EW Weekly, August 10, 2018

August 10, 2018
Volume 24 , Number 29

Tentative approval for bimatoprost ophthalmic solution

The U.S. Food and Drug Administration (FDA) has tentatively approved an abbreviated New Drug Application for bimatoprost ophthalmic solution 0.03% (Alembic Pharmaceuticals, Vadodara, India), according to a company press release. The agent is therapeutically equivalent to Latisse (Allergan, Dublin, Ireland) and is indicated to treat hypotrichosis of the eyelashes. The product launch is contingent on litigation between Alembic and Allergan; that litigation is underway in the District Court of New Jersey.

Phase 2 study of NCX 470 initiated for open angle glaucoma and ocular hypertension

A Phase 2 study has begun to evaluate NCX 470 (Nicox, Sophia Antipolis, France), a second-generation nitric oxide (NO)-donating prostaglandin analog to reduce IOP in patients with open angle glaucoma or ocular hypertension. The study has enrolled 10 patients so far. "NCX 470 is a new chemical entity which uses bimatoprost, a prostaglandin analog, as a scaffold for attaching an NO-donating moiety in order to achieve dual mechanism of action," according to a company press release. In preclinical models, NCX 470 demonstrated a 2 to 3 mm Hg greater IOP reduction than bimatoprost alone. The Phase 2 research is a multicenter, 28-day, parallel-group, dose-ranging study that aims to evaluate the efficacy and safety of NCX 470 compared to latanoprost 0.005%. A total of 420 patients across the U.S. are expected to be part of the trial. The primary study endpoint will be the mean reduction in diurnal IOP after 4 weeks of treatment. Top-line data from the study are expected in the second half of 2019.

Results announced from Phase 1/2 trial for retinal scarring treatment

Results from a Phase 1/2 trial for RXI-109 (RXi Pharmaceuticals, Marlborough, Massachusetts) were announced earlier this month. RXI-109 is a self-delivering RNAi compound that targets connective tissue growth factor. The RXI-109-1501 trial was an open-label, multidose, dose-escalation study with three dose cohorts enrolled sequentially. The study evaluated the safety and tolerability of RXI-109 injections in the eyes of subjects with advanced neovascular age-related macular degeneration and subretinal fibrosis. The clinical effect of the injections was a second endpoint. "The primary objective was met as shown by the absence of dose-limiting and serious toxicities, and only mild to moderate procedure-related adverse events," according to a company press release. However, none of the adverse events were drug related. No indications of inflammation or other tolerability issues were seen. The study also met secondary objections with improved or stable disease in study eyes, according to the press release.

First U.S. study of device for blind retinitis pigmentosa patients initiated

An early feasibility study to implant the Alpha AMS subretinal device (Retina Implant, Reutlingen, Germany) in patients blind due to retinitis pigmentosa has been approved by the FDA. The study will take place at Wills Eye Hospital, Philadelphia. The device was designed to replace the nonfunctioning and absent photoreceptor cells in the eye lost to retinitis pigmentosa deterioration, according to a Wills press release. The surgically implanted device stimulates the remaining visual system components to restore limited functional vision in blind retinitis pigmentosa patients. Up to eight patients will be enrolled for device implantation. The Alpha AMS is an investigational device in the U.S. but has had the CE mark approval in Europe since 2016.

2018 ASCRS Ophthalmology Hall of Fame: Nominate a candidate today

Nominations are being accepted for the 2019 ASCRS Ophthalmology Hall of Fame. Do you know someone who has made a significant contribution to ophthalmology? Nominate them before the October 1 deadline. Eligible candidates are those with 25 or more years of scholarly achievement and at least one solid, defining contribution to ophthalmology in clinical practice, research, education, invention, or humanitarian work. Chosen inductees will be recognized at the 2019 ASCRS/ASOA Annual Meeting, being held May 3-7, 2019 in San Diego. An induction ceremony will be held during the ASCRS Opening General Session on Saturday, May 4. You can view the 2018 Hall of Fame video honoring I. Howard Fine, MD, and David Maurice, MD, online. The ASCRS Ophthalmology Hall of Fame was created by ASCRS in 1999 to honor the pioneers of ophthalmology. In the past 19 years, 61 outstanding ophthalmologists have been chosen for induction, by their peers.


  • Increased near visual activity and reduced time outdoors may contribute to incident myopia in children, according to a population-based study in Taiwanese children, reported Po-Wen Ku, PhD, and coauthors. A total of 1,958 children from age 7 to 12 from the Taiwan 2009 National Health Interview Survey were included. The children who were included had claims data from 2009 to 2013 in the National Health Insurance system. Multivariate Cox proportional hazard models were used to estimate the association between incident myopia and three near visual activities: reading, use of the computer/internet/video games, and "cram school" attendance. Prevalent myopia was defined as those with two or more ambulatory care claims in 2008 to 2009, while incident myopia was defined by those who had at least two ambulatory care claims during the 4-year follow-up. A total of 26.8% of children had myopia at baseline; 27.7% of those without myopia at baseline developed incident myopia between 2010 and 2013. Among the three near visual activities, the largest portion of time was spent on cram school. Children attending cram schools for 2 or more hours a day had a higher risk of incident myopia. The study appears in Ophthalmology.
  • Idiopathic and nonadherent subgroups of patients having resident-performed cataract surgery were successfully treated with topical anti-inflammatory therapy. However, a complicated subgroup required a longer treatment duration and multiple treatment modalities, reported Saagar Patel, BA, and coresearchers. Their retrospective case series focused on risk factors, therapeutic interventions, intraop and postop complications, and visual outcomes for persistent postop inflammation in primary resident-performed cataract surgeries from January 2012 to June 2015. Persistent postop inflammation was defined as persistent anterior chamber inflammatory reaction after a standard 1-month topical corticosteroid and nonsteroidal anti-inflammatory drug drops taper. A total of 1,290 surgeries were analyzed. Persistent inflammation occurred in 82 (6.6%) eyes. The presumed etiology was idiopathic persistent postop inflammation, nonadherence to topical therapy, and complicated cataract surgery. Those with persistent inflammation were more likely to be of African American descent, had hypertension, or used aspirin, anticoagulants, or prostaglandins. The subgroup of complicated patients required a longer duration of therapy and was the only subgroup requiring injections or systemic corticosteroids. There was no significant difference among the groups for postop corrected distance visual acuity. The research appears in the Journal of Cataract & Refractive Surgery.
  • After 1 year of follow-up in a study comparing use of the primary Baerveldt glaucoma implant (Johnson & Johnson Vision, Santa Ana, California) versus trabeculectomy, trabeculectomy showed better results than the Baerveldt implant, reported Esma Islamaj and coresearchers. Their randomized, comparative study included 119 glaucoma patients without previous ocular surgery. One eye of each subject was randomized for the Baerveldt device or trabeculectomy. Follow-ups were done at 1 day, 2 and 6 weeks, 3 and 6 months, and at 1 year. The final IOP was equivalent for both treatment groups: 14 mm Hg for the Baerveldt group and 13 mm Hg for the trabeculectomy group. There was no significant difference in the failure rate between the two groups. The Baerveldt group needed more medication to decrease their IOP. The self-limited complication rate was similar in both groups; diplopia was significantly more common in the Baerveldt group. The study is published in Acta Ophthalmologica.

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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