- FDA grants IDE for MIGS device to start pivotal trial
- Breakthrough therapy designation granted for possible Stargardt treatment
- Refractive surgery uptick continues
- First patient dosed in trial for light-activated optogenetic monotherapy for RP
- Diagnostic device company acquires ophthalmic device manufacturer
- Two ophthalmic companies partner
- ASCRS news and events
July 23, 2021 • Volume 27, Number 29
FDA grants IDE for MIGS device to start pivotal trial
iSTAR Medical announced that the FDA granted an investigational device exemption (IDE) for its MINIject pivotal trial, which will include more than 350 patients with POAG. According to the company’s press release, the trial will evaluate mean IOP reduction and proportion of patients achieving at least a 20% reduction in IOP. The trial will involve the MINIject procedure alone, not in combination with cataract surgery. According to the company, results from the study will be available after patients have completed 2 years of follow-up.
Breakthrough therapy designation granted for possible Stargardt treatment
Alkeus Pharmaceuticals announced that it was granted FDA breakthrough therapy designation for ALK-001 (C20-D3-vitamin A) for Stargardt disease. ALK-001, according to the company’s press release, is a chemically modified form of vitamin A that could treat multiple degenerative retinal diseases. As an investigational therapy, it is taken once a day, and clinical data has indicated that it can slow the progression of Stargardt disease.
Refractive surgery uptick continues
The Refractive Surgery Council reported 82% year-over-year growth in laser vision correction and more than 230,000 LASIK, SMILE, and PRK procedures occurring in the second quarter of 2021. The council’s press release stated this is a 200% increase over Q2 in 2020, which was the height of the pandemic shutdown of many medical procedures that were not of immediate necessity.
First patient dosed in trial for light-activated optogenetic monotherapy for RP
Nanoscope Therapeutics announced that the first patient was dosed in its Phase 2b trial for an ambient light-activatable optogenetic monotherapy intended for patients who have lost vision due to retinitis pigmentosa (RP). According to the company’s press release, the trial for MCO-010, a therapy that uses an AAV2 vector to deliver multi-characteristic opsin genes into retinal cells, will enroll 27 patients for a single injection of the treatment or sham. Safety, tolerability, and efficacy will be assessed. Enrollment completion is expected by the end of 2021 with 12-month results by the end of 2022.
Diagnostic device company acquires ophthalmic device manufacturer
Topcon Corporation announced its acquisition of VISIA Imaging, which the company’s press release stated will enhance Topcon’s development and manufacturing of anterior segment devices and software.
Two ophthalmic companies partner
ParagraphNovaBay Pharmaceuticals, which commercializes Avenova (hypochlorous acid), and ImprimisRx, an ophthalmology focused compounding pharmacy, announced a partnership in which ImprimisRx will provide NovaBay with sales, marketing, and distribution support for Avenova.
ASCRS news and events
- 2021 ASCRS Annual Meeting: The ASCRS Annual Meeting begins in Las Vegas today, July 23, with ASCRS Subspecialty Day. Keep up with Annual Meeting events through July 27 on social media and with #ASCRS2021.
- 2022 housing opens: Hotels for the 2022 ASCRS Annual Meeting, April 22–26, in Washington, D.C., opened today. Click here to see the hotel map and book your housing for the 2022 Annual Meeting.
Research highlights
- Research from randomized clinical trials of MIGS for treatment of open-angle glaucoma were reviewed in a meta-analysis to determine efficacy and safety. According to the research published in JAMA Ophthalmology, six Cochrane reviews were identified, which included data on iStent (Glaukos), Hydrus (Ivantis), Trabectome (Microsurgical Technology), subconjunctival and supraciliary drainage devices, and endoscopic cyclophotocoagulation. The data found that Hydrus could safely increase the likelihood of drop-free glaucoma control during a medium-term follow-up and resulted in 2 mm Hg greater IOP lowering than cataract surgery alone. iStent could also improve drop-free glaucoma control, but the authors noted it had a shorter-term IOP lowering effect. CyPass (Alcon), which was recalled from the market, was cited as improving drop-free glaucoma control compared to cataract surgery alone. The authors concluded that “among the products currently available, randomized clinical trial data associate Hydrus with greater drop-free glaucoma control and IOP lowering than iStent; however, these effect sizes were small.”
- A comparative study published in the journal Clinical Ophthalmology evaluated performance of the AcrySof IQ PanOptix trifocal IOL (Alcon) to the TECNIS Symfony extended depth of focus IOL (Johnson & Johnson Vision). The study included 221 eyes, 83 of which received PanOptix, 30 PanOptix toric, 70 Symfony, and 38 Symfony toric. At 1 month postop, average UNVA was 0.16±0.14 logMAR in the PanOptix group and 0.21±0.14 logMAR in the Symfony group. UDVA was 0.09±0.13 logMAR and 0.10±0.14 logMAR in the PanOptix and Symfony groups, respectively, while CDVA was 0.02±0.05 logMAR and 0.00±0.04 logMAR in those respective groups. At 3 months, the authors noted no statistical difference in UNVA, UDVA, or CDVA between the groups. There was no statistical difference in secondary outcome measures (glare, halo, dryness, night vision problems) at either of the timepoints between the groups.
Product news
- Amneal Pharmaceuticals’ generic version of TobraDex (Novartis), dexamethasone and tobramycin ophthalmic suspension, received abbreviated new drug application approval from the FDA.
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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