EW Weekly, May 17, 2019

FDA approves EYLEA injection for diabetic retinopathy
The U.S. FDA has approved anti-vascular endothelial growth factor EYLEA (aflibercept, Regeneron Pharmaceuticals) to treat all stages of diabetic retinopathy. The approval was based on data from the PANORAMA trial, which showed how EYLEA reduced the risk of proliferative diabetic eye disease when administered via a 16-week or 8-week dosing regimen. First patient enrolled in Phase 3 trial for dry eye treatment The first patient has been enrolled in ARISE-3, a Phase 3 clinical trial sponsored by ReGenTree LLC, a joint venture between RegeneRx and GtreeBNT, according to a RegeneRx press release. The trial will evaluate and compare RGN-259, a sterile, preservative-free eye drop, in 700 dry eye patients against placebo. The study will take place at an estimated 15 nationwide clinical sites across the U.S. The trial should be completed in mid-2020, according to the company. RGN-259 eye drops contain thymosin beta 4, a naturally occurring protein in tears and other body fluids. In ARISE-1 and ARISE-2, patients experienced only minimal ocular discomfort similar to that of placebo, the company reported. Results announced from ex-U.S. proof-of-concept trial with ALG-1007 for dry eye At its highest dose concentration (0.6%), the new investigational topical drug ALG-1007 (Allegro Ophthalmics) had statistically significant efficacy in nearly all assessments for dry eye and a more rapid onset of action compared to the lowest dose (0.125%), according to a company press release. The results were part of an ex-U.S. proof-of-concept trial. The trial concluded that ALG-1007 demonstrated a dose response, indicating that the active pharmaceutical ingredient is effective at improving signs and symptoms of dry eye at as early as 2 weeks. ALG-1007 also was well tolerated, with no drug-related adverse events. The trial included 40 eyes of 21 patients diagnosed with dry eye for at least 6 months. Patients were assigned to one of four doses, 0.125%, 0.25%, 0.4%, and 0.6%, in a lubricating ophthalmic topical solution. Subjects were assessed at various timepoints for 12 weeks. 6-month data reported from Phase 1/2 trial of AAV-RPE65 for RPE65-deficiency The primary endpoint of safety and tolerability were met in a Phase 1/2 dose escalation trial of AAV-RPE65 (MeiraGTx Holdings) used to treat RPE65-deficiency, which can cause blindness. AAV-RPE65 also showed statistically significant improvement across various secondary endpoints.

First patient enrolled in Phase 3 trial for dry eye treatment
The first patient has been enrolled in ARISE-3, a Phase 3 clinical trial sponsored by ReGenTree LLC, a joint venture between RegeneRx and GtreeBNT, according to a RegeneRx press release. The trial will evaluate and compare RGN-259, a sterile, preservative-free eye drop, in 700 dry eye patients against placebo. The study will take place at an estimated 15 nationwide clinical sites across the U.S. The trial should be completed in mid-2020, according to the company. RGN-259 eye drops contain thymosin beta 4, a naturally occurring protein in tears and other body fluids. In ARISE-1 and ARISE-2, patients experienced only minimal ocular discomfort similar to that of placebo, the company reported.

Results announced from ex-U.S. proof-of-concept trial with ALG-1007 for dry eye
At its highest dose concentration (0.6%), the new investigational topical drug ALG-1007 (Allegro Ophthalmics) had statistically significant efficacy in nearly all assessments for dry eye and a more rapid onset of action compared to the lowest dose (0.125%), according to a company press release. The results were part of an ex-U.S. proof-of-concept trial. The trial concluded that ALG-1007 demonstrated a dose response, indicating that the active pharmaceutical ingredient is effective at improving signs and symptoms of dry eye at as early as 2 weeks. ALG-1007 also was well tolerated, with no drug-related adverse events. The trial included 40 eyes of 21 patients diagnosed with dry eye for at least 6 months. Patients were assigned to one of four doses, 0.125%, 0.25%, 0.4%, and 0.6%, in a lubricating ophthalmic topical solution. Subjects were assessed at various timepoints for 12 weeks.

6-month data reported from Phase 1/2 trial of AAV-RPE65 for RPE65-deficiency
The primary endpoint of safety and tolerability were met in a Phase 1/2 dose escalation trial of AAV-RPE65 (MeiraGTx Holdings) used to treat RPE65-deficiency, which can cause blindness. AAV-RPE65 also showed statistically significant improvement across various secondary endpoints.

New eye/brain center opens in collaboration with Wills Eye
In partnership with Wills Eye Hospital, Philadelphia, Thomas Jefferson University has opened the William H. Annesley, Jr., MD ’48 EyeBrain Center, which will focus on visual manifestations of neurological diseases. The center’s clinicians and researchers will explore connections between the retina, optic nerve, and disorders of the brain including stroke, Alzheimer’s, Parkinson’s disease, multiple sclerosis, and dementia, according to a press release.

Allergan awarded $48.5K at trial over Imprimis false ads
A federal jury awarded Allergan $48,500 following a trial in which it claimed Imprimis Pharmaceuticals engaged in misleading advertising concerning FDA approval of its compounded drugs. The complaint was filed under the Lanham Act, a federal law that prohibits false advertising.

