One-year data from first-in-human drug eluting IOL

Spyglass Pharma announced 1-year follow-up data from the first-in-human study of its intraocular lens designed to elute bimatoprost. Twenty-three patients with glaucoma or ocular hypertension completed follow-up. All three dose levels showed enduring IOP lowering with a mean pressure reduction of 44.6% compared to baseline, after a medication washout. On average, IOPs at 12 months were 18 mm Hg or less. All patients were off topical IOP-lowering drops. The company is currently enrolling patients in a Phase 1/2 study.

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Company begins two Phase 2 studies for glaucoma treatment

Qlaris announced that it is beginning two separate Phase 2 masked, randomized clinical trials evaluating QLS-111 for patients with glaucoma or ocular hypertension. According to the company’s press release, one study will assess the safety, tolerability, and optimal dose of QLS-111 compared to vehicle alone in patients with primary open angle glaucoma or ocular hypertension, with IOP lowering being a secondary endpoint. A second study will assess safety and tolerability and measure the additive IOP-lowering effect of QLS-111 in combination with latanoprost vs. latanoprost alone in patients 12 years and older with open angle glaucoma or ocular hypertension who, upon enrollment, were currently on latanoprost. According to the company, QLS-111 is an “ATP-sensitive potassium channel modulator that is designed to reduce IOP by reducing [episcleral venous pressure] and distal outflow resistance.” The company noted that no currently approved glaucoma therapies directly address distal outflow and episcleral venous pressure, the latter of which can significantly impact IOP.

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First patient dosed in allogenic cell therapy trial

Aurion Biotech announced that it has dosed its first patient in Canada for its Phase 1/2 clinical trial evaluating allogenic cell therapy for treatment of corneal edema secondary to corneal endothelial dysfunction. According to the company’s press release, this prospective, multicenter, randomized, double-masked, parallel-arm cell dose-ranging trial is taking place in the U.S. and Canada. It will evaluate three doses of AURN001 (a biologic-drug therapy comprised of neltependocel (allogenic human corneal endothelial cells) in combination with Y-27632 (a ROCK inhibitor) in about 100 patients. The primary endpoint is percentage of patients who gain 3 lines of vision at 6 months after treatment.

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Company outlines resubmission plan for reproxalap NDA

Aldeyra Therapeutics announced its intent to resubmit an NDA to the FDA for topical reproxalap, 0.25%, for treatment of dry eye disease. According to the company’s press release, it is going to begin a dry eye chamber clinical trial this year and, with positive results, will resubmit an NDA in the second half of 2024. The FDA did not approve the initial NDA submitted by the company in 2023.

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Safety information for the upcoming solar eclipse

The National Eye Institute is providing safety information about the upcoming solar eclipse, reminding the public to never look directly at the sun, educating about the risks, and recommending safe viewing techniques for the celestial event. A total solar eclipse visible in a path across North America will take place April 8.

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Upcoming company presentations at Eyecelerator and the ASCRS Annual Meeting

Click to read company press releases with more details.

• Alcon
• Aurion Biotech
• Azura Ophthalmics
• Bausch + Lomb
• BELKIN Vision
• Centricity Vision
• Glaukos
• Johnson & Johnson Vision
• OKYO Pharma
• Sight Sciences
• STAAR Surgical
• ViaLase
• Zeiss

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Complimentary access to video journal

The latest issue of the Video Journal of Cataract, Refractive, & Glaucoma Surgery, founded and edited by Robert Osher, MD, is online now.

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ASCRS news and events

• ASCRS Annual Meeting: The ASCRS Annual Meeting begins today and runs through April 8. Keep up with activities from the meeting by following ASCRS on social media.
• EyeWorld Onsite: Keep an eye on your inbox for daily emails from EyeWorld Onsite that will provide coverage from the ASCRS Annual Meeting.

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Research highlights

• The 5-year corneal endothelial safety profiles of three MIGS devices was evaluated in a post-hoc analysis of prospective, randomized, single-masked pivotal trials that took place in the U.S. The devices included were iStent inject (Glaukos), Hydrus Microstent (Alcon), and CyPass Micro-Stent (Alcon, no longer on the market). The study, published in the Journal of Cataract & Refractive Surgery, found that a “comparable proportion of eyes” in the iStent plus phaco and control groups had “significant 60-month endothelial cell loss (ECL), 9.4% and 6.3%, respectively. Hydrus and CyPass had 27.2% and 28.7% endothelial cell loss, respectively, which the authors stated is more than their respective control groups. Mean endothelial cell density over 60 months was “indistinguishable” in the iStent group vs. control. The authors reported that no patients in the iStent or Hydrus groups developed persistent corneal edema, but 7 patients with CyPass developed endothelial cell loss-related complications.
• A retrospective cross-sectional single-center study evaluated donor characteristics that were likely to influence DMEK graft preparation outcomes. The study included 846 eyes that had DMEK surgery and that had information about donors’ previous diseases and surgeries. The authors divided preparation groups into easy, difficult, and very difficult based on stripping difficulty, rolling and staining behavior, central and peripheral adherences, fragility, and Descemet’s membrane (DM) splitting. They found that donor tissue from patients with type 2 diabetes, heart failure, previous cataract surgery, chronic kidney disease, and older age were more likely to be associated with difficult graft preparation. Moreso, the authors found that each additional year of a donor’s age increased the odds of being classified as having a “very difficult preparation” by 3%. Chronic kidney disease was associated with poor tissue staining with trypan blue. The research is published in the journal Clinical Ophthalmology.

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Product news

• RYZUMVI (phentolamine ophthalmic solution, 0.75%) by Viatris (Ocuphire Pharma) began its commercial launch in the U.S.
• Haag-Streit launched the Eyesi Indirect Ophthalmoscope ROP Simulator, a tool for training retinal examinations and classification of ROP on premature infants.

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