BUSINESS WIRE
RAMAT GAN, Israel--(BUSINESS WIRE)--IOPtima, a subsidiary of Bio-Light Life Science Investments (TASE:BOLT),
announced today that it has successfully completed the 3 month follow-up
period for an initial human clinical study using the company’s
OT134 device and procedure. The novel, laser-based therapy enables eye
surgeons to operate and reduce internal eye pressure without penetrating
the eye membrane.
“The absence of any safety issues during the
study and the impressive reduction in intra-ocular pressure suggest that
our non-penetrating technology could revolutionize the way glaucoma is
treated,” said Dr. Joshua Degani, CEO of
IOPtima.
“The study suggests that IOPtima’s
laser filtration system may offer significant efficacy and safety
advantages, as well as reduces the potential risks, side effects and
complications, over current surgical procedures. In addition our system
may present an alternative to current drug therapies, many of which
involve heavy medication regimens with poor patient compliance,”
said Dr. Ami Eyal, CEO of Bio-Light.
In the course of the study 13 patients were treated at a leading
glaucoma center in Mexico City, under the supervision of Professor Felix
Gil Carrasco, a prominent eye surgeon.
IOPtima intends to further monitor the patients for at least one year.
The study is the first leg in a multi-national clinical trial at leading
ophthalmology centers around the world aimed at obtaining regulatory
approval for Europe.
In addition, IOPtima plans to meet with the FDA in the near future in
order to initiate procedures aimed at US regulatory approval.
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,
very time consuming 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 aim is to achieve the effect of NPDS
while removing the risk of perforating the membrane and minimizing the
risk of perforating the scleral tissue via its CO2
laser-based system which 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. 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 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.