EW Weekly, October 11, 2019

Topline results announced from Phase 2 trial with NCX 470 for glaucoma
Topline results from a Phase 2 trial of NCX 470 (Nicox) for glaucoma showed statistical superiority to latanoprost in a prespecified secondary efficacy analysis, according to a Nicox press release. NCX 470 is a second-generation nitric oxide-donating bimatoprost analog that was compared in the trial to latanoprost ophthalmic solution (0.005%) in 433 patients with open-angle glaucoma or ocular hypertension. In the primary efficacy analysis, statistical noninferiority was met vs. latanoprost. The IOP-lowering effect of NCX 470 from baseline was 7.6–9.8 mm Hg vs. 6.3–8.8 mm Hg for latanoprost. The most frequent adverse event was conjunctival hyperemia, which occurred in 16.8% of NCX 470 patients vs. 6.5% of latanoprost patients. No drug-related serious adverse events occurred. Company leaders plan to meet with the U.S. FDA early next year to finalize plans for Phase 3 trials against a prostaglandin analog.           

First patient dosed in trial for OCS-01 for pain after cataract surgery
The first patient has been dosed in a Phase 2b clinical trial for OCS-01 (Oculis), designed to treat inflammation and pain after cataract surgery, according to a company press release. The prospective, multicenter, randomized trial will focus on the efficacy and safety of OCS-01 and is underway at 20 ocular surgery centers around the U.S. OCS-01 is a topical formulation of dexamethasone that uses the company’s proprietary Solubilizing NanoParticle technology platform.

FDA approves BEOVU for wet AMD
The FDA approved BEOVU (brolucizumab-dbll, Novartis) for wet age-related macular degeneration (AMD), according to a company press release. The drug is also known as RTH258. Approval was based on findings from the Phase 3 HAWK and HARRIER clinical trials, which showed BEOVU’s noninferiority vs. aflibercept (Eylea, Regeneron Pharmaceuticals) in mean change in best-corrected visual acuity at 1 year. The most common adverse events with BEOVU were blurred vision, cataract, conjunctival, hemorrhage, vitreous floaters, and eye pain, which occurred in 5% or fewer patients, according to the company.

Phase 2b trial begins for GB-102 for wet AMD
A Phase 2b clinical trial called ALTISSIMO is underway with the agent GB-102 (Graybug Vision) in patients with wet AMD. GB-102 is a pan-vascular endothelial growth factor receptor inhibitor and potentially a twice a year therapy. It is targeted to lower the need for frequent intravitreal injections for wet AMD, diabetic macular edema, and retinal vein occlusion, according to the company. The Phase 2 trial is a 12-month, three-arm study to assess two dose levels of GB-102 (1 mg and 2 mg) given every 6 months compared to aflibercept (2 mg) given every 2 months. There will be 160 patients in the trial at more than 100 clinical centers across the U.S.

ASCRS and AAO launch a series of ‘next-generation’ business innovation conferences
ASCRS and AAO announced this week their collaboration to develop a series of business forums that bring together industry, ophthalmologists, scientists, entrepreneurs, executives, and investors with the goal of nurturing businesses that have a hand in innovating for ophthalmology. According to a joint press release from ASCRS and AAO, the innovation forums will be held in conjunction with the ASCRS and AAO annual meetings. The first will take place May 14, 2020, in Boston at the ASCRS Annual Meeting. “It’s clearly time for both the Academy and ASCRS to develop a next-generation ophthalmic business forum, given the power of these two societies to bring together the top minds in ophthalmology and business,” Steve Speares, ASCRS executive director, said in the press release. AAO CEO David Parke, MD, called the collaboration a “unique opportunity to benefit patients around the world.”

Submit your nomination for the inaugural ASCRS Educator Award
The new ASCRS Educator Award recognizes an ASCRS member who has made education an enduring career priority. Nominees must: have demonstrated passion and commitment to education, leadership, and selflessness in the pursuit of expanding knowledge in the interest of improving patient outcomes; be an ophthalmologist focused on anterior segment surgery; have at least 5 years in practice; and be a current ASCRS member.
Nominations are due by November 29. Find more information at ascrs.org/educatoraward.

