- Combination pharmaceutical therapy being investigated for presbyopia meets study endpoints
- Positive results in Phase 2 clinical trial for IOP-lowering agent
- Phase 3 results from study of gene therapy for retinal neurodegenerative diseases
- Positive safety results in Phase 1 anti-VEGF treatment
- ASCRS news and events
July 9, 2021 • Volume 27, Number 27
Combination pharmaceutical therapy being investigated for presbyopia meets study endpoints
Ocuphire Pharma announced that it met primary and secondary endpoints with its Nyxol (0.75% phentolamine ophthalmic solution) combined with low-dose pilocarpine as a temporary treatment for presbyopia in a Phase 2 clinical trial. The combination therapy resulted in 61% of study participants gaining 15 or more letters (three lines) in near vision 1 hour after application. According to the company’s press release, efficacy of the combination pharmaceutical began at 30 minutes with near vision improvement through at least 6 hours. The reduction in pupil diameter lasted at least 18 hours. Ocuphire plans to initiate a Phase 3 trial.
Positive results in Phase 2 clinical trial for IOP-lowering agent
Nicox announced positive results from its Phase 2 clinical trial investigating NCX 470, a nitric oxide-donating prostaglandin analog. According to the company’s press release, the drug showed significantly greater IOP-lowering effects in patients with glaucoma compared to latanoprost. More than 400 patients with open angle glaucoma or ocular hypertension were enrolled in the study, receiving either NCX 470 0.065% or latanoprost 0.005%. According to the company, the patients in the NCX 470 group achieved superior IOP lowering at all time points with up to 1.4 mm Hg more IOP lowering by day 28. Nicox is currently in two Phase 3 trials that are evaluating efficacy of once-daily NCX 470 0.1% over latanoprost 0.005%. The results from these trials are expected in 2022.
Phase 3 results from study of gene therapy for retinal neurodegenerative diseases
GenSight Biologics announced positive topline results from its Phase 3 study of LUMEVOQ, a gene therapy targeting Leber hereditary optic neuropathy. According to the company’s press release, the study included data out to 1.5 years post-treatment, showing that bilateral injections of the gene therapy resulted in better visual acuity improvements compared to unilateral injection of it. A favorable safety profile for bilateral injections was confirmed in the study as well.
Positive safety results in Phase 1 anti-VEGF treatment
EyePoint Pharmaceuticals announced the positive safety results from the Phase 1 DAVIO clinical trial for its anti-VEGF therapy designed to be delivered twice yearly for wet AMD. The dose-escalation trial included 17 patients with wet AMD who reached at least 30 days post-dosing with EYP-1901 with no serious ocular or systemic adverse events. According to the company’s press release, EYP-1901 combines a bioerodible formulation of EyePoint’s Durasert sustained-release technology with vorolanib, a tyrosine kinase inhibitor.
ASCRS news and events
- ASCRS continues to advocate on behalf of its members regarding Aetna’s prior authorization of cataract surgery policy.
- The latest episode of the ASCRS Journal Club is online for viewing and claiming of CME credit now.
- There is still time to register for the ASCRS Annual Meeting July 23–27 in Las Vegas, Nevada. More rooms were recently added to the ASCRS discounted hotel block.
Research highlights
- A retrospective cohort study based off of IRIS Registry data evaluated the refractive outcomes of patients who had immediately sequential bilateral cataract surgery (ISBCS), short-interval (1–14 days) delayed sequential bilateral cataract surgery (DSBCS-14), and long-interval (15–90 days) delayed sequential bilateral cataract surgery (DSBCS-90). The investigators found that when compared to DSBCS-14 and DSBCS-90 outcomes, the ISBCS group had worse visual outcomes, which they acknowledged “may or may not be clinically relevant, depending on the patient’s additional risk factors.” More specifically, the researchers found that UCVA in the first eye was higher by 0.41 letters and BCVA was higher by 0.89 letters in the DSBCS-14 group compared to the DSBCS-90 group. The ISBCS group’s UCVA was lower by 2.79 letters and BCVA was 1.64 letters lower compared to the DSBCS-90 group. The second eye in the DSBCS-14 group had a UCVA that was 0.79 letters higher and BCVA was 0.48 letters higher than the DSBCS-90 group; the ISBCS group had UCVA that was 1.67 letters lower and BCVA was 1.88 letters lower than the DSBCS-90 group. The authors concluded that “nonrandom surgery group assignment, confounding factors, and large sample size could account for the small but statistically significant differences noted,” and said that further studies are needed to determine clinically relevant factors. The research is published in JAMA Ophthalmology.
- A randomized, controlled clinical trial conducted at Aravind Eye Hospitals evaluated whether corneal crosslinking was an effective adjuvant for treatment of bacterial keratitis. Eyes were randomized to receive either topical moxifloxacin 0.5% or topical moxifloxacin plus crosslinking. The eyes that received crosslinking in addition to moxifloxacin were 0.6 times less likely to have a positive culture at 24 hours, 0.8 logMAR worse visual acuity, and a 0.41-mm larger scar size at 3 months. There were fewer corneal perforations and less need for therapeutic PK in the group that had crosslinking. The authors concluded that they were unable to confirm a benefit of adjuvant crosslinking for bacterial keratitis. They stated that a larger trial is needed to evaluate if crosslinking can significantly reduce culture positivity and if it can reduce complication rates. The study is published in the journal Cornea.
Product news
- OASIS Medical announced that its OASIS TEARS PF PLUS is now available in a 10 mL, multiuse bottle designed to prevent contamination while maintaining a preservative-free formulation.
This issue of EyeWorld Weekly was edited by Stacy Jablonski and Liz Hillman.
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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