- Cataract surgery survey results
- FDA approves first non-degradable, synthetic tissue for ophthalmic surgery
- New cyclosporine ophthalmic solution approved for dry eye
- Results from Phase 2b study of drug-eluting contact lens
- 12-month topline data for intravitreal implant in wet AMD trial
- AAV capsid licensed for ocular gene therapy indication
- ASCRS news and events
June 16, 2023 • Volume 29, Number 24
Cataract surgery survey results
During this Cataract Awareness Month, Alcon released the results from the Alcon Eye on Cataract Surgery Survey, which it conducted between March and April 2023 in several countries, including the U.S. The survey evaluated vision and cataract insights among participants who were 50+ who were either pre-cataract surgery, post-cataract surgery, or had not yet received a cataract diagnosis. Some of the survey’s findings included that 51% of participants 50+ understand they can choose from different types of IOLs to fit their visual needs, 58% recognize that cataract surgery involves a permanent lens implant, and more than a quarter did not realize the short recovery time associated with cataract surgery.
FDA approves first non-degradable, synthetic tissue for ophthalmic surgery
CorNeat Vision announced FDA 510(k) clearance of EverPatch. According to the company, EverPatch is the “first synthetic, non-degradable tissue-integrating matrix” approved for ophthalmic surgery. The company described it as being made of a non-woven polymer matrix that can reinforce sclera and aid in reconstruction of the ocular surface. The company further stated that EverPatch is thinner than processed patch tissue and can handle suturing. The product will launch in the U.S. in the third quarter of this year.
New cyclosporine ophthalmic solution approved for dry eye
Novaliq announced FDA approval of Vevye (cyclosporine ophthalmic solution formerly known as CyclASol) 0.1% for treatment of signs and symptoms of dry eye. According to the company’s press release, efficacy with the drop begins after 4 weeks of use. The press release reported that Vevye is designed to address the inflammatory cause of dry eye signs and symptoms in a novel, water-free, preservative-free product with no associated pH or osmolarity.
Results from Phase 2b study of drug-eluting contact lens
MediPrint Ophthalmics announced completion of its Phase 2b study in group 1 (low dose group) using its drug-eluting contact lens for glaucoma. According to the company, this is the first of potentially three doses that use LL-BMT1, a weekly contact lens that releases preservative-free bimatoprost for open angle glaucoma or ocular hypertension. The study is designed to assess dose optimization for the contact lens. Participants in the study wore the low-dose version of LL-BMT1 in each eye for 7 days continuously for 3 weeks. Results were compared to a reference arm where participants used topical timolol 0.5% twice daily for 3 weeks. IOP reduction with the contact lens was about 5.5 mm Hg (19% at 3 weeks), which the company’s press release stated was comparable to the reference treatment. Interim analysis did not find any serious treatment-related adverse events; the lenses were well tolerated.
12-month topline data for intravitreal implant in wet AMD trial
Ocular Therapeutix announced topline, 12-month data from its Phase 1 trial evaluating its intravitreal hydrogel implant of axitinib (OTX-TKI) for treatment of wet AMD. According to the company’s press release, this “bioresorbable” implant delivers a tyrosine kinase inhibitor, and in 12-month data showed maintenance of controlled wet AMD with a single injection of OTX-TKI that was comparable to aflibercept injections every 8 weeks. The company reported that four participants received rescue therapy at month 12, which the company explained indicates a waning effect of the therapeutic and helps establish a possible re-dosing timeline. There were no drug-related ocular or systemic adverse effects. The first pivotal trial for OTX-TKI for wet AMD could be initiated as early as the third quarter of 2023, according to the company. In a separate notice, the company also announced completion of enrollment for its Phase 1 study evaluating OTX-TKI with Elutyx technology for treatment of diabetic retinopathy. Six-month data from this study is expected in the first quarter of 2024.
AAV capsid licensed for ocular gene therapy indication
Adverum Biotechnologies has licensed its AAV.7m8 intravitreal vector capsid to Ray Therapeutics for its RTx-015 asset, which is the company’s lead candidate for retinitis pigmentosa therapy. According to the company’s’ press release, the goal for this therapy is to restore vision independent of the genetic condition causing the disease.
ASCRS news and events
- ASCRS Summer Meeting: The ASCRS Summer Meeting in Nashville, Tennessee, returns August 11–13. Early bird registration pricing is ongoing through June 26.
- ASCRS Podcast: Ophthalmology Quicksand Chronicles—Eureka Moments has posted a bonus episode, which was recorded in the ASCRS Tap Room at the 2023 ASCRS Annual Meeting.
- Cataract Awareness Month: June is Cataract Awareness Month. Follow ASCRS on social media to keep up with the latest on this important awareness effort.
Research highlights
- Higher levels of certain types of lipids were implicated in glaucoma pathogenesis in research that was published in the journal Nature Communications. According to the study, investigators sought to identify plasma metabolites that were associated with POAG risk. They used blood samples from the Nurses’ Health Studies and Health Professionals’ Follow-Up Study, following the participants and confirming who developed POAG. Metabolic profiling was performed on the blood samples of selectively matched controls. Three hundred and sixty-nine metabolites were linked to glaucoma cases. From there the authors compared their findings to the U.K. Biobank metabolomics data for patients who had glaucoma. Of the 369 metabolites in 39 different classes, five lipids were identified as having “a nominal adverse association with POAG,” release, after adjusting for known risk factors, a press release about the research stated. The classes of metabolites were studied in relation to POAG, and diglycerides and triglycerides were associated with POAG, with adverse reactions being stronger in glaucoma patients who had paracentral vision loss. The investigators plan to conduct further research on core lipoprotein carriers and lipid metabolism studies in glaucoma patients and seek to better understand the possible associations with glaucoma genetic risk scores.
- The long-term, 5-year results using a double-flanged polypropylene technique for fixation of a capsular tension segment, a nonfoldable IOL for scleral fixation, or a foldable IOL for scleral fixation were published in the Journal of Cataract & Refractive Surgery. Data from 71 eyes (61 patients) that had this technique used from September 2016 through December 2021 were evaluated for logMAR visual acuity and complications. According to the study, there were 13 cases of sub-Tenon flanges, five exposed flanges presenting after a mean of 1.8 weeks postop, one patient with large flanges that presented with conjunctival inflammation and hyperemia, two late internalized flanges, and two recent internalized flanges. Three eyes had retinal detachment, and CME was detected in three eyes. No cases of endophthalmitis occurred. The authors concluded that the technique was stable when performed correctly and noted complications that can occur, especially in the setting of short scleral tunnels and when the flanges are not buried adequately in sclera.
Product news
- Bausch + Lomb launched PreserVision AREDS 2 Formula with CoQ10, a soft-gel vitamin intended to reduce risk of AMD progression and support heart health.
This issue of EyeWorld Weekly was edited by Stacy Jablonski, Liz Hillman, and Ellen Stodola.
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: Sumit “Sam” Garg, MD, Chief Medical Editor, Mitchell Weikert, MD, Cataract Editor, Karolinne Rocha, MD, PhD, Refractive Editor, Julie Schallhorn, MD, Cornea Editor, Manjool Shah, MD, Glaucoma Editor
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