Research briefs
  • In a randomized clinical study, brinzolamide lowered the short-term IOP increase after cataract surgery more effectively than travoprost or timolol in eyes with glaucoma, according to Ken Hayashi, MD, and coresearchers. The study included 165 eyes of 165 patients with primary open-angle glaucoma or pseudoexfoliation glaucoma scheduled for phacoemulsification. Patients were randomly assigned to one of three groups to receive travoprost, timolol maleate, or brinzolamide immediately postop. IOP was measured at 1 hour preop, right after surgery, and at 2, 4, 6, 8, and 24 hours postop. The mean IOP did not differ significantly among groups at 1 hour before surgery or immediately at the end of surgery. The mean IOP increased significantly between 4 and 8 hours postop and then lowered at 24 hours postop in all groups (P<.0001). The mean IOP was significantly lower in the brinzolamide group than the travoprost and timolol groups at 4, 6, and 8 hours after surgery. There were no significant differences among groups at 2 and 24 hours postop. There was a significantly lower chance of an IOP spike in the brinzolamide group than in the travoprost and timolol groups (P = .0029). The research is published in the American Journal of Ophthalmology.
  • In treated normal tension glaucoma (NTG) patients, working on a smartphone under a low-light condition can cause an IOP elevation, with smaller elevations noted in patients with previous trabeculectomy, reported Ahnul Ha, MD, and coresearchers. This study focused on the effect of reading or writing on a smartphone and IOP change in eyes with NTG. It also assessed whether glaucoma filtering surgery could affect IOP fluctuation during such work. Forty eyes of 40 NTG patients with medically well-controlled IOP and 38 eyes of 38 NTG patients with previous trabeculectomy were included. Participants read a sample text and then typed on a smartphone under low-light (100 lux) conditions. IOP measurements were obtained at baseline, at 5, 15, and 25 minutes during smartphone work, and at 5 and 15 minutes post-work. After 5 minutes of working on a smartphone, IOP for the medication group was significantly elevated (15.5 mm Hg compared with 13.9 mm Hg at baseline) and showed further increases over 25 minutes (17.5 mm Hg). Five minutes after stopping work, the IOP dropped below baseline to a mean of 13.1 mm Hg. The IOP also was elevated after 5 minutes in the surgical group (14.9 mm Hg compared with 13.6 mm Hg at baseline); however, there was no further increase over 25 minutes of work. The research appears in the British Journal of Ophthalmology.
  • In a retrospective study of two different datasets, second-eye refinement via formula-specific predicted postop refraction adjustment or patient-specific IOL constant adjustment increased the percentage of patients who achieved the refractive target with their second eye, according to Andrew Turnbull, MD, and Graham Barrett, MD. Their study included 139 patients who had delayed sequential bilateral cataract surgery in Australia. Prediction error was determined by comparing the postop subjective refraction with the predicted postop refraction calculated by the Barrett Universal II, Hoffer Q, Holladay I, and SRK/T formulas. Separately, patient-specific optimized IOL constants were determined from first-eye phaco and applied to second-eye calculation. The adjustments were applied to a dataset of 605 patients in the U.K. to test validity. The Australian-derived adjustment coefficients based on prediction error ranged from 0.30–0.56, depending on the formula. Within the U.K. dataset, the percentage of patients within 0.50 D of predicted postop refraction adjustment with their second eye improved from 70.74%, 65.29%, 69.09%, and 67.77% with the Barrett Universal II, Hoffer Q, Holladay I, and SRK/T, respectively, to 72.73%, 68.76%, 71.57%, and 72.56%, respectively. Patient-specific optimized IOL constants from the first eye had similar efficacy to formula-specific adjustment. The research is published 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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