- Launch of IOL made with new ‘glistening-free’ material
- Enrollment complete in study of mydriasis-reversing drop in a pediatric group
- Acquisition of electrophysiology medical device company
- Licensing of investigational neuroprotective drug
- ASCRS news and events
March 11, 2022 • Volume 28, Number 10
Launch of IOL made with new ‘glistening-free’ material
Alcon announced the U.S. launch of Clareon IOLs, a family of IOLs made from a new “glistening-free” material that also, according to the company, offers lower levels of haze and subsurface nanoglistenings. The company’s monofocal, PanOptix, PanOptix Toric, Vivity, and Vivity Toric are now available on the Clareon platform. A Clareon monofocal toric will be available later this year. The company’s press release also described new delivery systems for these IOLs, the reusable Clareon Monarch IV Delivery System and the single-use, preloaded, automated AutonoMe system, as well as other IOL-specific properties.
Enrollment complete in study of mydriasis-reversing drop in a pediatric group
Ocuphire Pharma announced that it completed enrollment for its MIRA-4 trial, which is evaluating Nyxol (phentolamine) eye drops for mydriasis reversal in 23 pediatric patients. Patients included in the study are between 3–11 years old. The MIRA-3 Phase 3 clinical trial in adults and older children (12–17 years old) is also underway. According to the company, there is currently no dilation reversal therapy on the market. If these studies are successful, the company stated in a press release that it plans to submit a New Drug Application to the FDA in late 2022.
Acquisition of electrophysiology medical device company
LumiThera, which offers photobiomodulation with its Valeda Light Delivery System (not yet approved in the U.S.) for dry AMD, completed acquisition of Diopsys, a company creating visual electrophysiology medical devices for analysis of the entire visual pathway. This acquisition, the company stated in a press release, complements its treatment platform with diagnosis and monitoring, using electroretinography, which measures electrical activity in the retina in response to light stimulus.
Licensing of investigational neuroprotective drug
Oculis announced that it entered into a licensing agreement with Accure Therapeutics that grants it exclusive rights to develop and commercialize ACT-01. The company’s press release described ACT-01 (being renamed OCS-05) as a potentially disease-modifying therapy intended to prevent damage to the optic nerve and retina. This investigational agent is a first-in-class small molecule that has already shown positive results in animal models, with a mechanism of action related to activation of the trophic factor pathways, which can protect nerve axons, according to the company. A Phase 2a study with this drug is underway in France.
ASCRS news and events
- 2022 ASCRS Annual Meeting: Register for the ASCRS Annual Meeting in Washington, D.C., April 22–26. The last day of Tier 2 registration pricing is March 16.
- Eyecelerator@ASCRS: Registration is open for Eyecelerator@ASCRS, taking place April 21 ahead of the ASCRS Annual Meeting in Washington, D.C.
- Beyond 20/20: Beyond 20/20: An ASCRS Series in Modern Refractive Surgery and Presbyopia Therapy is a new, four-part educational series sponsored by the Refractive Clinical Committee that features CME and non-CME components. Learn more about the series and register here.
- ASCRS Grand Rounds: The first ASCRS Grand Rounds of 2022, presented by NYU Langone Department of Ophthalmology, is available on demand.
Research highlights
- The Phase 3 randomized, vehicle-controlled study of AGN-190584, pilocarpine hydrochloride, currently marketed as Vuity (Allergan) for temporary treatment of presbyopia, was published in JAMA Ophthalmology. The GEMINI 1 study enrolled 323 participants who received AGN-190584 or vehicle drops. According to the study, those who received AGN-190584 saw superior gains in mesopic DCNVA at day 30, hours 3 and 6, compared to vehicle. The percentage of participants who used the drops with the active ingredient with 3 lines or better improvement of mesopic DCNVA was 30.7% compared to 8.1% with the vehicle at 3 hours. At 6 hours after instillation, 18.4% of participants in the study group had a 3 line or greater improvement, compared to 8.8% in the control group. While no statistical difference was observed at hour 8, the authors wrote that there were clinically relevant differences. No participants who achieved 3 lines or greater improvement at hour 3 had losses of more than 5 letters in mesopic, high-contrast, BCDVA, according to the paper. The authors reported seeing effect of the presbyopia-mitigating agent at 15 minutes after instillation and found an “acceptable safety and tolerability profile.”
- The efficacy of the antiparasitic drug ivermectin against Demodex blepharitis was the topic of a retrospective case-controlled study published in the journal Cornea. One hundred and two eyes symptomatic for Demodex blepharitis were divided into two groups—51 received topical ivermectin cream, applied on the eyelashes for 15 minutes once weekly, in addition to eyelid hygiene performed once daily. The other 51 performed eyelid hygiene once daily. According to the paper, after a mean follow-up of 15.1±9.7 and 14.8±8.6 weeks in the ivermectin and control groups, respectively, the SPEED score and eyelid debris grade improved significantly in both groups, with greater changes in the ivermectin group. Oxford staining score, eyelid redness/swelling, and telangiectasia grade were significantly improved in the ivermectin group only. The researchers concluded that this once weekly, 15-minute application of topical ivermectin cream was efficacious for Demodex blepharitis patients compared to eyelid hygiene alone.
Product news
- EYSUVIS (loteprednol etabonate ophthalmic suspension, Kala Pharmaceuticals), approved for up to 2 weeks of treatment for the signs and symptoms of dry eye disease, is now covered by UnitedHealthcare and Cigna Medicare.
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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