EyeWorld Weekly Update, February 3, 2017

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February 3, 2017
Volume 22 , Number 5

Enrollment for Phase 3 trials for lampalizumab complete

Two Phase 3 clinical trials-Chroma and Spectri-for lampalizumab (Genentech, South San Francisco) have completed enrollment. Lampalizumab was developed to reduce the progression of geographic atrophy lesions secondary to age-related macular degeneration. "Lampalizumab is a monoclonal antibody fragment designed to inhibit complement factor D, a rate-limiting enzyme of the alternative complement pathway. This complement pathway is implicated in the development of age-related macular degeneration including GA," according to Genentech. The trials have enrolled 1,881 patients at about 300 study locations in more than 20 countries. The primary endpoint for both trials is the mean change in geographic atrophy lesion area at 1 year, comparing treatment to sham, with a planned overall treatment duration of 2 years.

Phase 2a study of emixustat hydrochloride initiates

The first patient was enrolled in late January in a Phase 2a study with the drug emixustat hydrochloride in subjects with macular atrophy secondary to Stargardt disease, according to a press release from Acucela (Seattle), a wholly-owned subsidiary of Kubota Pharmaceutical Holdings (Tokyo, Japan). "This multicenter, randomized, masked Phase 2a study is designed to evaluate the pharmacodynamics, safety and tolerability of emixustat," according to the release. Study investigators will enroll 30 subjects at four to six sites in the U.S. In a 1:1:1 ratio, subjects will be randomly assigned to one of three treatment arms that include emixustat 2.5 mg, emixustat 5 mg, and emixustat 10 mg. Subjects will take the drug orally once a day in the evening for a month.

FDA report analyzes results from Phase 2 and 3 trials that do not reach approval

A new report from the FDA focuses on 22 case studies for drugs, vaccines, and medical devices since 1999 in which positive Phase 2 trial results were not confirmed in Phase 3 testing. The analysis found that in 14 cases, Phase 3 results did not confirm Phase 2 results on effectiveness; one Phase 3 study did not confirm safety; and seven Phase 3 studies confirmed neither safety nor effectiveness. "These unexpected results could occur even when the Phase 2 study was relatively large and even when the Phase 2 trials assessed clinical trial outcomes," according to the report overview. "This paper is not intended to assess why each of these unexpected results occurred or why further product development was not pursued. Rather, these cases, chosen from a large pool of similar examples, illustrates the ways in which controlled trials of appropriate size and duration contribute to the scientific understanding of medical products," the FDA wrote.

Collaboration to focus on optogenetic therapy and visual deficits/blindness device

A new collaboration between Applied Genetic Technologies Corporation (AGTC, Gainesville, Florida) and Bionic Sight (Cambridge, Massachusetts) will focus on the development of new optogenetic therapy to leverage AGTC's experience in gene therapy and ophthalmology and Bionic Sight's neuroprosthetic device and algorithm for retinal coding. The companies plan to use optogenetics to stimulate remaining healthy cells in the retina and Bionic Sight's device to stimulate the cells with the retina's neural code to restore normal neural signaling in patients who are blind or have visual defects due to retinal disease. "Bionic Sight has demonstrated an ability to mimic normal image formation in preclinical studies, and we believe that is a potential to achieve an outcome for patients that greatly exceeds what is currently possible with prosthetic or gene therapy approaches in late-stage degenerative retinal diseases," said Sue Washer, AGTC president and CEO, in a press release.

RESEARCH BRIEFS

  • A retrospective 20-year review of clinical features, causative organisms, and visual acuity outcomes in eyes with acute-onset endophthalmitis after clear corneal cataract surgery found similar causative organisms and visual outcomes over the 2 decades. However, a number of isolates were resistant to cephalosporins and fluoroquinolones. Nicholas A. Yannuzzi, and colleagues, reviewed clinical and microbiology records for 63 eyes of 63 patients presenting to a tertiary referral center between October 2006 and 2015 with culture-positive endophthalmitis that took place up to 6 weeks after clear corneal cataract surgery. Coagulase-negative Staphylococcus was found in 39 (62%) of 63 eyes, and Staphylococcus aureus was found in 7 (11%) of 63 eyes; Streptococcus was isolated in 7 (11%) of 63 eyes. None of the gram-positive isolates were resistant to vancomycin. Twenty-four of 49 isolates (49%) were sensitive to cephalothin, cefazolin, and cefuroxime, according to researchers. "Sensitivity to fluoroquinolones included 22 of 52 (42%) to levofloxacin, 20 of 54 (37%) to ciprofloxacin, 16 of 47 (34%) to moxifloxacin, and 3 of 13 (23%) to gatifloxacin," the authors wrote. The study is published in the American Journal of Ophthalmology.
  • Female ophthalmologists filed fewer charges with Medicare compared with male ophthalmologists in 2012 and 2013, according to a review of reimbursements from the Centers for Medicare and Medicaid Services. Led by Ashvini K. Reddy, MD, and colleagues, the study included 16,111 ophthalmologists (19.1% female) in 2012 and 16,179 ophthalmologists (19.8% female) in 2013. The average female ophthalmologist collected a mean of $0.58 in 2012 for every dollar collected by the average male ophthalmologist. However, in 2013, mean and median collections were similar when comparing female versus male ophthalmologists. Researchers found that female ophthalmologists submitted fewer charges to Medicare. Even when data comparing men and women with similar clinical activity was examined, renumeration was still lower for females. "In both years, women were underrepresented among ophthalmologists with the highest collections," the researchers wrote. The study is published in JAMA Ophthalmology.
  • Clinicians should consider the use of patient-reported outcome measure questionnaires to facilitate surgical decision-making and outcome monitoring, according to Simon S.M. Fung, MA, FRCOphth, and colleagues, based on their study on this topic. The prospective cohort study recruited patients having cataract surgery between February and March 2013 at Moorfields Eye Hospital, London. Researchers used the Catquest-9SF, EuroQol 5-dimension questionnaire and visual analog scale, National Eye Institute Socialemotional Scale, and short-form Visual Function Index. The questionnaires were completed before surgery and at 3 weeks and 3 months postoperatively. Researchers found that correlations between patient-reported outcome questionnaires and visual acuity measures were "variable and weak at best," they reported. Visual acuity may not fully reflect patients' visual function, so questionnaires may provide a clearer picture of surgical outcomes, the researchers concluded. The study is published in the Journal of Cataract & Refractive Surgery.
  • The Asia Dry Eye Society has agreed to a definition of dry eye as follows: "Dry eye is a multifactorial disease characterized by unstable tear film causing a variety of symptoms and/or visual impairment, potentially accompanied by ocular surface damage." The group noted that this definition stresses tear film instability and the importance of visual impairment. There is a need for greater focus on dry eye as the disease becomes a greater part of daily life, wrote the researchers, led by Kazuo Tsubota, MD, PhD, and colleagues. Their publication in The Ocular Surface discusses the concept of Tear Film Oriented Therapy and how it evolved from the definition of dry eye. Their report also emphasizes the importance of a stable tear film.  

NEW PRODUCT BRIEFS

  • Alcon (Fort Worth, Texas) launched the AcrySof® IQ PanOptix® Toric lens, a trifocal toric astigmatism-correcting IOL, in Spain, Portugal, and Chile. The lens received a CE Mark status in November 2016 and is part of the PanOptix trifocal platform announced at the September 2015 European Society of Cataract and Refractive Surgeons meeting in Barcelona, Spain. Alcon is a division of Novartis (Basel, Switzerland).

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; Reay Brown, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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