The treatment of glaucoma, the second leading cause of blindness in the world, has the hallmark of a clinical field that's somewhat early in its development. There is no clinical consensus regarding preferred therapies, and potential treatments are few and very different from one another. Current glaucoma therapies range from drugs offering maximum safety and minimal efficacy to surgical procedures offering great efficacy but also great risks.
In Glaucoma, Devices Go Eye-to-Eye with Drugs
Glaucoma is of serious interest to VCs and strategic investors because of its sheer size; the disease affects 3 million people, most of them managed by drugs. Glaucoma drugs have created a $4 billion market, but have several problems, the greatest of which is non-compliance. Glaukos and other device companies aim to introduce devices that are safe and efficacious enough to compete directly with drugs, rather than standing in as an alternative to today's glaucoma surgeries reserved for end-stage patients. Glaukos recently marked a first of its kind victory; with a tiny implantable ophthalmic stent, Glaukos emerged from a PMA clinical trial that convinced an FDA panel of the benefit-to-risk ratio of its approach when used as a first-line therapy in a select group.
More from Archive
• By
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
• By
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.
• By
Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
• By
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
More from Medtech Insight
• By
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.
• By
Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.
• By
FDA Commissioner Marty Makary stated in a new interview that there will be no significant reorganization of the agency, despite earlier reports. Using his “guiding principles” of common sense and gold-standard science, he plans to focus on reforms including improved pathways for medical AI and food safety as well as addressing employee morale.