ViaLase Gets CE Mark for First Glaucoma Femtosecond Laser

ViaLase, Inc., a company specializing in medical technologies for glaucoma treatment, has announced the approval of its ViaLase Laser in the European Union. The ViaLase Laser, which has earned the CE Mark, is designed to treat adult patients suffering from primary open-angle glaucoma (POAG). This laser represents a breakthrough in glaucoma care by combining femtosecond laser technology with highly precise image guidance to perform a procedure known as femtosecond laser, image-guided, high-precision trabeculotomy (FLigHT). This noninvasive treatment option aims to cater to a significant patient need for an incision-free, non-pharmacologic alternative without compromising the effectiveness of the therapy.

ViaLase plans to introduce the ViaLase Laser selectively in key European markets later this year. According to Tibor Juhasz, Ph.D., Founder and CEO of ViaLase, Inc., the ViaLase Laser is poised to revolutionize glaucoma treatment by offering surgery-like outcomes without the necessity to open the eye, thereby reducing the risk of complications typically associated with more invasive surgical procedures. Preliminary clinical data suggest that FLigHT is both safe and effective in lowering intraocular pressure (IOP), which is crucial for managing glaucoma.

Dr. Richard Lewis, Chief Medical Officer at ViaLase, expressed optimism about the benefits of early, non-medical interventions. He emphasized that the ViaLase Laser introduces a new level of imaging and precision, offering better long-term disease control and vision preservation for patients. Importantly, the patient's lens status does not affect their eligibility for FLigHT, thus broadening treatment access to more patients who previously had limited options.

To facilitate the commercial rollout, ViaLase has established strategic distribution partnerships with Global Surgical Service for Spain and Portugal, and Teleon Surgical for Germany and Austria. Both organizations have substantial experience in ophthalmology and possess a strong commercial presence in their respective markets. These partnerships are expected to ensure a timely and efficient introduction of the ViaLase Laser to both physicians and patients.

Glaucoma, a condition that affects 76 million people worldwide and is projected to impact 112 million by 2040, is the second leading cause of irreversible blindness globally. The disease often progresses silently, leading to a gradual loss of vision. Early detection and intervention are crucial for preventing irreversible vision loss. Current treatment protocols typically start with topical eye drops and may escalate to laser therapy or minimally invasive glaucoma surgery (MIGS). In more severe cases, traditional invasive filtration surgery may be necessary. The ViaLase Laser aims to disrupt this conventional treatment paradigm by providing a noninvasive, image-guided alternative that effectively lowers IOP and reduces the progression of visual field loss.

ViaLase, Inc., based in Aliso Viejo, California, is a clinical-stage company with a focus on developing noninvasive glaucoma treatments. The company is backed by venture capital and boasts a leadership team with extensive experience in designing, manufacturing, and commercializing femtosecond lasers for ophthalmic surgery. ViaLase is committed to collaborating with healthcare providers, payers, societies, and patients to refine its products and commercial strategies, aiming to bring this innovative treatment to glaucoma patients worldwide.

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