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Postdoctoral fellow Samirkumar Patel displays a prototype microneedle used to inject therapeutics into specific locations in the eye. The technology could allow doctors to target drugs to locations in the eye that are now difficult to reach. Photo: Gary Meek
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Technology developed by researchers at the Georgia Institute of Technology
and Emory University for delivering drugs and
other therapeutics to specific locations in the eye provides the foundation for
a startup company that has received a $4 million venture capital investment.
The Atlanta-based startup, Clearside Biomedical, plans to develop
microinjection technology that will use hollow microneedles to precisely target
therapeutics within the eye. If the technique proves successful in clinical
trials and wins regulatory approval, it could provide an improved method for
treating diseases that affect the back of the eye, including age-related
macular degeneration.
The technology was developed in collaboration between the research groups of
Mark Prausnitz, a Regents' professor in Georgia Tech's School of Chemical
and Biomolecular Engineering, and Henry Edelhauser, a professor in the
Department of Ophthalmology at Emory School of Medicine. Research leading to
development of the technology was sponsored by the National Institutes of
Health (NIH).
"We expect that targeting drug delivery within the eye will be helpful
because we should be able to concentrate drugs at the disease sites where they
need to act, and keep them away from other locations," said Prausnitz.
"This could reduce side effects and possibly also decrease the dose
required."
Prior to this development, drugs could be delivered to the retinal tissues
at the back of the eye in three indirect ways: (1) injection by hypodermic
needle into the eye's vitreous humor, the gelatinous material that fills the
eyeball, (2) eye drops, which are limited in their ability to reach the back of
the eye, and (3) pills taken by mouth that expose the whole body to the drug.
The technology developed by Georgia Tech and Emory uses a hollow
micron-scale needle to inject therapeutics into the suprachoroidal space
located between the outer surface of the eye—known as the sclera—and the
choroid—a deeper layer that provides nutrients to the rest of the eye. Preclinical
research has demonstrated that fluid can flow between the two layers, where it
can spread out to the entire eye, including structures such as the retina that
are now difficult to reach.
By targeting this suprachoroidal space using microscopic needles, the
researchers believe they can reduce trauma to the eye, make drugs more
effective, and reduce complications. The new delivery method could help advance
a new series of drugs being developed to target the retina, choroid, and other
structures in the back of the eye.
"This is a significant advance in the field of ophthalmology,"
said Edelhauser. "Until now, it has been difficult to target drug delivery
to specific locations within the eye. This new microneedle technology enables
precise drug targeting to the suprachoroidal space and other locations within
the eye."
In research reported in Pharmaceutical Research, the Georgia
Tech-Emory team demonstrated for the first time that this technique can be used
to deliver nanoparticles and microparticles to specific parts of the eye. In
later research, they also showed that microneedle injections into the
suprachoroidal space rapidly resulted in concentrations of drugs and particles
that could be maintained for several months.
Between two and three million eye injections are made each year, many of
them to treat age-related macular degeneration (AMD). The researchers believe
that the microneedle-based technique could be useful for treating both AMD and
glaucoma, as well as other ocular conditions related to diabetes.
The $4 million in funding for Clearside Biomedical will come from Hatteras
Venture Partners, a venture capital firm based in Research Triangle Park, N.C.
Hatteras focuses on seed and early-stage investments in companies developing
products in biopharmaceutical, medical device, diagnostic, and related human
health areas.
"Clearside Biomedical represents an ideal fit for Hatteras Discovery as
the platform technology is highly innovative, based on elegant science and the
lead product is expected to be in clinical trials in the United States
in less than 18 months," said Christy Shaffer, PhD, venture partner and
managing director of the Hatteras Discovery Fund.
So far, the technique has been tested only in animals. The Hatteras funding
will allow the company to conduct additional efficacy and safety testing needed
to seek regulatory approval. The company's first product is expected to address
macular edema and retinal vein occlusion.
Clearside was formed with the assistance of Georgia Tech's VentureLab
program, which helped obtain early-stage seed funding from the Georgia Research
Alliance. Georgia Tech VentureLab also helped the founders connect with the
company's president and CEO, Daniel White, a veteran ophthalmic entrepreneur.
Before joining Clearside, White was a co-founder of Alimera Sciences, an Atlanta company that is
developing ophthalmic pharmaceuticals.
Two researchers from the Prausnitz lab who have been involved in development
of the ocular drug delivery technique will also join the company. They are
Samirkumar Patel, a postdoctoral researcher and Vladimir Zarnitsyn, a research
scientist.
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