Register now for “Great Surgery Begins with Great Communication: Managing Communications and Expectations with Our Patients” webinar
Register now and join ASCRS experts Vance Thompson, MD, Richard Tipperman, MD, and Elizabeth Yeu, MD, on June 5 at 9:00 p.m. EDT for the webinar “Great Surgery Begins with Great Communication: Managing Communications and Expectations with our Patients.” Experts will present real case scenarios when discussing with patients the different options of refractive cataract surgery including pre-experience education and chair time discussions, communicating and setting appropriate patient expectations, and managing the unhappy patient. This live webinar has been approved for AMA PRA Category 1 Credit . If you are unable to join the live event, the webinar will be captured and available on the Center for Learning at ascrs.org afterward.

Research briefs
  • High-output ophthalmology clinics may lead to better patient outcomes, particularly in developing nations, reported Jacob Cox, MD, and coresearchers in their study assessing associations between annual surgeon case volume and visual acuity after cataract surgery. The study included all adult eyes that had small incision cataract surgery or phacoemulsification with IOL replacement at Aravind Eye Hospital, Madurai, India, in 2015. The main outcome measure was the postop uncorrected visual acuity (UCVA) after cataract surgery. A total of 35,880 eyes were included in the study, and surgeries were performed by 69 surgeons who varied in annual case volume from 76 to 2,900 cases during the study period. Increasing annual surgeon case volume was independently associated with a statistically significant but clinically modest improvement in UCVA in phaco cataract extraction but not in small incision cataract surgery. The association was more pronounced when comparing surgeons with case volumes of 350 phaco cataract extractions a year or fewer. Surgeons who had a higher volume than this had similar results. Increased annual case volume also was associated with significantly lower complication rates. The concept of high-output ophthalmology clinics can benefit developing nations where there is a large backlog of untreated cataracts and the cataract-to-surgeon ratio is high, the researchers concluded. The study is published in Ophthalmology.
  • Use of femtosecond laser-assisted cataract surgery (FLACS) in eyes with shallow chambers led to clearer corneas, less of an increase in central corneal thickness, lower anterior chamber inflammation, and better uncorrected distance visual acuity in the early postop period compared with conventional phaco, reported Viraj Vasavada, MD, and coresearchers. Their prospective, randomized, masked clinical study included patients with an anterior chamber of 2.5 mm or less who were randomized to have FLACS (n=91) or conventional phaco (n=91). Cumulative dissipative energy was lower in the FLACS group (P<.05). The mean central corneal thickness was significantly lower in the FLACS group at 1 day and 1 week, and there were fewer eyes with grade 2 anterior chamber cells and flare with FLACS at 1 day and 1 week. The uncorrected distance visual acuity was better with FLACS at 1 week. Although the reduction in endothelial cell density was lower in the FLACS group at 6 months, it was not a statistically significant difference. The research appears in the Journal of Cataract & Refractive Surgery.
  • High serum cholesterol levels were associated with a higher risk of primary open angle glaucoma (POAG) in adults age 40 or older, according to Jae Kang, ScD, and fellow researchers. However, use of statins appeared to lower the risk for POAG. Their population-based cohort study included participants from the Nurses’ Health Study, the Nurses’ Health Study 2, and the Health Professionals Follow-up Study in which information on elevated cholesterol status, serum cholesterol levels, and statin use were self-reported every other year. Among the 136,782 participants in the three cohorts, there were 886 incidence cases of POAG. Every 20 mg/dL increase in total serum cholesterol was associated with a 7% increase in POAG risk. A history of any statin use was associated with a 15% lower risk of POAG, but a history of statin use for 5 years or more was associated with a 21% lower risk. The study is published in JAMA Ophthalmology.
  • A survey of American Glaucoma Society members found that they would prefer for themselves microinvasive glaucoma surgery over traditional trabeculectomy or a glaucoma drainage device, reported Ta Chang, and coresearchers. The survey asked participants to adopt the role of a patient with POAG with progressive visual field loss and a need for glaucoma surgery at various IOP points. Among the 289 responses, the largest preferences were an ab interno trabeculotomy (20.3%), a XEN Gel Stent (Allergan) (18.6%), an iStent (Glaukos) with two devices (14.3%), and traditional trabeculectomy with mitomycin-C (14.1%). Most participants preferred non-bleb forming or conjunctiva-sparing procedures, even if they had low preop IOP levels. The study appears in Eye.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), 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

For sponsorship opportunities or membership information, contact: ASCRS • 4000 Legato Rd. • Suite 700 • Fairfax, VA 22033 • Phone: 703-591-2220 • Fax: 703-591-0614 • Email: ASCRS Opinions expressed in EyeWorld Weekly do not necessarily reflect those of ASCRS. Mention of products or services does not constitute an endorsement by ASCRS.

Click here to view our Legal Notice.

Copyright 2019, EyeWorld News Service, a division of ASCRSMedia. All rights reserved.