EW Weekly, February 22, 2019

February 22, 2019
Volume 24 , Number 7

First gene therapy procedure performed for AMD

The first gene therapy procedure was performed this month for AMD at John Radcliffe Hospital, Oxford, England. The procedure was performed by Prof. Robert MacLaren, professor of ophthalmology, University of Oxford, with support from the NIHR Oxford Biomedical Research Centre in a clinical trial by Gyroscope Therapeutics, according to a press release. The operation was part of the FOCUS trial and involved detachment of the retina and injecting a virus with a modified DNA sequence to correct the genetic defect that causes AMD. If successful, such a procedure would need to be performed only once. "The idea of this gene therapy is to 'deactivate' the complement system, but at a very specific point at the back of the eye, so the patient would otherwise be unaffected by it, and we hope that in [the] future it will slow down the progression of macular degeneration," Prof. MacLaren said in the press release.

Broader patient population announced for Phase 3 MicroProst program

A broader patient population has been announced for the Phase 3 MicroProst program (microdose latanoprost with Optejet delivery, Eyenovia). After discussions with the U.S. FDA, the study population now will include chronic angle closure glaucoma in addition to open angle glaucoma and ocular hypertension patients. The Phase 3 program will be optimized to consist of a single MicroProst Phase 3 trial and supplemented with existing data on latanoprost for IOP lowering, according to an Eyenovia press release.

FDA accepted NDA for triamcinolone injection for macula edema with uveitis

The FDA has accepted the New Drug Application (NDA) for XIPERE (triamcinolone acetonide ophthalmic suspension, Clearside Biomedical) for suprachoroidal injection to treat macular edema associated with uveitis. The Prescription Drug User Fee Act goal date has been assigned for Oct. 19 of this year, according to a Clearside press release. The NDA filing is supported by data from the company's PEACHTREE Phase 3 clinical trial, which enrolled 160 patients with macular edema associated with noninfectious uveitis and compared XIPERE dosed every 12 weeks to sham control. Forty-seven percent of patients in the treatment arm gained at least 15 letters in best corrected visual acuity (BCVA) from baseline at week 24 compared with 16% in the control arm.

Orphan Drug Designation given to treatment for ocular melanoma

The FDA gave Orphan Drug Designation status to the small molecule oncolytic immunotherapy PV-10 (Provectus) for ocular melanoma, according to a Provectus press release. The Orphan Drug Designation was granted previously to PV-10 to treat metastatic melanoma, hepatocellular carcinoma, and neuroblastoma.

Bausch Health acquires EM-100, investigational eye drop for ocular itching due to allergies

Bausch Health has acquired U.S. rights to EM-100, an investigational eye drop from Eton Pharmaceuticals that, if approved, will be the first over-the-counter preservative-free formulation eye drop to treat ocular itching associated with allergic conjunctivitis, according to Bausch Health. EM-100 has been submitted to the FDA for review.

IRIDEX, Quantel Medical resolve infringement dispute

IRIDEX and Quantel Medical have resolved an earlier dispute that claimed that Quantel infringed IRIDEX's MicroPulse U.S. Trademark. IRIDEX dismissed the lawsuit it filed earlier.

Research briefs

  • Cataract surgery does not seem to slow the rate of glaucoma-related visual field decay compared with rates measured during cataract progression, concluded Ji Hyun Kim and coauthors. They focused on the hypothesis that cataract surgery slows the apparent rate of visual field decay in primary open angle glaucoma patients. The study included consecutive open angle glaucoma patients who had cataract surgery and who had 4 or more visual fields and 3 or fewer years of follow-up before and after surgery. A total of 134 eyes of 99 patients were included. The mean follow-up was 6.5 and 5.3 years before and after cataract surgery. All IOP parameters, including mean IOP, SD of IOP, and peak IOP, significantly improved after cataract surgery. All visual field indices indicated an accelerated visual field decay rate after cataract surgery. A worse baseline mean deviation and postoperative peak IOP were significantly associated with the postop visual field decay rate and the change in decay rate after cataract surgery. The study appears in the American Journal of Ophthalmology .
  • In a registry study of patients with keratoconus, the BCVA in the better eye had the strongest correlation with reading and mobility scores, while the BCVA in the worst eye correlated significantly with emotional scores, according to JCK Tan and coresearchers. They used the Impact of Vision Impairment Questionnaire with patients who have keratoconus and who were enrolled in the Save Sight Keratoconus Registry. Among the 107 patients who were included, 34.5%, 38%, and 26.9% had mild, moderate, and severe keratoconus, respectively. The K2 and Kmax in the better eye also had significant associations with reading and mobility scores. The study is published in Cornea .
  • In a prospective, cost-effectiveness analysis, bilateral toric IOL implantation in cataract patients with corneal astigmatism was not cost effective compared with monofocal implantation, reported Rob Simons and coresearchers. Their study focused on patients from two ophthalmology clinics in the Netherlands. Researchers used resource-use data from a 6-month postop period and included consecutive patients with bilateral age-related cataract and 1.25 D or more of corneal astigmatism. Patients were randomized to receive phacoemulsification with bilateral or monofocal IOLs. A total of 77 consecutive patients were analyzed. Societal costs were higher in the toric IOL group ($3,864) compared with the monofocal IOL group ($3,373). The quality-adjusted life years were slightly lower in the toric IOL group. The research appears in the Journal of Cataract & Refractive Surgery .
  • Topography-guided myopic astigmatism LASIK that was treated on the topography-measured anterior corneal astigmatism axis resulted in inferior refractive and visual outcomes compared with treatment on the clinical manifest refractive astigmatism axis, reported Avi Wallerstein, MD, and coresearchers. The researchers focused on whether topography-guided LASIK with anterior corneal astigmatism measured on the WaveLight Contoura (Alcon) would lead to better refractive outcomes. The retrospective analysis included 1,274 consecutive LASIK eyes. In eyes with a small axis discrepancy of 5 to 20 degrees between anterior corneal astigmatism and refractive astigmatism, both treatments achieved 20/20 uncorrected distance visual acuity (UDVA) in 90% of eyes. Ninety-five percent had a postoperative cylinder of 0.50 D or less. In eyes with a large axis discrepancy between 21 and 45 degrees treated on the anterior corneal astigmatism axis, the outcomes were statistically and clinically inferior. Fewer eyes achieved a UDVA of 20/20, and fewer had a defocus equivalent of 0.25 and 0.75 D or less. The study is published in the Journal of Refractive Surgery .

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, 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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