developer of innovative therapeutics for the treatment of severe ocular
diseases and conditions, announced positive interim data from a Phase
1 study of its lead product candidate in patients with chronic, clinically
significant diabetic macular edema (DME). Results from this prospective
study of 50 patients demonstrated that MacuSight's proprietary formulation
of sirolimus (rapamycin) was safe and well-tolerated in all doses tested
with two different routes of administration. Additionally investigators
noted improvements in visual acuity and foveal thickness reductions for up
to 180 days following a single administration of sirolimus. These findings
were presented at the 40th Annual Meeting of The Retina Society by Mark
Blumenkranz, M.D., chairman of MacuSight's scientific advisory board and
professor and chairman of the department of ophthalmology, Stanford
University School of Medicine.
As part of the design of this randomized, open-label study,
investigators evaluated the safety, tolerability and biological activity of
sirolimus when delivered by either subconjunctival or intravitreal
injection. Intravitreal injections (into the central cavity of the eye),
while the standard route of administration for current therapies, are
uncomfortable for many patients and are accompanied by the risk of serious
infection in a small percentage of patients. In contrast, subconjunctival
injections (just under the outer layer over the white of the eye) are
designed to offer physicians and patients a less invasive and more
convenient procedure. MacuSight's DME trial included ten treatment arms
with patients receiving one of five doses of sirolimus via either a single
subconjunctival injection or a single intravitreal injection. Preclinical
studies suggested that a single administration may provide the patient with
exposure to sirolimus for up to approximately three months.
In addition to safety and tolerability data, the study provided an
initial assessment of sirolimus' biological activity in DME. At 45 and 90
days following treatment, patients receiving the two lowest doses of
sirolimus by subconjunctival injection demonstrated mean improvements in
visual acuity of 8.5 and 7.4 letters over baseline, respectively, using a
standard (ETDRS) eye chart. Additionally, this group of patients also
experienced anatomical improvements, with a mean decrease in foveal
thickness that was consistent with the observed functional improvements in
visual acuity. Preliminary data for these patients at 180 days following
treatment suggest that these initial improvements in visual acuity and
foveal thickness reductions were maintained, or even enhanced, over time in
many patients.
"The fact that we are seeing measures of biological activity
maintained, and, in some cases improving, through 180 days following a
single subconjunctival injection, is somewhat surprising. This finding
raises the possibility that sirolimus may be fundamentally changing the
course of diabetic retinopathy through its impact on the mTOR (mammalian
target of rapamycin) pathway rather than simply reversing macular edema in
a more non-specific way," said Dr. Blumenkranz. "Further studies to support
or refute this hypothesis will be necessary. However, if so, then the
potential clinical utilization of the drug may eventually extend beyond
those patients with clinically significant diabetic macular edema."
"The study's findings are intriguing, particularly in light of the fact
that a majority of the participants had been previously treated for DME. As
such, these results provide great excitement for researchers as we prepare
to advance this product into Phase 2 clinical studies," stated David A.
Weber, Ph.D., president and chief executive officer of MacuSight. "We are
also delighted the drug appeared so effective by a simple subconjunctival
injection, a route of administration that is able to decrease the risk and
treatment burden to patients and physicians alike. As a result, we can
confidently proceed with our clinical development of sirolimus as a product
delivered via subconjunctival injection."
With regard to safety and tolerability, the study showed no evidence of
increased intraocular pressure or inflammatory response to treatment.
MacuSight intends to complete its collection and analysis of all data from
this trial and present final findings later this year.
"From a patient treatment standpoint, the study findings related to the
safety and biological activity of sirolimus administered through
subconjunctival injection are very exciting," stated Pravin U. Dugel, M.D.,
clinical instructor, vitreoretinal diseases and surgery, department of
ophthalmology, University of Arizona, partner at Retinal Consultants of
Arizona in Phoenix, Arizona, and the study's lead investigator. "By
offering both physicians and patients significant benefits in the way of
reduced invasiveness, safety and ease of administration, the
subconjunctival injection has the potential to dramatically improve the
current DME treatment paradigm."
Additionally, MacuSight has completed enrollment of its second Phase 1
trial which is examining its same proprietary sirolimus formulation in
patients with exudative age-related macular degeneration. Results from this
second trial are expected to be presented during the first half of 2008.
About Sirolimus
Sirolimus, originally known as rapamycin, is a highly-potent,
broad-acting compound that has demonstrated the ability to combat disease
through multiple mechanisms of action including immunosuppressive,
anti-angiogenic, anti-migratory, anti-proliferative, anti-fibrotic and
anti-permeability activity. Based on the versatility associated with these
multiple mechanisms of action, MacuSight believes that its sirolimus
product may serve as a potentially highly-efficacious therapeutic for a
wide range of ocular diseases and conditions, including the treatment and
prevention of wet AMD.
As the active pharmaceutical ingredient in the FDA-approved products
Rapamune(R) and CYPHER(R) Sirolimus-eluting Coronary Stent, sirolimus has
been safely administered to humans for more than six years. MacuSight has
developed a proprietary minimally-invasive, sustained administration
approach for its novel liquid sirolimus formulation which it believes will
provide the product with significant competitive advantages related to
convenience, ease-of-use, compliance and safety.
About Diabetic Macular Edema
Diabetic macular edema (DME) is a serious manifestation of diabetic
retinopathy that involves retinal swelling brought on by the leaking of
fluid from small blood vessels within the macula. As the condition
develops, central vision becomes blurred. DME can progress fairly rapidly
and over just a few years can lead to permanent visual loss. There is a
significant unmet need to both reverse the visual loss associated with DME
and to help delay the progression of this condition.
About MacuSight
MacuSight is a privately-held pharmaceutical company focused on
developing innovative therapeutics for the treatment of severe ocular
diseases and conditions. The company is dedicated to preserving patients'
vision by identifying known, highly-potent and broad-acting small molecule
drug compounds that may possess efficacy in treating and/or preventing
diseases or conditions of the eye. As part of its unique product
development philosophy, MacuSight also concentrates on the optimal delivery
of these compounds into the eye. By combining its compounds with innovative
delivery approaches, the company strives to optimize the efficacy, safety,
convenience and cost- effectiveness of its product candidates.
The company's lead development program is centered on advancing
sirolimus (rapamycin) as a potential next-generation therapeutic for the
treatment and prevention of wet age-related macular degeneration (wet AMD)
and the treatment of diabetic macular edema (DME), a manifestation of
diabetic retinopathy.
MacuSight, Inc.
macusight
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