BUSINESS WIRE
WEST CONSHOHOCKEN, Pa.--(BUSINESS WIRE)--Othera Pharmaceuticals, Inc., a specialty pharmaceutical company focused
on treatments for ophthalmic diseases, today announced positive visual
function results from a Phase I/II trial of OT-551 conducted at the
National Eye Institute (NEI) of the National Institutes of Health (NIH)
in patients with bilateral geographic atrophy, an advanced form of dry
age-related macular degeneration (dry AMD). Results of this study will
be the subject of a poster presentation as part of the “Late Breaking
Posters” section at the Association for Research in Vision and
Ophthalmology (ARVO) 2010 Annual Meeting, to be held May 2 – 6 in Fort
Lauderdale, Florida. A second poster will also present incomplete
results from the OMEGA Phase II trial of OT-551, which enrolled a
different patient population and employed a different dosing regimen
than the NEI study.
“We are very encouraged by OT-551’s
potential to preserve visual function in these patients with late-stage
dry AMD. The results of this study support OT-551’s potential as a
treatment for ocular diseases such as AMD where oxidative stress and
inflammation are involved.”
OT-551 is a topically-dosed, small molecule that acts on oxidative
stress and disease-induced inflammation, most likely through activation
of the transcription element Nuclear factor erythroid 2-related factor
(Nrf2). Scientific publications from leading researchers in
ophthalmology have linked decreased Nrf2 function, oxidative stress and
inflammation to the progression of dry AMD. OT-551 has demonstrated a
dose-dependent protective effect on photoreceptor activity in an animal
model of AMD, and has been shown to reach the back of the eye after
topical dosing in multiple species. In the NEI’s Phase I/II trial, 10
subjects with advanced dry AMD in both eyes were enrolled. All subjects
received 0.45% OT-551 daily for 24 months in one eye, which was randomly
chosen. The untreated fellow eye served as a control in the study. A
statistically significant (p = .0295) difference in favor of OT-551 was
observed in the primary endpoint, mean change in best-corrected visual
acuity (BCVA) at the end of 24 months (mean change in BCVA for dosed eye
of 0.2±13.3 letters gained vs. 11.3±7.6 letters lost for fellow eye
control). No other meaningful differences between study eyes and fellow
eyes were observed in other endpoints. In the NEI trial and in all
studies of OT-551 to date, there have been no drug-related serious
adverse events.
“OT-551 is a well-tolerated, topical agent with no apparent serious
adverse effects. Efficacy measurements indicate a possible effect in
maintaining visual acuity in treated eyes. However, the absence of
significant effect on the rate of GA lesion enlargement indicates the
need for further study concerning the efficacy of OT-551 as a treatment
for GA”, commented Wai T. Wong, M.D., Ph.D., a Clinician-Scientist,
Retinal Diseases at the NEI and Principal Investigator for the study.
David Joseph, CEO of Othera added, "We are very encouraged by OT-551’s
potential to preserve visual function in these patients with late-stage
dry AMD. The results of this study support OT-551’s potential as a
treatment for ocular diseases such as AMD where oxidative stress and
inflammation are involved.”
Abstracts of the posters to be presented at the ARVO 2010 annual meeting
can be accessed via the ARVO website: www.arvo.org,
and further information about the NEI can be found at their website: www.nei.nih.gov.