EyeWorld Weekly Update, December 15, 2017

December 15, 2017
Volume 23 , Number 43

FDA accepts supplemental Biologics License Application for 12-week dosing of aflibercept

The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for 12-week dosing of aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York) for wet age-related macular degeneration (AMD). The goal for review of a Biologics License Application is 10 months from submission, which would make the target action date Aug. 11, 2018, according to a Regeneron press release. The application is based on analysis of 2-year results from the VIEW 1 and VIEW 2 Phase 3 trials; an integrated analysis found that 51% of study patients had their aflibercept dosing extended to every 12 weeks when they began their second year of treatment. They maintained the 12-week dosing schedule and kept their best corrected visual acuity gains. Patients following the 12-week dosing schedule had no evidence of new or progressive wet AMD at the end of the second year of treatment.

Use of phenylephrine/ketorolac approved in pediatric patients

The U.S. FDA approved a supplemental New Drug Application for phenylephrine/ketorolac intraocular solution (Omidria, Omeros, Seattle) in pediatric patients. The agent is already approved in adults. Omidria is used during cataract surgery or IOL replacement. It helps prevent intraoperative miosis and lowers postoperative pain. Data to support the use of phenylephrine/ketorolac intraocular solution in children comes from a clinical trial with 78 pediatric patients randomized to receive Omidria or phenylephrine only administered intraoperatively. The FDA also gave phenylephrine/ketorolac 6-month extension of market exclusivity, according to an Omeros press release.

First patient dosed in Phase 2 trial for allergic conjunctivitis agent

The first patient has been dosed in a Phase 2 trial for PR013 (Realm Therapeutics, Malvern, Pennsylvania), an agent for allergic conjunctivitis, according to a company press release. PR013 is the company's topical ophthalmic formulation of a high concentration hypochlorous acid. The multicenter, double-blind, randomized evaluation of the effectiveness of PR013 compares the agent to vehicle to treat allergic conjunctivitis using a modified Conjunctival Allergen Challenge Model in about 90 patients. Top-line data from the study are expected to be ready in the second quarter of 2018.

Six new patents issued in Europe, U.S. to cover SF0166 for retinal diseases

The European Patent Office has issued a patent for SF0166 (SciFluor Life Sciences, Cambridge, Massachusetts), a selective small molecule inhibitor of integrin ανβ3 for diabetic macular edema and wet AMD. The European patent is supported by five additional patents issued recently by the U.S. Patent and Trademark Office, according to a company press release. The patents provide intellectual property protection for SF0166 and its analogs for composition of matter and methods of use through the year 2034, SciFluor reported. The agent is under development and administered as an eye drop. "Topline results from the Phase 1/2 study of SF0166 in DME announced earlier this year demonstrated the safety in this indication as well as the encouraging signs of biological activity," said Scott Edwards, SciFluor Life vice president and general manager, in a press release.


  • The solar eclipse earlier this year led to the case of a young adult woman who presented 3 days later with classic symptoms of solar retinopathy, reported Chris Wu, MD, and fellow authors. Spectral-domain OCT images were consistent with mild and severe acute solar retinopathy. The patient's microperimetry was normal in the right eye, but there was paracentral decreased retinal sensitivity in the left eye, with a central absolute scotoma. A small region of non-waveguiding photoreceptors was seen via adaptive optics images of the right eye. A small circular hyperreflective area with central hyporeflectivity in the outer retina was seen via en face OCT images. Young adults may be particularly vulnerable to solar retinopathy and should be better informed of related risks associated without the use of protective eyewear, the researchers concluded. The case report appears in JAMA Ophthalmology.
  • Visual acuity does not improve with the use of intravitreal dexamethasone without preservatives as an adjuvant to intravitreal antibiotics in patients who have been treated for suspected bacterial endophthalmitis after cataract surgery, according to Sonia Manning and fellow researchers. Their randomized, placebo-controlled superiority trial in three tertiary referral centers included 167 patients with suspected bacterial endophthalmitis within 6 weeks after cataract surgery. A vitreous biopsy was taken for culture; patients received intravitreal injections of 400 micrograms of non-preserved dexamethasone or placebo as well as 0.2 mg vancomycin and 0.05 mg of gentamicin. Over the 10-year period during which patients presented, 81 received dexamethasone, and 86 were in the placebo group. Sixty-eight percent of biopsies were culture-positive. The final biopsy did not differ when comparing the dexamethasone and placebo group. The research is published in Acta Ophthalmologica.
  • Younger ophthalmologists were more likely to receive an unsolicited patient complaint, according to the results of a cohort study of 1,342 ophthalmologists. Led by Cherie Fathy, MD, the ophthalmologists in the study were separated into five age bands and followed up from the time of their employment to the receipt of their first complaint. All ophthalmologists who were included had graduated from medical school before 2010. Ophthalmologists age 70 and older had the lowest number of complaints (0.71 per 1,000 follow-up days compared with 1.41, 1.84, 2.02, and 1.88 in descending age band order). "The two youngest age bands were associated with a statistically significant shorter time to first complaint," according to the researchers. The results may have practical implications for patient safety, clinical education, and clinical practice management, the researchers concluded. The study appears in JAMA Ophthalmology.
  • A younger patient age and poor glycemic control were risk factors for a postoperative central retinal thickness increase in a prospective case series led by Petteri Ylinen, MD. Their study included 93 patients (95 eyes) with type 1 or type 2 diabetes who were having routine cataract surgery. Spectral-domain OCT imaging was performed before surgery and at 1 month postop. There was an average central retinal thickness increase of 9.7 microns in patients with diabetes but no retinopathy compared with 22.7 microns in those with non-proliferative retinopathy and 73.8 microns in those with proliferative retinopathy (P<.001). Patients with diabetes who used insulin had a greater central retinal thickness increase compared with those who did not use insulin. Hemoglobin A1c and inversely, patient age were associated with a central retinal thickness increase, even after adjusting for other confounding factors. There was a smaller central retinal thickness change in patients who used a nonsteroidal anti-inflammatory drug (NSAID) as their postop medication than in the eyes of patients who were not prescribed an NSAID when retinopathy was assessed as a covariant, the researchers reported. It is important to identify, treat, and follow up with patients who have diabetes and are subsequently at a greater risk for cystoid macular edema, the researchers concluded. The study appears in the Journal of Cataract & 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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