EyeWorld Weekly Update, May 19, 2017

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May 19, 2017
Volume 22 , Number 19

Initial FDA review of Rhopressa NDA is complete; target date set for complete review

The U.S. Food and Drug Administration (FDA) has completed its initial 60-day review of the New Drug Application (NDA) for Rhopressa (netarsudil ophthalmic solution 0.02%, Aerie Pharmaceuticals, Irvine, California), according to an Aerie press release. The Prescription Drug User Fee Act goal for completion of the FDA's review of the Rhopressa NDA is set for Feb. 28, 2018. The FDA has not identified any potential review issues with the agent's NDA, according to Aerie. Rhopressa targets the trabecular meshwork, and in clinical studies, it has been shown to lower episcleral venous pressure. It is a once-daily product.

ADX-102 comparable to topical ocular corticosteroids in Phase 2 study

In a Phase 2 clinical trial of topical ocular ADX-102 (Aldeyra Therapeutics, Lexington, Massachusetts), ADX-102 activity was comparable to standard-of-care topical ocular corticosteroids in reducing the anterior chamber cell count in patients who had active noninfectious anterior uveitis. Additionally, ADX-102 did not raise IOP. In the study, 45 subjects were randomized equally to receive ADX-102 0.5% four times a day, Pred Forte (prednisolone acetate ophthalmic suspension, Allergan, Dublin, Ireland) four times a day (tapered), or ADX-102 0.5% and Pred Forte twice daily. The groups did not have any significant differences in clinical endpoints, including anterior chamber cell count and ocular flare. After 4 weeks of therapy, 53% of patients treated with ADX-102 achieved anterior chamber cell count grade of 0 versus 38% for patients treated with corticosteroids. Twenty percent of patients receiving ADX-102 needed rescue medication compared with 38% of patients receiving corticosteroids. The mean IOP increased in the corticosteroid group but dropped slightly in the ADX-102 group. Aldeyra is initiating a Phase 3 clinical trial of topical ADX-102 for noninfectious anterior uveitis and expects to enroll up to 100 patients with active disease. Trial results are expected in the second half of 2018.

FDA: Fluoroquinolones not associated with retinal detachment

The use of fluoroquinolone antibiotics does not appear to be associated with retinal detachment or aortic aneurysm and aortic dissection, according to the FDA. Their drug safety communication from earlier this month was an update to a May 2016 report that advised restricting fluoroquinolone antibiotic use to "certain uncomplicated infections." The 2016 report also warned of what it called disabling side effects, including unusual joint or tendon pain, muscle weakness, a "pins and needles" tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. The FDA will continue to analyze safety issues with fluoroquinolones, according to this month's communication.

Primary eye exams fail to detect AMD in 25% of patients

In a dilated eye exam by primary care eye physicians, 25% that were designated as normal actually had macular characteristics indicative of age-related macular degeneration (AMD) by fundus photography and trained raters, according to David Neely, MD, and co-investigators. Their cross-sectional study focused on 644 people over the age of 60 who had normal macular health per their medical record and their most recent dilated comprehensive eye exam. Researchers used the Clinical Age-Related Maculopathy Staging System to check for the presence of AMD and a masked grader. Of 1,299 eyes from the 644 participants, 75.2% had no AMD; 24.8% had AMD despite no diagnosis of it in the medical record. In the eyes with AMD, 10% had hyperpigmentation, 13.4% had hypopigmentation, 77.8% had small drusen, 78.1% had intermediate drusen, and 30% had large drusen. Factors associated with undiagnosed AMD included an older patient age, male sex, and less than a high school education. "Improved AMD detection strategies may be needed in primary eye care as more effective treatment strategies for early AMD become available in the coming years," the investigators wrote. The study appears in JAMA Ophthalmology.

RESEARCH BRIEFS

  • Intravitreal bevacizumab (Avastin, Genentech, South San Francisco) and aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York) had a similar mean visual acuity letter score increase from baseline in patients with macular edema due to central retinal vein occlusion (CRVO). Led by Ingrid Scott, MD, and the SCORE2 Investigator Group, 362 patients were studied. Although aflibercept has established safety and efficacy to treat macular edema due to CRVO, bevacizumab is used off-label. The randomized clinical trial took place at 66 private practice or academic centers around the U.S. Patients were randomized 1:1 to receive aflibercept or bevacizumab every 4 weeks through 6 months. The primary outcome was a mean change in visual acuity letter score from the randomization visit to the 6-month follow-up visit, according to investigators. At 6 months, the mean visual acuity letter score was 69.3 in the bevacizumab group and 69.3 in the aflibercept group. The mean increase from baseline was 18.6 and 18.9, respectively. The results met the criteria for non-inferiority. Ocular adverse events for the aflibercept group included four patients with IOP more than 10 mm Hg greater than baseline; in the bevacizumab group, there was one patient with culture-negative endophthalmitis, nine with an IOP of more than 10 mm Hg greater than baseline, two with an IOP greater than 35 mm Hg, and one patient with angle closure glaucoma but that was not attributed to the study drug or procedure. The study is published in JAMA.
  • Remodeling patterns after femtosecond LASIK and small incision lenticule extraction (SMILE, Carl Zeiss Meditec, Jena, Germany) differ on topography, according to Ik-Hee Ryu, MD, and fellow investigators. Their study compared topographic epithelial thickness changes in 175 eyes with myopia having femtosecond LASIK (62 eyes) or SMILE (113 eyes). The epithelial thickness was evaluated before surgery and at 1 and 3 months postoperatively. Topographic epithelial thickness and thickness variability were compared between the two groups. Epithelial thickness did not change between 1 and 3 months after surgery in the SMILE group, but it did increase after femtosecond LASIK. At 3 months after LASIK, a larger increase of epithelial thickness was observed in the central zone compared with SMILE. Topographic thickness variability also was larger after LASIK. Corneal epithelial thickness was proportional to the amount of myopia correction, the investigators wrote. The study is published in the Journal of Refractive Surgery.
  • Optical coherence tomography (OCT) imaging should be considered as an adjunct to a routine dilated fundus exam for macular evaluation, especially when premium IOLs may be used, according to Sidra Zafar, MB BS, and co-investigators. Their conclusion comes from a study focused on the incremental benefit of swept-source OCT to identify occult macular disease in patients slated for routine cataract surgery. The study included scans from 155 patients who were scheduled to have cataract surgery. Investigators found macular pathology in 10.9% of patients. The most commonly identified conditions were AMD, idiopathic epiretinal membrane, and vitreomacular interface abnormalities. However, investigators also found cystoid macular edema and ellipsoid zone abnormalities. The study appears in the Journal of Cataract & Refractive Surgery.

NEW PRODUCT BRIEFS

  • The Precizion Presbyopic IOL with continuous transitional focus design (Ophtec, Groningen, the Netherlands) received the CE mark. It will launch commercially in October at the ESCRS Congress in Lisbon, Portugal and be initially available in the European Union and a few select markets.

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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