EW Weekly, April 12, 2019

Alcon, Novartis complete separation
Alcon and Novartis completed their separation earlier this week. Alcon shares began to trade on the SIX Swiss Exchange and the New York Stock Exchange under the symbol “ALC.”

Histogenics and Ocugen enter into merger
Histogenics and Ocugen announced that they have entered into a definitive merger agreement, according to a press release from both companies. A merger with Ocugen will enable Histogenics investors to participate in Ocugen’s broader ocular disease pipeline and gene therapy opportunities, according to Histogenics president Adam Gridley. The drug pipeline from Ocugen includes OCU300, an orphan drug candidate for ocular graft-versus-host disease; OCU310 for dry eye; and OCU400, a gene augmentation therapy for patients with inherited retinal diseases caused by NR2E3 gene mutations.

New indication for ILUVIEN approved in the U.K.
ILUVIEN (Alimera Sciences) is now approved in the U.K. for prevention of relapse in recurrent noninfectious uveitis affecting the posterior segment, according to an Alimera press release. The indication could expand to other countries in the European Union, pending regulatory reviews.

Enrollment milestones reached in Phase 1 and 2 clinical trials for gene therapies
Phase 1/2 clinical trials for adeno-associated virus-based gene therapies have reached enrollment milestones in two trials, according to a press release from Applied Genetic Technologies Corporation. Applied Genetics completed enrollment of the dose escalation portion of the achromatopsia CNGB3 trial to evaluate the safety and efficacy of its product candidate to treat achromatopsia caused by CNGB3 gene mutations. Enrollment also was completed in the expansion group of its product candidate to treat X-linked retinitis pigmentosa caused by RPGR gene mutations.

More hospital costs incurred when patients have severe vision loss
A longer mean length of stay, higher readmission rates, and higher costs during hospitalization and 90 days after discharge all were associated with patients who had severe vision loss, reported Alan Morse, JD, PhD, and coresearchers. Their study included 12,330 Medicare beneficiaries and 11,858 commercial health insurance enrollees with or without vision loss. Individuals with vision loss were matched 1:1 with those with no vision loss by age, years from initial hospitalization, sex, race/ethnicity, urbanicity of residence, and overall health. Vision loss was categorized as partial or severe. “When [the] findings were extrapolated to hospitalizations of patients with vision loss nationwide, an estimated amount of more than $500 million in additional costs annually were spent caring for these patients,” according to the researchers. By addressing vision issues, there is an opportunity to lower resource costs and shorten stays, they concluded. The study is published in JAMA Ophthalmology.

Research briefs
  • In a Phase 2a, open-label, multiple-dose study, recombinant human nerve growth factor (rhNGF) eye drops given in two different doses were safe and effective at improving symptoms and signs of dry eye disease, reported Marta Sacchetti and coresearchers. The study included 40 consecutive patients with moderate to severe dry eye. Group 1 received the rhNGF drops at 20 micrograms/mL compared with 4 micrograms/mL. The primary outcomes measures were treatment-emerged adverse events, the Symptom Assessment in Dry Eye scale, ocular surface staining, and Schirmer test results. The frequency and severity of dry eye symptoms and ocular surface damage all had significant improvement in both groups, but tear function improved only in the group receiving the larger concentration. Randomized clinical trials are ongoing to confirm the therapeutic benefit of rhNGF, the researchers wrote. The study is published in the British Journal of Ophthalmology.
  • In a group of patients with fungal or bacterial keratitis, long-term outcomes were similar, but fungal ulcers were more likely to have associated severe visual impairment, according to Namperumalsamy Prajna and coresearchers. Their prospective cohort study included 100 patients from a tertiary eye hospital in India who were diagnosed 4 years prior with fungal or bacterial keratitis and were enrolled in one of two concurrent randomized trials. Presenting visual acuity, best spectacle-corrected visual acuity, and hard contact lens-corrected visual acuity were the main outcome measures. At 4 years, presenting vision in the better eye was worse than 20/60 for 24% of individuals in the fungal group and 20% in the bacterial group. The median best spectacle-corrected visual acuity in the affected eye at 4 years was similar in both the fungal and bacterial groups (Snellen equivalent, 20/32), but vision of worse than 20/400 was more common in the fungal ulcer group after spectacle and contact lens correction. The study appears in the American Journal of Ophthalmology.
  • The cumulative incidence of neodymium:YAG (Nd:YAG) capsulotomy was significantly lower in eyes receiving SN60WF (Alcon) or ZA9003 (Johnson & Johnson Vision) IOLs compared with the ZCB00 (Johnson & Johnson Vision) IOL, reported Juha-Matti Lindholm and fellow researchers. Their retrospective cohort study focused on 5-year cumulative incidence and risk factors of Nd:YAG capsulotomy between hydrophobic acrylic lenses. A total of 10,044 eyes having cataract surgery and in-the-bag implantation of one of the IOL types were included. The overall incidence of Nd:YAG capsulotomy was 13.2% for all eyes and 18.1%, 11.5%, and 9.6% for the ZCB00, SN60WF, and ZA9003 IOLs, respectively. There was an increased risk of Nd:YAG capsulotomy in eyes with patients age 60 or younger, in females, and in eyes with an IOL power of less than 22.5 D. The study is published in the American Journal of Ophthalmology.
  • The use of a single trabecular microbypass stent provided a sustained IOP reduction in pseudophakic patients who had mild to severe open angle glaucoma, reported Tanner Ferguson, MD, and coresearchers. Their retrospective study included 40 patients (51 eyes); patient data were collected preoperatively and at 1 day, 1 week, 1 month, and up to 48 months post-surgery. Data collected included IOP, number of glaucoma medications used, and the need for secondary surgery. The mean IOP lowered from 20.33 mm Hg at baseline to 15.65 mm Hg at 48 months postop (23% reduction). The mean number of glaucoma medications was 2.08 before surgery versus 1.46 at 48 months. Three eyes had IOP spikes of 15 mm Hg or higher post-surgery compared to the preop value. Twenty percent of eyes required secondary glaucoma surgery. Patients who previously used ocular hypotensive medications and who had an IOP of 18 mm Hg or higher had a statistically significant drop in both IOP and medication use. The study appears in the Journal of Cataract & Refractive Surgery.
  • Patients with systemic lupus erythematosus commonly use hydroxychloroquine, which can potentially lead to retina toxicity over time. Many of these patients have annual ophthalmic screenings after long-term use of the drug. In patients treated with hydroxychloroquine for more than 5 years, choroidal thinning and flow abnormalities seen via swept source OCT angiography in the retinal capillary plexuses and choriocapillaris may be observed even if best corrected visual acuity, fundus autofluorescence, multifocal electroretinography, automated visual field testing, and swept source OCT are normal, concluded Raimondo Forte and coresearchers. Their study included 10 patients (20 eyes) with a mean age of 38.91 years who were using hydroxychloroquine and 18 healthy controls (36 eyes, mean age: 38.87 years). The study is published in the American Journal of 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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