LASER induced Hyperthermia for Glaucoma

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“Research Innovation for Glaucoma” Support for LASER induced Hyperthermia trial for Glaucoma

A US-based device company has developed novel laser treatment that seeks to accomplish these early interventions in an extremely safe and repeatable as-needed manner. The novel laser-based treatment of glaucoma, a leading cause of irreversible blindness worldwide, aims to achieve two therapeutic goals: reduction of intraocular pressure (IOP) by transscleral perilimbal hyperthermia and neuroprotection to prevent or slow glaucoma’s neurodegenerative progression by transpupillary pan macular hyperthermia.

The company engaged Nextvel to provide support for the clinical investigation of LASER-induced hyperthermia for glaucoma treatment. The engagement began with ex vivo experiments using cadaveric animal eyes to test the safety and physiological effect of the LASER on the tissue before conducting a feasibility first-in-human safety study.

Nextvel designed the trial in consultation with the company, as a prospective study to evaluate the safety and efficacy of the device for the treatment of primary glaucoma in Indian adults. The trial was conducted in India, in patients with low visual potential having glaucoma. 13 patients underwent unilateral LASER therapy. Follow-up assessments were performed at Month 1 and 3.

The study reported mild, reversible adverse effects that resolved fully during the study duration. Remarkably, the IOP-lowering effect of the LASER was found to be statistically significant at 3 months. Based on these promising results, the sponsor is optimizing the device design and preparing for the next phase of clinical testing.

This innovative approach to glaucoma treatment has the potential to preserve patients’ best possible visual function and disease-related quality of life, offering hope to millions of individuals affected by this debilitating condition.