Even as the COVID-19 pandemic rages, news in ophthalmology doesn’t stop. Retina Today collected these news items unrelated to the COVID-19 crisis.
Surgery Combined With tPA Injection Improved Vision After Submacular Hemorrhage
In patients with fovea-involving subretinal macular hemorrhage from a range of causes, pars plana vitrectomy (PPV) combined with injection of tissue plasminogen activator (tPA) and pneumatic displacement of the hemorrhage improved visual outcomes, a retrospective study found.1 Reviewing all patients (N = 37) with submacular hemorrhage who underwent PPV with subretinal tPA injection at the New York Eye and Ear Infirmary of Mount Sinai, the authors found that 61% of patients experienced some form of vision improvement, and 42% gained 3 or more lines of vision at 3 months’ follow-up. Pathologies represented in the patient population included exudative macular degeneration, undifferentiated choroidal neovascularization (CNV), polypoidal choroidal vasculopathy, traumatic CNV, and proliferative diabetic retinopathy.
“This study comprises the most diverse patient cohort reported of subretinal macular hemorrhage treated with PPV and subretinal tPA, with no significant difference in outcome found between subgroups,” the study authors stated.
1. Wilkins CS, Mehta N, Wu CY, Barash A, Deobhakta AA, Rosen RB. Outcomes of pars plana vitrectomy with subretinal tissue plasminogen activator injection and pneumatic displacement of fovea-involving submacular haemorrhage. BMJ Open Ophthalmol. 2020;5(1):e000394.
RNA Therapy for Usher Syndrome Showed Signs ofEfficacy in Interim Analysis
An investigational RNA therapy was safe and showed signs of efficacy in two of eight patients treated in a planned interim analysis of a phase 1/2 clinical trial, the therapy’s developer announced in March. The clinical trial of QR-421a (ProQR Therapeutics) includes patients with Usher syndrome and with nonsyndromic retinitis pigmentosa (nsRP) due to USH2A exon 13 mutations. The Stellar trial is a randomized, single-ascending-dose, multicenter longitudinal 24-month study comparing active versus sham procedures. In the interim analysis of a total of 14 patients in two cohorts (3-month results of cohort 2 and 9-month results of cohort 1), one treated patient in each cohort “demonstrated benefit across multiple concordant outcome measures,” the company said in a press release.
In the same release, the company noted that it expects delays in this and other clinical trials due to disruptions caused by the COVID-19 pandemic. The company said it plans to resume dosing patients as soon as it is practical to do so.
New Leadership Positions at Two Ophthalmic Companies
Two companies involved in ophthalmic drug development, Iveric bio and Clearside Biomedical, announced leadership changes in March.
Iveric bio announced the appointment of Pravin Dugel, MD, as its executive vice president and chief strategy and business officer, effective April 1. In this role, Dr. Dugel will help shape Iveric bio’s business development strategy and will report to Glenn P. Sblendorio, the company’s chief executive officer and president. The company is developing avacincaptad pegol (Zimura), a complement factor C5 inhibitor, for the treatment of geographic atrophy in patients with dry age-related macular degeneration (AMD).
Dr. Dugel was previously managing partner at Retinal Consultants of Arizona and the Retinal Research Institute; a clinical professor at the USC Eye Institute, Keck School of Medicine, University of Southern California; and a founding member of Spectra Eye Institute in Sun City, Arizona. He is a member of Retina Today’s Editorial Advisory Board.
Clearside Biomedical announced that George Lasezkay, PharmD, JD, was appointed president and CEO and will continue to serve on the company’s board of directors, effective March 1. He had been the company’s interim CEO since April 2019. Clearside is developing triamcinolone acetonide for suprachoroidal injectable suspension (Xipere), which was licensed by Bausch + Lomb in October of last year. The company expects to resubmit its new drug application for the drug to the US FDA in the first quarter of 2020 and believes the FDA will review the submission within 6 months of receipt.
Enrollment Complete in Adult Dose Groups in Achromatopsia Phase 1/2 Trials
Planned enrollment has been completed in all adult dose groups in phase 1/2 clinical trials of gene therapies for patients with achromatopsia due to mutation in the ACHM CNGB3 or ACHM CNGA3 genes, trial sponsor Applied Genetic Technologies Corporation (AGTC) announced in March. The company reported interim 6-month data from the dose-escalation cohorts of its ongoing ACHM phase 1/2 clinical trials in January. Results in both studies demonstrated encouraging signs of biologic activity, the company said in a press release. AGTC plans to report interim data from all adult dose groups in the second half of 2020 and to use the data to inform decision-making regarding moving to phase 3 trials.
Case Report: Cholesterol-Lowering Drug May Cause Scleritis
The cholesterol-lowering drug alirocumab (Praluent, Regeneron) may cause scleritis with uveal effusion, according to a case report in Annals of Internal Medicine.1
Alirocumab is a human monoclonal antibody that increases the expression of low-density lipoprotein receptor and decreases levels of low-density lipoprotein cholesterol. It is used as a second-line treatment for adults whose high cholesterol levels are not controlled by diet and statin treatment.
“The case we report here is unusual, because alirocumab-induced scleritis seems to be rare but also because alirocumab does not target a molecule in the immune pathway,” the report’s authors said. “We believe that our patient’s complex autoimmune history, which includes thyroiditis and antinuclear antibodies, may have predisposed her to this reaction. We also believe that additional cases may be expected with the general increase in monoclonal antibody therapy.”
1. Breazzano MP, Chen RWS. Scleritis with uveal effusion from alirocumab [published online ahead of print March 10, 2020]. Ann Intern Med.
Retina Group of Washington Now Affiliated with Prism Vision Group
Prism Vision Group in March announced an agreement to add a new partner, the Retina Group of Washington, a provider of retinal and macular care in Washington, DC; Virginia; and Maryland. Terms of the deal were not disclosed.
Prism Vision Group is a physician-led organization that provides comprehensive support services to eye care organizations. The Retina Group of Washington includes 32 physicians practicing at 17 locations.
FDA Approved Sustained-Release Bimatoprost for Glaucoma
The FDA in March approved Allergan’s new drug application for its bimatoprost implant 10 mcg (Durysta). The implant is the first intracameral biodegradable sustained-release implant indicated to reduce IOP in patients with open-angle glaucoma or ocular hypertension, according to Allergan. The FDA approval was based on results from the two 20-month (including 8-month extended follow-up) phase 3 ARTEMIS studies, in which the implant reduced IOP by approximately 30% from baseline over the 12-week primary efficacy period.