Business Wire
IOPtima announced today that it has completed development of its
OT134 device, a novel laser-based therapy for the treatment of
glaucoma. The second-generation OT134 is based on IOPtima's smart
laser-based technology known as LNPDS (CO2 Laser Non-Penetrating Deep
Sclerectomy) that has already been successfully tested on 23 glaucoma
patients in clinical trials. The OT134 upgrades the previous prototype
with improved efficacy and ergonomic features.
"Our innovative laser-based technology for the first time provides
eye surgeons with an easy-to-use and safe method for treating glaucoma
that is likely to be adopted by a large number of eye surgeons," said
Dr. Joshua Degani, CEO of IOPtima.
"IOPtima's laser filtration system offers significant efficacy and
safety advantages, as well as the risk of far fewer complications,
over traditional drug and surgery therapies for glaucoma," said Prof.
Ehud Assia, M.D., Director of the Dept. of Opthalmology at Meir
Hospital, Israel and IOPtima's Chief Scientist.
IOPtima plans to begin later this year a multinational long-term
human clinical trial testing the OT134's efficacy at leading
ophthalmology centers around the world.
About IOPtima's Technology
The most efficient currently-used surgical approach is known as
Trabeculectomy. Non-Penetrating Deep Sclerectomy surgery is a similar
but modified procedure causing a significantly smaller number of side
effects. Both technologies reduce intraocular pressure, the key cause
of glaucoma, by removing scleral tissue in a small flap of the eye.
Whereas in conventional trabeculectomy, the surgeon penetrates through
the wall of the eye, in the NPDS procedure, the surgeon only
penetrates to approximately 95% of the scleral depth while leaving a
residual intact thin layer of several dozen microns. Doing so without
inadvertently perforating the thin trabecular membrane is at present
very demanding and requires great skill and vast experience.
Consequently only a small number of eye surgeons are able to perform
this procedure, and the potential benefits of the non-penetrating
surgical approach are not widely available to glaucoma patients.
IOPtima's unique approach removes the risk of perforating the
membrane and minimizes the risk of perforating the scleral tissue
because its CO2 laser-based system is self-terminating once the
desired scleral thickness has been achieved. This elegant
self-regulation is possible because the CO2 laser essentially stops
ablating as soon as it comes in contact with the intra-ocular
percolated liquid, which is what occurs as soon as the laser reaches
the optimal residual intact layer thickness.
The OT134 is expected to make non-penetrating deep sclerectomy
surgery accessible to all eye surgeons in a safe, fast and cost
effective manner.
The Market
It is estimated that nearly 67 million people worldwide suffer
from glaucoma. Glaucoma is a chronic disease that requires life-long
therapy. Medication treatments, amounting to $2-3 billion spent
globally each year, often fail because of low patient compliance and
because in many cases it has limited long term efficacy. Early
surgical intervention is sometimes more effective than surgery
performed after many years of drug therapy.
In the United States, glaucoma is the second leading cause of
blindness. It is estimated that up to 3 million Americans, aged 40 and
over, have glaucoma and 15 million more are at risk for vision loss
from glaucoma. Today, about 500,000 surgical procedures are performed
annually in the USA alone: 125,000 trabeculectomies, 250,000-300,000
trabeculoplasties, and 75,000-125,000 other surgical procedures,
representing a total expenditure of approximately $750 million.
The availability of a safe surgical procedure can be expected to
significantly increase the number of surgical interventions.
About IOPtima
IOPtima Ltd. (formerly Optotech) focuses on the discovery,
development and commercialization of innovative and proprietary
technologies for the treatment of glaucoma -- a common eye disease
that leads to loss of sight. The company has developed an innovative
non-penetrating, easy-to-use system, based on CO2 laser technology,
for the treatment of glaucoma. IOPtima has completed successful human
clinical trials on 23 subjects with its first generation device.
IOPtima believes that its innovative new OT134 system will offer
significant advantages over traditional therapies for glaucoma, such
as simplicity, higher efficacy, lower risks to the patient, fewer side
effects and lower costs. The availability of a safe surgical procedure
is expected to increase the number of surgical interventions.
IOPtima holds a U.S. patent on the basic concept of the technology
that it has developed for the treatment of glaucoma, and has filed
requests for patent registration in additional countries.
IOPtima is a subsidiary of Bio-Light Life Science Investments, a
management and holding company specializing in biomedical
technologies. Bio-Light is traded on the Tel Aviv Stock Exchange under
the symbol (TASE:BOLT).