Results from investigational non-incisional glaucoma treatment

ViaLase announced results from its 12-month, prospective, single-center, non-randomized FLigHT (femtosecond laser image-guided high-precision trabeculotomy) study, which was a first-in-human study of the company’s investigational femtosecond laser for non-invasive trabeculotomy. According to the company’s press release, nine patients (15 eyes) with open-angle glaucoma or ocular hypertension received the non-incisional trabeculotomy with the ViaLase laser after medication washout. There were no adverse treatment-related events, and the treatment achieved a reduction in mean IOP at 12 months. The investigators reported that no eyes required IOP-lowering medication after 1 year, and there was no evidence of scarring viewed on gonioscopy. According to the company, a multicenter, randomized trial is underway to validate the results of this first-in-human trial.

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Study: preservative-free latanoprost efficacy similar to preserved alternative

Thea Pharma announced Phase 3 data on preservative-free IYUZEH (latanoprost ophthalmic solution) 0.005% for IOP lowering in patients with primary open-angle glaucoma or ocular hypertension. The study compared IYUZEH to Xalatan (latanoprost ophthalmic solution, Pfizer) 0.005%, which is preserved with BAK, in 334 patients over 84 days. According to the company’s press release, IYUZEH achieved similar IOP lowering from baseline with fewer adverse ocular events (13.9% vs. 22.5%). The company reported less than 2% of patients who received IYUZEH experienced pain upon instillation, pruritis, or conjunctival hyperemia. Thea received FDA approval for IYUZEH in December 2022 and will launch in the U.S. later this year. The drop has been marketed and used outside the U.S. as MONOPROST for a decade.

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FDA accepts priority review NDA for vitreoretinal lymphoma treatment

Aldeyra Therapeutics announced FDA acceptance and priority review of its NDA for ADX-2191 (methotrexate injection) for treatment of primary vitreoretinal lymphoma. According to the company’s press release, the NDA is based on decades of methotrexate safety/efficacy data as well as a Phase 3 trial of ADX-2191 in patients with proliferative vitreoretinopathy. A PDUFA date is set for June 21. If approved, the company plans to launch ADX-2191 in the second half of this year.

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Companies partner to develop dry eye drop

Grifols, a company developing plasma-derived medicines, entered into an agreement with Selagine, a company developing therapeutics for ocular diseases, to develop immunoglobulin eye drops for the treatment of dry eye. According to the company’s press release, a pilot Phase 1/2 study was conducted with patients treated twice daily for 8 weeks. The study showed “a significant reduction in the signs and symptoms of [dry eye disease], and with no difference in tolerability or adverse events,” the company reported.

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Company announces lead asset in its agonist antibody pipeline

EyeBio announced the first and lead asset in its agonist antibody pipeline for retinal diseases. According to the company’s press release, Restoret is a tri-specific Wnt agonist antibody. The Wnt pathway, which the company reported has been studied for decades, includes genes for proteins that drive development and maintenance of the blood-retinal barrier. Wnt signaling in the retina, the press release continued, maintains vascular integrity, and any issues with Wnt signaling can cause vascular leakage. Restoret is designed to restore the natural Wnt ligand in the eye. The company stated that it will file for Phase 1b/2 clinical trial authorization in the second quarter of 2023.

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ASCRS news and events

• ASCRS Annual Meeting: Registration for the ASCRS Annual Meeting, May 5–8, 2023, in San Diego, California, is ongoing. “Make Waves” in education, innovation, and networking specifically focused on anterior segment surgery. The Tier 2 registration deadline is March 29.
• ASCRS Annual Meeting Preview Program: The ASCRS Annual Meeting Preview Program is available online with details about Annual Meeting schedules and programming.
• Eyecelerator: Registration is open for Eyecelerator @ ASCRS 2023. The innovation conference from ASCRS and the American Academy of Ophthalmology will be held on May 4 in San Diego, California. Join investors, industry leaders, and ophthalmologists at this showcase of companies, technology, and other exciting innovation topics in ophthalmology.

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Research highlights

• A multicenter, retrospective case series compared the accuracy of several IOL formulas in patients with keratoconus. The study included data from 57 eyes with stable keratoconus from the Shaare Zedek Medical Center in Jerusalem, Israel, and the University Eye Clinic in Maastricht, the Netherlands. The study evaluated prediction accuracy of the Barrett True-K, SRK-T, Barrett Universal II, Kane, and the Kane keratoconus formulas. The study found that prediction error was not significantly different from zero with the SRK/T, Barrett True-K, and Kane keratoconus formulas. The absolute error of the Barrett True-K (predicted) and the Barrett True-K (measured) were significantly lower than the Barrett Universal II and Kane formulas. The authors concluded that the “Barrett True-K formulas for keratoconus had higher prediction accuracy compared to newer generation formulas and similar prediction accuracy compared with Kane keratoconus formula.” The study is published in the Journal of Cataract & Refractive Surgery.
• Five-year postop safety data with iStent inject (Glaukos) was published in the American Journal of Ophthalmology. The data included stability, endothelial cell density, and endothelial cell loss. All iStent inject procedures were performed in combination with cataract surgery. The study included 227 patients with mild to moderate POAG, 178 who received iStent inject with phaco and 49 who received phaco alone. According to the authors, there were no significant differences between the two groups in mean endothelial cell density, mean percentage change in endothelial cell density, or the proportion of eyes with more than 30% endothelial cell loss. The mean percentage decrease in endothelial cell density at 5 years was 14.3±13.4% in the iStent inject group and 14.8±10.3% in the phaco alone group.

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Product news

The ELITA Femtosecond Laser System (Johnson & Johnson Vision) received the CE Mark.

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