EW Weekly, February 14, 2020

Reduction found in vision-threatening events after 2-year use of aflibercept for DR
In the Phase 3 PANORAMA trial, aflibercept (EYLEA, Regeneron Pharmaceuticals) was able to reduce vision-threatening events by 75% over 2 years of use in patients with moderately severe to severe non-proliferative diabetic retinopathy (DR), according to a company news release. In the untreated sham arm of patients, 58% developed a vision-threatening complication or center-involved diabetic macular edema within 2 years after entering the trial. Enrolling 402 patients, PANORAMA includes an observational sham injection group and two EYLEA treatment groups dosed every 8 weeks after five initial once-a-month doses or every 16 weeks after three initial monthly doses and one 8-week interval. The 8-week interval group was switched to as-needed dosing at week 52. Patients were followed until week 100. Those who were treated at regular intervals had a greater benefit in the 2-year results, according to the company. One-year results from the PANORAMA trial have been presented previously.

Phase 1 study: THR-687 for DME well-tolerated and safe
Topline results were announced from a Phase 1 trial of THR-687 (Oxurion NV) for diabetic macular edema (DME), according to a company news release. The open-label, multicenter, single-dose escalation study focused on the safety of one intravitreal injection of three increasing doses of THR-687 (0.4 mg, 1.0 mg, and 2.5 mg) to treat DME. Those in the study had a history of response to prior antivascular endothelial growth factor and/or corticosteroid treatment and remained responsive to treatment, according to the news release. THR-687 was well-tolerated and safe, with no serious adverse events. A rapid onset of action in mean best corrected visual acuity (BCVA) also occurred from day 1, with an increase of 3.1 letters. This improved to 9.2 letters at month 1, and a mean BCVA improvement of 8.3 letters occurred at month 3 after a single injection of THR-687.

Phase 2 study of OCS-01 for DME provides proof of concept
Phase 2 study results for OCS-01 (Oculis) for DME provide proof of concept for OCS-01’s effect on DME. OCS-01 is an eye drop formulation of dexamethasone that uses the company’s proprietary Soluble NanoParticle technology. The prospective, multicenter, randomized, double-masked, vehicle-controlled DX-211 study included type 1 or 2 diabetes patients with DME. Among the 133 patients who completed the study, the mean central macular thickness had a greater decrease from baseline in the OCS-01 group compared with the vehicle arm at week 12. The mean change in Early Treatment Diabetic Retinopathy Study BCVA letter score from baseline to week 12 was higher in the OCS-01 group than the vehicle group (+2.62 letters versus +1.04 letters, P=0.125). Increases in IOP were more common with OCS-01 than with vehicle.

Phase 1b study finds efficacy with extended dosing intervals for KSI-301 for wet AMD
An ongoing Phase 1b study of KSI-301 (Kodiak Sciences) for wet age-related macular degeneration (AMD), DME, and retinal vein occlusion found strong efficacy with extended dosing intervals and no cases of intraocular inflammation after 420 doses in 130 patients. Eighty-four percent of the wet AMD-treated eyes and 76% of the DME-treated eyes were extended to 4 months or longer before their first retreatment. Fifty-five percent of wet AMD eyes and 64% of DME eyes were extended to 6 months. Among retinal vein occlusion, more than 50% of patients were extended beyond 3 months after three loading doses without receiving retreatment.

Santen, Verily to collaborate for ophthalmology devices
Santen Pharmaceuticals and Verily announced that they will enter a joint venture to apply microelectronics and scalable digital technologies to ophthalmology, according to a news release. This will include treatments for glaucoma and dry eye.

Research briefs
  • In a multicenter, cost-effectiveness trial, femtosecond laser-assisted cataract surgery (FLACS) was not superior to standard phacoemulsification and did not have additional benefits for patients or healthcare systems, according to Cedric Schweitzer, PhD, and coresearchers. Their participant-masked, randomized superiority trial compared FLACS and phaco in two parallel groups at five French University Hospitals among patients eligible for unilateral or bilateral cataract surgery. Outcome assessors, technicians, and patients were masked to the surgical treatment used; a sham laser procedure was devised for participants randomly assigned to the standard phaco arm of the study. The primary clinical endpoint was the surgical success rate, which was defined as a composite of four outcomes at a 3-month postop visit. The primary economic endpoint was the incremental cost per additional patient having treatment success at 3 months. There were 704 eyes in the FLACS group and 685 eyes in the phaco group. No significant differences in surgical success rates were found between the FLACS and standard phaco groups. Standard phaco was more cost effective. The study is published in The Lancet.
  • Assessment of inflammation after cataract surgery may have a role in predicting cystoid macular edema (CME) risk and may help titrate treatment duration and intensity related to the surgical inflammatory response, according to Michele De Maria, PhD, and coresearchers. They reviewed 187 prospective trials focused on anterior chamber inflammation and the risk of pseudophakic CME. In 51% of the studies, inflammation was assessed by clinical grading, followed by laser flare and cell photometry (42%) and aqueous humor sample (4%). Laser flare and cell photometry correlated with CME frequency more than other methods that the researchers analyzed. An evaluation of the connection between anterior chamber inflammation and CME risk requires the use of quantitative analysis methods of the inflammatory response after surgery, the researchers wrote. The research appears in Clinical Ophthalmology.
  • The use of a patterned membrane incorporated onto a hydrophobic acrylic IOL’s posterior surface was able to significantly reduce posterior capsule opacification in an experimental study compared with a commercially available control IOL, according to Nathan Ellis, MD, and coresearchers. The pattern, made by ClearSight, had unique discontinuous features that allowed for focal adhesions to be precisely guided, helping to control cell migration. The study included 12 New Zealand rabbits who had bilateral phaco and implantation of a ClearSight unpatterned IOL (Group 1), a ClearSight Sharklet-patterned IOL (Group 2), or a commercially available IOL as the control (Group 3), with a total of eight IOLs in each group. The rabbits were killed humanely, and had their globes enucleated. Capsular bag opacification was analyzed with the Miyake-Apple view, and the eyes had histopathology performed. The mean postmortem central posterior capsular opacification was 1.87 in Group 1, 1.06 in Group 2, and 3.14 in Group 3. The peripheral posterior capsular opacification was 2.18 in Group 1, 1.5 in Group 2, and 3.57 in Group 3. Comparisons of central and peripheral posterior capsular opacification were statistically significant between Groups 2 and 3 but not between Groups 1 and 3. The research appears in the Journal of Cataract & Refractive Surgery.

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

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