Iridex MicroPulse TLT shows sustained IOP cuts in two-year study

An independent Italian study found MicroPulse transscleral laser therapy reduced intraocular pressure by 37% over 24 months across early to advanced glaucoma.

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A brightly lit modern ophthalmology examination room features a white autorefractor in the foreground, with large windows, overhead surgical lights, and a wooden counter with potted plants in the background.

Iridex Corporation has announced the publication of a two-year retrospective study supporting the sustained efficacy of its MicroPulse transscleral laser therapy (TLT) in patients with primary open-angle glaucoma and primary angle-closure glaucoma. The study, led by Michele Lanza of the Università della Campania Luigi Vanvitelli in Naples, appeared in the International Journal of Ophthalmology and was conducted independently of Iridex.

The trial evaluated 84 eyes in 53 patients and excluded anyone with prior incisional glaucoma surgery, though patients who had received selective laser trabeculoplasty more than three years earlier were eligible. The Iridex Cyclo G6 laser with the MicroPulse P3 delivery device was used throughout.

Key results

At 24 months, mean intraocular pressure fell from 22.32 mmHg at baseline to 14.05 mmHg, a reduction of roughly 37%. The mean number of topical IOP-lowering medications dropped from 2.96 to 2.38. Treatment success rates were 86% in the open-angle group and 81% in the angle-closure group. The study also found that all patients who had been taking oral acetazolamide before treatment were able to discontinue it, with none requiring reinitiation over the full follow-up period. No complications or losses in visual acuity were reported, and visual field measurements remained stable in both groups.

Lead author Lanza said the two-year data were "particularly meaningful" because they demonstrated sustained IOP reduction and reduced medication burden across the full severity spectrum, and suggested that MicroPulse TLT "may have a role earlier in the glaucoma treatment continuum than has traditionally been considered." Patrick Mercer, president and chief executive of Iridex, said the findings reinforced the company's commitment to laser-based treatment options for glaucoma patients.

Market context

Glaucoma affects an estimated 80 million people worldwide and is a leading cause of irreversible blindness. The treatment market is highly competitive, spanning topical prostaglandin analogues and beta-blockers, minimally invasive glaucoma surgeries (MIGS), selective laser trabeculoplasty, and more invasive filtering procedures such as trabeculectomy. Laser-based and device-led approaches have gained traction over the past decade as clinicians seek options that reduce patients' dependence on long-term topical medication regimens, which carry adherence challenges and cumulative ocular surface side effects.

MicroPulse TLT sits in a niche between pharmacological management and surgical intervention, and the suggestion from this study that it could be introduced earlier in the disease course is commercially significant for Iridex. Several competing cyclophotocoagulation and MIGS platforms are also seeking to move upstream in the treatment algorithm. The retrospective design of this study is a limitation; a prospective, randomised trial comparing MicroPulse TLT with standard-of-care first-line therapy would carry substantially more regulatory and clinical weight. Iridex has not announced any such trial, and investors will be watching for evidence that the company intends to pursue one to substantiate the early-intervention positioning suggested by this dataset.

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