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Laser-assisted Non Penetrating Deep Sclerectomy
Laser-assisted NPDS utilizes a CO2 laser to thin the scleral tissue around Schlemm's Canal without penetrating the scleral wall, thereby reducing IOP by facilitating adequate, functional percolation of intra-ocular fluid from the eye through the remaining membrane. Percolation is achieved without penetrating the eye globe, thus reducing the likelihood of complications commonly experienced with the current gold standard glaucoma treatment, i.e. trabeculectomy, which involves full thickness penetration.
IOPtima aims to achieve the effectiveness of traditional NPDS while minimizing the risk of perforating the remaining membrane via the use of the IOPtiMate™ CO2 laser-assisted NPDS system. Using the IOPtiMate™ in conjunction with the CO2 laser allows for a self-regulating procedure where ablation ceases once the desired scleral thickness has been achieved. This elegant self-regulated surgical approach is possible because CO2 laser energy dissipates in water or aqueous solutions, thus inhibiting the ablation of scleral tissue as soon as it comes in contact with sufficient intra-ocular percolating fluid. As an all-inclusive platform for laser-assisted NPDS, the IOPtiMate™ is designed to achieve functional, simple, safe, reproducible and optimal results with minimal complications. The IOPtiMate™ is expected to make NPDS surgery attractive to eye surgeons in a safe, fast and cost effective manner. Regulatory processes are underway.
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Schematic presentation of Laser-Assisted NPDS:
The scanning laser beam safely and accurately ablates thin sclera layers until the desired percolation is attained via the intact tissue. The percolation automatically prevents further ablation even if the lasing continues. |
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Advantages of IOPtima's Non-Penetrating Laser Assisted NPDS:
- Self-regulating, accurate ablation
- Minimal learning curve
- Out-patient procedure
- Potential solution for noncompliant patients and those without access to drug therapy
- Cost effective in reducing expenses of chronic drug therapy
- Intended to penetrate glaucoma clinics as well as all cataract clinics
- Add-on to any contemporary ophthalmic microscope
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Market
Glaucoma is a chronic disease that requires life-long therapy and affects an estimated 67 million people globally, including more than 5 million in the United States and 12 million in Europe. The primary risk factor for glaucoma is elevated IOP, typically in excess of 20 mmHg. Over $4.1 billion is spent annually on pharmaceutical therapies that, in many cases, have limited long term efficacy, produce significant complications, can be prohibitively expensive, and have low patient compliance. Despite the longer-term efficacy of some surgical solutions, these alternatives are historically considered only after medical therapy fails, due to the significant risks associated with many of these procedures. However, due both to lengthening life-spans and because recent evidence suggests that early surgical intervention is sometimes more effective than surgery performed after many years of drug therapy, the $100+ million surgical device market is expected to grow at almost 13% per year, well above the glaucoma incidence rate. The availability of a safe and efficacious surgical procedure could even more significantly increase the number of surgical interventions.
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