MacuCLEAR and Mystic Successfully Complete Phase Ib Clinical Trial for Macular Degeneration
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PLANO, Texas--(Business Wire)--
MacuCLEAR, Inc. ("MacuCLEAR") and Mystic Pharmaceuticals, Inc., ("Mystic")
announced today preliminary successful results of a Phase Ib Clinical Trial for
the treatment and prevention of the progression of Age Related Macular
Degeneration (AMD). The preliminary results indicated that MacuCLEAR`s MC-1101
drug is safe and well tolerated by study participants, and has a biological
effect on blood flow in the back of the retina. Mystic`s VersiDoser ophthalmic
delivery system was used by trial participants to self-administer MC-1101 to the
front of the eye during the trial. The study included Proof Of Concept ("POC")
indicators. A key finding of the study was the successful migration of the drug
to the back of the eye.
"We are very pleased with the groundbreaking results of this study," said Philip
G. Ralston, Jr., President and CEO of MacuCLEAR. "We have confirmed the safety
of MC-1101 in humans, a primary endpoint for the study." Ralston added, "We are
excited about the implications of the proof of concept part of this study. Using
special laser Doppler flow instrumentation, we showed MC-1101 gets to the back
of the eye and significantly modulates the blood flow in the choroid, the tiny
blood vessels in the back of the macula portion of the retina. This study
provides additional scientific evidence supporting our theory that restoring
blood flow in the choroid will have a positive affect on preventing the
progression of this terrible disease that is the leading cause of blindness for
people over the age of 50 in the world." MacuCLEAR will publish the full results
of study later this year.
Mystic Pharmaceuticals` President and CEO, Timothy Sullivan, stated, "We are
pleased to have partnered with MacuCLEAR to develop a drug/delivery system
combination that has the potential to provide a simpler, safer and ultimately
cost effective solution to the millions of people suffering from this disease."
Ralston added that, "Mystic`s delivery system provided key benefits for both
MacuCLEAR and the trial participants. Mystic`s novel unit dose approach to
packaging each eyedrop individually enabled us to use a preservative free
formulation and the control Mystic`s technology provides for calibrated
precision dose delivery and spray plume definitely enhanced absorption of the
drug to the back of the eye." Patients were able to safely and effectively
self-administer MC-1101 throughout the trial using the VersiDoser system. "An
overwhelming majority of the trial participants expressed a strong positive
preference for using the VersiDoser Delivery System over traditional eye drop
delivery," Sullivan concluded. Mystic will publish study results of trial
participant preferences for its VersiDoser Delivery System later this year.
Ralston and Sullivan presented a summary of the trial results at the Texas
Emerging Technology Fund Investment Symposium on October 8, 2009 at the
Renaissance Hotel in Richardson, Texas. MacuCLEAR and Mystic presented the
status of the progress of their companies at this symposium featuring companies
that have received investments from the State of Texas Emerging Technology Fund.
About MacuCLEAR:
MacuCLEAR, Inc. is a specialty pharmaceutical development company, based in
Plano, Texas. Its lead compound, MC-1101 is a novel, topically delivered
solution for the treatment and prevention of the progression of the Dry or early
stage of age related macular degeneration, which afflicts 90% of all who have
AMD. George C.Y. Chiou, PhD, who led the development of Timolol, a pioneering
treatment for glaucoma, invented this technology at Texas A&M University.
For more information please visit the MacuCLEAR website: www.macuclear.com
About Mystic Pharmaceuticals, Inc.
Mystic Pharmaceuticals is an integrated specialty pharmaceutical company based
in Austin, Texas. Mystic`s VersiDoser Delivery Platform provides precision unit
dose drug delivery technology for pharmaceuticals, biologic agents, vaccines and
other compounds for ophthalmic and intranasal applications. Mystic combines its
novel drug delivery systems with a pipeline of pharmaceuticals and biologics
under development by Mystic or its partners, to meet the expanding global market
demand for pharmaceuticals, biopharmaceuticals and vaccines which are lower
cost, simplified administration and provide enhanced compliance for consumers.
For more information please visit the Mystic website:
www.mysticpharmaceuticals.com
MacuCLEAR
Phillip G. Ralston, Jr., +1-214-577-5999
Pralston@macuclear.com
or
Mystic Pharmaceuticals, Inc.
Rhonda Schlueter, +1-512-918-2900 ext. 224
rschlueter@mysticpharma.com
Copyright Business Wire 2009
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