Othera Pharmaceuticals Reports Preserved Visual Function in Clinical Trial of OT-551 Eye Drop Treatment for Advanced Dry AMD
WEST CONSHOHOCKEN, Pa.--(BUSINESS WIRE)--Mar 23, 2010 - 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.
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.
Contact: Othera Pharmaceuticals, Inc.
Othera VP Finance and Business Development
Posted: March 2010