EyeWorld Weekly, October 7, 2022

EyeWorld Weekly, October 7, 2022

EyeWorld Weekly

October 7, 2022 • Volume 28, Number 39

FDA approves new therapy for amblyopia

NovaSight announced that it received FDA 510(K) clearance for the CureSight digital therapy for amblyopia. This technology, according to the company’s press release, trains both eyes simultaneously using eye tracking while the user watches any video content while wearing red-blue treatment glasses. CureSight blurs center vision in the strong eye, thereby encouraging the brain to “complete the image’s fine details from the amblyopic eye image.” The company’s pivotal trial of 103 participants (4–<9 years old) were randomized to use CureSight or the gold standard of eye patching. The study found CureSight to be non-inferior to patching, with 79% of patients having a BCVA improvement of 2 lines or more in their amblyopic eye (vs. 61% who were patched). Patient adherence to using their amblyopic treatment was 93% in the CureSight group.

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First-in-human data from IOL/drug-delivery platform

SpyGlass Pharma announced data from its first-in-human feasibility trial with 23 patients with glaucoma or ocular hypertension who had cataract surgery and received the company’s IOL with a drug-eluting component. According to the company’s press release, the IOL is a single-piece, hydrophobic acrylic that has bimatoprost-eluting pads on the haptics. Patients in the study were randomized to receive one of three doses of bimatoprost on the platform. At 3 months, mean IOP reduction across all groups was 45%, and all achieved an IOP of 18 mm Hg or lower without additional therapy. There were no serious adverse events, and visual outcomes were similar to those with other IOLs. SpyGlass stated that it plans to file an IND with the FDA within the next 12 months and, with clearance, will begin a Phase 1/2 clinical trial in the U.S. in 2023.

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Largest crosslinking study to date for keratoconus

CXL Ophthalmics announced publication of its EpiSmart crosslinking Phase 2 study for keratoconus, which included 1,922 patients with keratoconus. The company stated that this is the largest study of corneal crosslinking for keratoconus to date. The study evaluated the EpiSmart epi-on treatment, finding that 80% of patients maintained or improved CDVA within 12 months postop, 89% of patients 21 years and younger had stable or improved vision at 12 months, and visual improvements were similar to treatment with an epi-off technique with fewer adverse events. The results are published in the journal Cornea. According to the company’s press release, Phase 3 trials are planned to assess safety and efficacy of EpiSmart compared to placebo and sham control.

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Interim data for Phase 2 trial evaluating choroidal melanoma treatment

Aura Biosciences announced interim Phase 2 data from its trial evaluating suprachoroidal administration of belzupacap sarotalocan (AU 011) as a first-line treatment for early stage choroidal melanoma. According to the company’s press release, the study, which enrolled 20 patients who were assigned to different cohorts for single dose or multiple dose escalations, found that the treatment resulted in a statistically significant reduction in tumor growth rate, a high rate of visual acuity preservation, and a favorable safety profile.

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Gene therapy update

There have been several updates to gene therapies in the pipeline for ophthalmic diseases. Atsena Therapeutics announced positive Phase 1/2 clinical data for ATSN-101 for treatment of GUCY2D-associated Leber congenital amaurosis. The Janssen Pharmaceutical Companies of Johnson & Johnson announced results from a Phase 1/2 study of botaretigene sparoparvovec (AAV-RPGR) for X-linked retinitis pigmentosa, demonstrating a safety profile and suggesting sustained vision improvement, and a Phase 1 study showing all three doses of JNJ-1887 for geographic atrophy met primary safety endpoints.

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SLT trial seeking more clinical sites, deadline October 14

The Clarifying the Optimal Application of SLT Therapy (COAST) trial is seeking additional clinical sites. This randomized trial is designed to evaluate the safety and efficacy of standard vs. low-energy primary SLT for patients with mild to moderate open-angle glaucoma or ocular hypertension. It will also evaluate the optimal interval and energy for repeat SLT. Site selection is determined by ability to meet enrollment targets, diversity of participant population, previous clinical trial experience, etc. Learn more about the study, selection criteria, and application details here. 

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Acquisition news

Visus Therapeutics announced acquisition of patents and other assets from ViewPoint Therapeutics. According to the company’s press release, this acquisition includes an investigational cataract and presbyopia therapy based on an alpha-crystallin aggregation inhibitor. Drug candidate selection is anticipated in the first quarter of 2023.

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ASCRS news and events

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Research highlights

  • Safety and efficacy of a shape-changing, modular IOL (Juvene IOL, LensGen) was evaluated in an exploratory prospective multicenter, open-label, non-comparative clinical trial published in the Journal of Cataract & Refractive Surgery. The study included 51 of 58 eyes that completed the 12-month visit after receiving Juvene either bilaterally or unilaterally. There was one intraoperative complication (missed base lens tab), and the most frequent postop adverse events were prolonged inflammation (six cases) and CME (four cases); all resolved by 12 months postop. The mean monocular logMAR CDVA, DCIVA, and DCNVA were 0.01, 0.08, and 0.24, respectively. The authors reported that defocus testing put visual acuity at “>20/40 from approximately +1.00 through −2.00 diopters” and binocular use of the IOL was superior over monocular. 
  • Incidence, causes, and outcomes of the EVO ICL (STAAR Surgical) realignment or exchange was evaluated in a retrospective study that included 10,258 consecutive eyes that received the ICL from one center (Eye and ENT Hospital of Fudan University, China). ICL realignment or exchange was needed in 22 eyes (0.21%). Misalignment occurred in 12 eyes (10 of which had realignment with rotation and two of which had IOL exchange), while excessive vault required vertical rotation in three eyes and exchange in seven. The authors concluded that incidence of realignment and exchange after ICL implantation is low. They also stated that while exchange is an option for excessive vault or misalignment, vertical rotation could be less invasive to treat excessive vault in some cases. The research is published in the Journal of Cataract & Refractive Surgery.

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Product news

  • Remidio launched Instaref R20, a portable, handheld autorefractor. 
  • Ophthalmic images have been introduced to Verana Health’s VeraQ health data engine, which is incorporated into the AAO IRIS Registry.
  • The TECNIS Symfony OptiBlue IOL (Johnson & Johnson Vision) is now available in the U.S. and in certain countries within Europe, the Middle East, and Africa.
  • The Clareon Toric IOL (Alcon) has begun rolling out in the U.S., completing the Clareon Collection.
  • ImprimisRx launched topical Fortisite, a patent-pending compounded formulation of tobramycin 1.5% and vancomycin 5%.

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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: Sumit “Sam” Garg, 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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