EyeWorld Weekly Update, August 18, 2017

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August 18, 2017
Volume 23 , Number 28

Results announced from Phase 3 trial of pegpleranib for wet AMD

The primary endpoint of mean visual acuity change at 12 months was not met in a Phase 3 trial that compared the superiority of pegpleranib (Fovista, Ophthotech, New York) anti-PDGF therapy combined with aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York) or bevacizumab (Avastin, Genentech, South San Francisco) with aflibercept or bevacizumab monotherapy to treat wet age-related macular degeneration (AMD). In the international, multicenter, randomized Phase 3 study, subjects receiving pegpleranib in combination with aflibercept or bevacizumab gained a mean 9.42 letters of vision on the ETDRS standardized chart at 12 months compared with a mean gain of 9.04 letters in patients receiving monotherapy with aflibercept or bevacizumab. The resulting difference of 0.38 ETDRS letters was not statistically significant. The trial enrolled approximately 640 patients with wet AMD. Because of these results, Ophthotech decided to stop treating patients in the second year of the study, according to a company press release.

Orphan drug designation granted for gene therapy to treat X-linked retinitis pigmentosa

The U.S. Food and Drug Administration has granted an orphan drug designation for a gene therapy product candidate produced by Applied Genetic Technologies Corporation (Alachua, Florida) used to treat X-linked retinitis pigmentosa that is caused by mutations in the RPGR gene. The European Commission already granted orphan medicinal product designation for the same indication, according to a company press release. The company conducts human clinical trials of adeno-associated virus-based gene therapies that treat rare diseases. The orphan drug designation is granted to drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 individuals.

Marketing authorization sought in Europe for lifitegrast

A Marketing Authorization Application was submitted earlier this month for lifitegrast (Xiidra, Shire Pharmaceuticals, Lexington, Massachusetts). If approved, the agent would be the first and only treatment in the LFA-1 antagonist drug class to address dry eye signs and symptoms in adults in Europe.

Encourage safe viewing of Monday's solar eclipse

Eye practitioners are encouraging patients to safely view the solar eclipse that will take place for 2 to 3 hours on Monday. When sunlight burns and potentially scars the retina, solar retinopathy can occur, according to a news brief from the National Eye Institute (NEI). The NEI encourages consumers to view the solar eclipse through special-purpose solar filters. Pinhole projectors are another option.

RESEARCH BRIEFS

  • Home monitoring of visual field progression was helpful for glaucoma patients, even with a test compliance of 63%, according to Andrew Anderson, PhD, and researchers. Their computer simulation and cohort study included 43 patients with treated open-angle and closed-angle glaucoma and ocular hypertension or glaucoma suspects (mean age, 71 years). Researchers simulated a series of visual fields for patients with stable glaucoma and patients with progressive glaucoma for two in-clinic and three home-monitoring schedules over 5 years. "Although a sensitivity of 0.8 for rapid field loss was achieved after 2.5 years of 6-monthly testing in the clinic, weekly home monitoring achieved this by 0.9 years despite moderate test compliance of 63%," the authors wrote. The results showed that detecting rapid visual field progression may be improved with a home-monitoring strategy, but the cost benefit of this approach is not yet clear, they concluded. The research is published in Ophthalmology.
  • Boston type 1 keratoprosthesis (KPro) implantation in children has a higher complication rate, higher chance of device failure, and worse visual outcomes compared with adults, reported Simon S.M. Fung, FRCOphth, and co-researchers. Their retrospective multicenter case series focused on children under the age of 16 who had KPro surgery at three Canadian ophthalmology centers between January 2010 and November 2014. The KPro was used in 11 eyes of 11 patients. All patients had glaucoma; six patients had glaucoma drainage devices before KPro implantation. At the final follow-up (mean, 41.8 months), two eyes maintained a best corrected visual acuity of 20/400 or better, but five eyes lost light perception. That compared with a range of 20/125 to light perception before surgery, as well as a vision of fix and follow in two cases. Complications included retroprosthetic membrane (nine eyes), corneal melt (five eyes), infectious keratitis (three eyes), endophthalmitis (three eyes), glaucoma drainage device erosion (two eyes), and retinal detachment (five eyes). The authors do not recommend KPro use in a pediatric population. The study appears in Ophthalmology.
  • Swept-source optical coherence tomography (SS-OCT) can be used to help predict postop IOL tilt and help with toric IOL power calculations, both of which could potentially improve visual outcomes, according to Nino Hirnschall, MD, and co-researchers. The researchers compared crystalline lens tilt in eyes before and IOL tilt in eyes after cataract surgery with use of the IOLMaster 700 (Carl Zeiss Meditec, Jena, Germany). This prospective case series scanned eyes 1 week before and 2 months after cataract surgery. Sixty-two eyes (62 patients) were part of the study. Mirror symmetry between both eyes was found in the mean magnitude and direction of tilt between both eyes along the vertical axis and a primary nasal outward tilt for right and left eyes. There was a strong correlation between the preop mean direction of crystalline lens title and IOL tilt postoperatively. A weaker correlation was seen with the mean magnitude of tilt. The research is published in the Journal of Cataract & Refractive Surgery.
  • Cellular therapy of the human corneal stroma in vivo with autologous adipose-derived adult stem cells (ADASC) was safe in a Phase 1 study led by Jorge Alió del Barrio, MD. The study included five patients, and autologous ADASCs were obtained by elective liposuction. Patients were reviewed at 1 day, 1 week, and 1, 3, and 6 months postoperatively. Four patients finished the complete follow-up. There were no intraop or postop complications, and full corneal transparency recovery occurred within 24 hours. There was a mean 16.5-micron improvement as seen by corneal optical coherence tomography; new collagen production was seen as patchy hyperreflective areas at the stromal pocket level. Survival of the implanted stem cells at the surgical plane was observed. Future studies could help confirm these preliminary results, the authors concluded. The study appears in Cornea.

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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