravitreal injections that would otherwise be required to treat DME.

Phase 3 trial discontinued for drug to treat ocular graft vs. host disease
Ocugen announced the discontinuation of a Phase 3 trial for its drug OCU300 to treat ocular graft vs. host disease, stating that pre-planned interim analysis suggested that the candidate was unlikely to meet primary endpoints. The company emphasized that the trial was not stopped based on safety concerns. OCU300 was a 0.18% ophthalmic nanoemulsion of brimonidine tartrate. Moving forward, the company stated that it is focusing efforts on its gene therapy platform and novel biologic programs.

ASCRS releases new, updated IOL calculators and tools
ASCRS added two new tools and updated an existing tool on its website for surgeons this week. One new tool is the IOL Calculation Formula Analyzer, which generates up to four histograms (based on up to four formulas) of predicted postop spherical equivalent numerical errors. It also shows the percentage of eyes with prediction errors less than or equal to 0.25 D, 0.5 D, and 1 D, mean numerical error, standard deviation, minimal prediction error, maximal prediction error, mean absolute error prediction, and median absolute prediction error. Instructions for this tool are on the website. ASCRS also released the Corneal SIA Tool and instructions. This tool generates double-angle plots of corneal surgically induced astigmatism. The Astigmatism Double Angle Plot Tool and instructions received an update. Check out the new, updated, and existing tools on the ASCRS tools and calculators webpage.

ASCRS and IJCAHPO Technicians & Nurses Program virtual broadcast
Technicians and nurses are encouraged to join a virtual broadcast series of topics from the 2020 Technicians & Nurses Program sponsored by IJCAHPO and ASCRS. The program will have the latest information on cataract and refractive surgical topics with the potential to earn up to 21 IJCAHPO credits over 3 days. Part 1 and 2, which are purchased together with the potential for up to 14 IJCAHPO credits, will take place June 6 from 8:00 a.m.–5:00 p.m. CDT and June 13 from 8:00 a.m.–5:00 p.m. CDT. Part 3, purchased separately, will take place June 27 from 8:00 a.m.–5:00 p.m. CDT for the potential of up to 7 IJCAHPO credits.

Research briefs
  • A prospective, observational case series of 29 eyes of 29 patients evaluated the utility of ultrasound biomicroscopy (UBM) for assessing pseudophakic glaucoma after cataract surgery. The research by Ragab et al. described how UBM could be used to determine the cause of pseudophakic glaucoma. In this case series, UBM determined the cause to be haptic related in nine cases. Six eyes were found to have decentered or tilted IOLs and three eyes had Soemmering’s ring. One eye had a retained lens particle, and another had silicone oil in the anterior chamber with seclusio pupillae. Eight eyes had peripheral anterior synechiae, while seven had posterior synechiae. According to the research, which is published in Clinical Ophthalmology, three eyes with an anterior chamber IOL had uveitis and one eye had peripheral anterior synechia attributable to neovascular glaucoma.
  • Four different smartphone-based fundus imaging systems were evaluated for diabetic retinopathy screening purposes. The research compared the use of these technologies to conventional fundus photography and clinical exams. Ultimately, Wintergerst et al. found that while smartphone-based systems could meet screening requirements in outreach settings, diagnostic accuracy for most systems was subpar compared to the standard. The smartphone system based on indirect ophthalmoscopy had the best image quality, largest field of view, and longest examination time, according to the researchers. The system based on indirect ophthalmoscopy (compared to the smartphone systems that had a direct ophthalmoscopy approach) also showed the highest agreement with the reference standard. The study is published in the journal Ophthalmology.

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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