BUSINESS WIRE
RAMAT GAN, Israel--(BUSINESS WIRE)--IOPtima, a subsidiary of Bio-Light (TASE:BOLT), the developer of an
innovative laser-based surgical device for reducing intra ocular
pressure (IOP) for the treatment of glaucoma, successfully completed and
analyzed the results of its first 12-month follow-up period of human
clinical trials conducted in Mexico and India.
IOPtima's novel, laser-based technology enables eye surgeons to perform
a simple and safe surgery and reduce IOP without penetrating the eye
membrane. Elevated internal eye pressure, ("IOP"), is a key cause / risk
factor of glaucoma, which in many cases causes the deterioration in the
visual field and ultimately can lead to blindness. The procedure,
utilizing IOPtima technology, after 12 months follow-up, demonstrated to
be both safe and efficacious as a means to reduce IOP.
"The long-term maintenance of the IOP reduction, compiled with the high
safety profile, as demonstrated in our clinical studies, place IOPtima's
system for Glaucoma treatment in the first line of accepted Glaucoma
treatments" said Dr. Joshua Degani, CEO of IOPtima.
Study results show compelling findings for all the main criteria:
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The combined results of the study in Mexico and India demonstrated an
average reduction of 43% in IOP from 25.5 mmHg' pre procedure to 14.6
mmHg' after 12 months follow-up.
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In addition, the Company's procedure reduced the number of medications
taken by the treated patients from 2.6 medications to 0.6, on average.
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These results reflect a Qualified success, (i.e. IOP of less than 18
mmHg', regardless of medication) of 95% of those treated in the study,
and Complete success, (i.e. IOP of less then 18 mmHg' with no
additional medications), of 67%.
12-month follow-up results are considered reflective of long-term
success in IOP reduction, and indicative maintaining of lower IOP for
extended periods.
About IOPtima's Technology
IOPtima's technology utilizing a CO2 laser-based system to ablate the
scleral membrane to a thinness which will enable the percolation of the
intra ocular fluid, without penetrating the inner eye. The use of
the CO2 laser 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 IOPtima System is expected to make such non-penetrating 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. focuses on the 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 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 and applications for
additional patents. IOPtima is in advanced stages towards obtaining CE
regulatory approval and has begun a process toward FDA approval as well.
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.