EW Weekly, February 12, 2021

NDA filed for topical glaucoma and ocular hypertension ophthalmic solution
Santen and Ube Industries announced that the FDA accepted its NDA for STN10117 (DE-117), a topical ophthalmic solution under investigation for treatment of glaucoma and ocular hypertension. The company’s press release noted that the FDA plans to complete its review in November. The two companies are co-developing this agent, which includes omidenepag isopropyl as an active ingredient that provides a new mechanism of action as a selective EP2 receptor agonist, the press release explained. STN10117 (DE-117) ophthalmic solution 0.002% is marketed in Japan as EYBELIS and has received marketing approval in other Asian countries, according to the companies.

Nepafenac vs. placebo, results from Phase 2 study
Mati Therapeutics announced Phase 2 clinical trial results for its Evolute sustained ocular drug delivery platform of nepafenac vs. placebo. The randomized, multicenter, masked trial included 56 patients having cataract surgery. The primary endpoint was pain, with secondary endpoints being inflammation and postop visual acuity. Patients who received the nepafenac Evolute punctal plug, which was placed prior to cataract surgery, were more likely to be pain-free after surgery; 52% of patients in the nepafenac group were pain-free at all postop visits, while 0% achieved this in the placebo group. The press release noted reduced inflammation in the nepafenac group and significantly better visual acuity. The company stated that the device was well tolerated with no unexpected adverse effects.

Enrollment completed for photobiomodulation treatment trial
Enrollment is complete for LumiThera’s clinical trial of photobiomodulation with its Valeda Light Delivery System as a therapy for dry AMD. The study, which is taking place at 10 U.S. centers and enrolled 100 patients with dry AMD, is randomized, double-masked, and will follow patients out to 24 months. According to the company’s press release, primary endpoints are visual acuity, contrast sensitivity, and reduction of drusen deposits. The Valeda Light Delivery System has received the CE mark in Europe.

ASCRS activity updates
  • The 2021 ASCRS Annual Meeting will now take place in Las Vegas, Nevada, July 23–27. Registration opens February 22.
  • Check out the latest Ophthalmology Quicksand Chronicles podcast with hosts Nicole Fram, MD, and Elizabeth Yeu, MD, and guest Eric Donnenfeld, MD.
  • ASCRS Grand Rounds presented by Case Western Reserve University/University Hospitals will air February 17 beginning at 8 p.m. EST. It will be recorded for members to view after the event as well.

Research highlights
  • Perceived ergonomic stress differences between conventional optical operating microscopes vs. a heads-up display microscopic view were evaluated in an online survey of ophthalmic surgeons. The online questionnaire was completed by 27 posterior segment surgeons, 25 anterior segment, and two who operated in both areas. The surgeons surveyed had a mean of 14.9 years in practice and 2.3 years of using a heads-up display. Sixty-four percent agreed or strongly agreed that using a heads-up display reduced the severity of pain; 63% said it reduced the frequency of their pain. Seventy-three percent agreed that it improved posture and 77% that it improved overall comfort. Of survey respondents who had experienced headaches while operating, 44% said headaches improved; 82% who had pain and discomfort while operating said it was less after switching to heads-up. After analysis with a multivariate model, the investigators found that surgeons were 5.12 times more likely to experience improvement in pain symptoms when heads-up displays were used in more than 50% of their cases. The report is published in the journal Clinical Ophthalmology.
  • A retrospective analysis of patients who had endoscopic cyclophotocoagulation (ECP) combined with phacoemulsification compared to patients with phaco alone revealed an increased risk for persistent anterior uveitis with ECP plus phaco. The review, which included these procedures from Jan. 1, 2014, to Dec. 31, 2017, had investigators look at visual acuity, IOP, anterior chamber cells, and steroid use preop and postop. The investigators noted that patients with a history of uveitis, autoimmune disease, complicated phaco, or a case combined with another surgery and ECP were excluded. More than 4,400 eyes were included from more than 2,900 patients. Persistent anterior uveitis was seen in 14.9% of eyes that had the combined phaco and ECP compared to 1.7% in the eyes that received phaco alone. White patients were at increased odds of developing this in a combined phaco-ECP procedure, the authors noted, though they had a lower rate of persistent anterior uveitis. The research is published in the journal Clinical Ophthalmology.
  • A longitudinal observational study published in the journal Ophthalmology described research that sought to evaluate self-reported alcohol consumption (and alcohol type) to incident cataract surgery. The research used data from participants in the UK Biobank and the EPIC-Norfolk database. Overall, there were 19,011 incident cataract surgery cases in the UK Biobank and 4,573 from EPIC-Norfolk. The researchers noted that those who had self-reported alcohol consumption were less likely to have cataract surgery compared to non-drinkers. When looking at type of alcohol consumed, the researchers report wine consumption being associated with a lower risk of incident cataract surgery. The study authors concluded that there could be “a lower risk of undergoing cataract surgery with low to moderate alcohol consumption. The association was particularly apparent with wine consumption.” The researchers noted that this association is not necessarily causation; further investigation would be required.

Product news
  • Johnson & Johnson Vision is celebrating its 20th anniversary with the TECNIS IOL platform.
  • Heine is launching a new indirect ophthalmoscope, the Omega 600.
  • Bausch Health and Nicox announced the approval in South Korea of Vyzulta (latanoprostene bunod ophthalmic solution).

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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