EW Weekly, April 26, 2019

Anti-integrin therapy for dry eye added to Allegro portfolio
ALG-1007, an anti-integrin therapy, has been added to the anti-integrin portfolio of Allegro Ophthalmics. ALG-1007 is a topical treatment designed to treat dry eye. The company’s current anti-integrin portfolio includes risuteganib (Luminate), under development for diabetic macular edema (DME) and dry age-related macular degeneration (AMD), according to a company press release.

FDA reviews investigational NDA for AR-13503 sustained-release implant
The U.S. FDA has reviewed the investigational New Drug Application (NDA) for AR-13503 (Aerie Pharmaceuticals), a multi-kinase inhibitor sustained-release implant, Aerie reported. This allows Aerie to initiate human studies to treat neovascular AMD and DME. The first-in-human clinical study is expected to begin in the second quarter of this year. The implant is designed to be administered about every 6 months via intravitreal injection.

U.S. clinical trials will begin for Technolas Teneo excimer laser
A series of U.S. trials will begin in July for the Technolas Teneo excimer laser (Bausch + Lomb) for vision correction surgery for myopia and myopic astigmatism. The system that will be studied is the same as the Technolas Teneo laser (model 2) sold now outside of the U.S. After the trials, the company plans to file for premarket approval of the laser.

First patient dosed in Phase 1 trial for IBI302 for wet AMD
The first patient has been dosed in a Phase 1 trial for IBI302 (Innovent Biologics), a recombinant fully human bispecific fusion protein targeting vascular endothelial growth factor and complement proteins to treat wet AMD, according to a company statement. The open-label, single-center, dose-escalation trial will provide a single intravitreal injection to patients to evaluate the safety and tolerability of IBI302.

Clinical program initiated for Quantum Dots for retinal degenerative diseases
The first-known clinical program to show the effectiveness and safety of Quantum Dots (2Ctech Inc.) to achieve photovoltaic stimulation of the neural retina to preserve or enhance vision in patients with retinal degenerative diseases, particularly retinitis pigmentosa, has begun, according to a company statement. Quantum Dots are semiconductor crystalline structures that absorb light and generate a dipole electrical field, in turn stimulating neuronal retina cells. The dots are a few nanometers wide. They are packaged in a single-use vial and delivered via a standard pars plana injection, according to the company. In preclinical and first-in-human trials, a one-time injection of Quantum Dots administered in the vitreous showed strong evidence of safety and indications of vision enhancement, the company reported. The next series of human studies are slated to meet the intent of the U.S. FDA’s Early Feasibility Study program requirements. The studies will take place at several sites throughout the U.S.

Generic tobramycin approved by FDA
The U.S. FDA has approved a generic tobramycin ophthalmic solution USP 0.3% made by Alembic Pharmaceuticals.

FDA approves generic loteprednol etabonate ophthalmic suspension 0.5%
The U.S. FDA has approved generic loteprednol etabonate ophthalmic suspension 0.5% made by Akorn.

Research briefs
  • When compared to standard IOLs or monovision, multifocal IOLs provide better uncorrected near vision and a higher proportion of patients who achieve spectacle independence, reported Sumitra Khandelwal and coresearchers in their systematic review of 25 randomized controlled trials of a multifocal IOL compared to a standard IOL or monovision and that reported spectacle independence, visual acuity, or quality of life. The studies were published between 2006 and 2017. In addition to other factors, there was borderline significantly better quality of vision for the multifocals. However, compared to monofocals, multifocals had statistically significantly worse pooled results for glare and halos. Newer multifocals had statistically significantly better outcomes than older diffractive lenses or refractive lenses in terms of near vision, quality of vision, and risk of halos. The review article is published in Graefe’s Archive for Clinical and Experimental Ophthalmology.
  • The use of angiotensin-converting enzyme inhibitor (ACE) inhibitors has sometimes been associated with a higher risk of cataract, but in a recently published large observational study, there was not a higher risk. Claudia Becker and coresearchers used data from the U.K.-based Clinical Practice Research Datalink and included first-time cataract patients age 40 or older between 1995 and 2015 and an equal number of cataract-free controls. The controls to cases were matched by age, sex, general practice, date of first cataract, and years of history in the datalink system. The number of prescriptions for ACE inhibitors and other antihypertensive drugs were assessed. There were 206,931 cataract cases and the same number of matched controls. The use of ACE inhibitors was not associated with a materially altered risk of cataract compared with non-ACE inhibitor use in the main analysis (OR 1.06, 95% CI 1.04 to 1.08) nor in any of the sensitivity or stratified analyses. The study is published in the British Journal of Ophthalmology.
  • In dry eye patients, true and sham acupuncture improved the Ocular Surface Disease Index (OSDI) at 1 week after treatment, but the results were more significant in the true treatment groups at 6 months, according to Deepinder Dhaliwal, MD, and coresearchers. Researchers in the prospective, randomized, double-blinded trial performed acupuncture per the Niemtzow Protocol, with 24 patients receiving true acupuncture and 25 receiving a sham treatment. Compared to baseline, OSDI scores in the treatment group improved compared to baseline, particularly by 6 months. Scores also improved in the sham group but did not reach significance. There was no significant improvement in secondary outcome measures, including tear breakup time, Schirmer’s test, ocular surface grading, or artificial tear application. However, there was a significant reduction in the frequency of eye closing at 3 months among patients in the true acupuncture treatment group. Intragroup analysis revealed a significant reduction in discomfort, dryness, scratchiness, and redness in the true treatment group at 3 months. The study is published in Clinical Ophthalmology.
  • Femtosecond laser-assisted cataract surgery (FLACS) lowered the risk of anterior capsule tears in white cataracts compared with patients receiving conventional phacoemulsification, reported Yanan Zhu, MD, and coresearchers. The prospective, consecutive, nonrandomized comparative cohort study divided patients into a FLACS group versus conventional phaco. Type I cataract was characterized as the presence of a liquefied cortex, but type II had a solid cortex. The study included 132 eyes of 132 patients, with 66 in each group. Anterior capsule tears occurred 12.1% of the time in the conventional phaco group versus none in the FLACS groups. All eight anterior capsule tears were type I cases. Six FLACS cases developed incomplete capsulotomies, four of which were type I. Posterior capsule rupture and vitreous loss were the same in both groups. The IOLs were better centered in the FLACS group. Mean ultrasound power, absolute phaco time, effective phaco time, and postop visual acuities were similar for both groups. The study is published in the Journal of Cataract & Refractive Surgery.

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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