EyeWorld Weekly, May 9, 2025

Positive update from Phase 2 study evaluating oligonucleotide for AMD and DME

Isarna Therapeutics announced positive Phase 2 results from its trial evaluating ISTH0036 for treatment of wet AMD and DME, including its potential to address retinal fibrosis. According to the company’s press release, ISTH0036 via intravitreal injection every 8 weeks achieved a stable or improved BCVA and meaningful anatomical retina improvements. The company reported that all patient groups saw a reduction in central retinal thickness. There was a significant decrease in hyperreflective material volume in the group that received ISTH0036 compared to the anti-VEGF therapy. For patients with DME, intraretinal fluid volume was reduced in both treatment-naïve and previously anti-VEGF-treated eyes in the ISTH0036 group. ISTH0036 is a selective TGF-β2-blocking antisense oligonucleotide, which the company stated is a “key cytokine involved in fibrosis and disease progression in retinal pathologies.”

18-month data presented on novel drug delivery platform

SpyGlass Pharma announced 18-month data from its first-in-human study of the SpyGlass Drug Delivery platform, an IOL-based drug delivery for treatment of glaucoma or ocular hypertension. The single-center, prospective, cohort study of 23 patients with cataracts and glaucoma or ocular hypertension showed that patients’ BCDVA improved to between 20/16 and 20/30 at 18 months postop. Mean IOP was reduced from 25.1±2.5 mm Hg at baseline post-medication washout to 14.1±2.6 mm Hg at 18 months. Furthermore, all patients remained off all topical IOP-lowering medications. There were no product-related adverse events.

Phase 1/2a trial results for intravitreal injection for treatment of glaucoma

Perfuse Therapeutics announced positive 24-week results from its Phase 1/2a trial evaluating one intravitreal injection of PER-001 as a disease-modifying treatment for glaucoma. According to the company’s press release, PER-001 improved visual function and anatomic structure compared to the control in this timeframe. More specifically, patients treated with PER-001 had an increase in optic nerve head blood flow from baseline, an improvement in visual function mean deviation from baseline (this metric in the sham group worsened), and an increase in retinal nerve fiber lay thickness from baseline (this metric in the sham group decreased). The treatment was also found to be safe and well-tolerated, with two drug-related adverse events (floaters that were mild and self-resolved). The company described PER-001 as a “first-in-class small molecule endothelin receptor antagonist.”

Advancing AI to facilitate detection and improve management of ocular disease

Topcon, as part of its Healthcare from the Eye initiative, made several announcements within the past week. It launched the Institute of Digital Health (IDHea) as an “ocular data-as-a-service platform designed to accelerate AI research and digital health innovation.” The company stated that this platform is intended to “transform clinical data into actionable insights through AI-powered analytics and seamless connectivity.” Topcon, in collaboration with Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, also announced the creation of a new company, Cascader Limited, which is being created to use AI for the detection and management of eye disease and other systemic conditions. In addition, Topcon acquired RetInSight, a company involved with innovation in retinal imaging AI solutions.

Fast Track designation granted for neuropathic corneal pain

OKYO Pharma received an FDA Fast Track designation for urcosimod (OK-101), which is under investigation for treatment of neuropathic corneal pain.

Regenerative Medicine Advanced Therapy designation granted to investigational gene therapy

Opus Genetics announced that it received a Regenerative Medicine Advanced Therapy designation from the FDA for its gene therapy targeting Leber congenital amaurosis (LCA) due to genetic variations in the LCA5 gene. This designation, according to the company’s press release, is based on the early results from the Phase 1/2 open-label, dose-escalation trial using the OPGx-LCA5 gene therapy in patients with severe vision loss due to LCA5 gene mutations. The company reported that treatment benefits that were observed at 6 months have been sustained out to 1 year. These benefits include an improvement in cone-mediated vision (improvement in reading vision and object recognition).

ASCRS news and events

  • ASCRS Business of Refractive Cataract Surgery Summit: This course, taking place October 3–5, in Chicago, Illinois, along with its extensive, take-home resource library, will help practices gain the navigational tools needed to increase advanced-technology IOL adoption and lead patients effectively on their refractive surgery journey. Learn more.
  • ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2025. Registration is open for the next event in Chicago, Illinois, on June 12.
  • New ASCRS Cornea Clinical Committee Webinar:Antibody Drug Conjugates—An Emerging Class of Cancer Therapeutics Which Pose Risks to Corneal and Anterior Segment Health,” with moderators Naveen Rao, MD, and Winston Chamberlain, MD, along with speakers Kamran Riaz, MD, Stella Kim, MD, and Farooq Asim, MD, covers what antibody drug conjugates are, what they’re used for, complications and adverse reactions within the anterior segment associated with these drugs, and more.
  • 2026 ASCRS Annual Meeting: Hotel room blocks are now open for the 2026 ASCRS Annual Meeting, taking place in Washington, D.C., April 10–13, 2026.

Research highlights

  • A real-world data study published in the Journal of Cataract & Refractive Surgery evaluated the symptoms, etiology, and treatment of patients who were unhappy after receiving an EDOF IOL in cataract surgery. The retrospective case series included medical records from patients who received an EDOF IOL from July 2020 to July 2022 and who reported any dissatisfaction after surgery. The study included 202 patients, 354 eyes, 22.8% of which were dissatisfied. The most common complaint was blurred vision (94%), followed by photic phenomena (25.3%). The authors reported the etiologies for dissatisfaction were residual ametropia (51.8%), dry eye disease (26.5%), and PCO (12.0%). About 85% of eyes received treatments, such as artificial tears, glasses, or refractive surgery. After interventions, 5.9% were still dissatisfied.
  • The effect of physical exercise on IOP, studied with a sensor/implant that continuously monitored IOP, was evaluated in 10 participants with open-angle glaucoma. According to the paper published in the British Journal of Ophthalmology, patients rode a stationary bike for 10 minutes with a stepwise power increase up to 75 W (25 W increases every 2 minutes). IOP at baseline and at 2 minutes after the exercise concluded were recorded. The authors reported that the “average IOP increased from 15.4±1.3 mm Hg at baseline to 18.0±1.3 mm Hg at 75 W and returned to 14.4±1.0 mm Hg during the resting period after exercise.” They noted that during the resting period post-activity, the average IOP was reduced below baseline in most patients (80%). Systolic blood pressure and heart rate were correlated with IOP during exercise. The authors concluded, given the correlation between IOP, heart rate, and blood pressure increasing and decreasing with physical intensity, that there is potentially a common mechanism during aerobic exercise that could be studied in future studies with larger patient groups.

Product news

  • Bausch + Lomb received the CE Mark for its LuxLife Full Range of Vision IOLs, which are preloaded.

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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