Exton, PA-Othera Pharmaceuticals Inc. has announced theinitiation of a phase II clinical trial by the National EyeInstitute (NEI) of Othera's topical eye drop OT-551 in patientswith geographic atrophy (GA). The NEI will investigate OT-551'spotential to slow enlargement of the atrophic area in the maculaand prevent progression to the vision-threatening advanced stagesof age-related macular degeneration (AMD).
Exton, PA-Othera Pharmaceuticals Inc. has announced the initiation of a phase II clinical trial by the National Eye Institute (NEI) of Othera's topical eye drop OT-551 in patients with geographic atrophy (GA). The NEI will investigate OT-551's potential to slow enlargement of the atrophic area in the macula and prevent progression to the vision-threatening advanced stages of age-related macular degeneration (AMD).
This phase II study will enroll 10 patients with bilateral GA who will receive three daily doses of OT-551 eye drop over 2 years. The primary efficacy measure will be percent change in area of GA in each eye, as measured by fundus photo grading. Secondary measures will include: progression to advanced neovascular or wet AMD, progression of GA area based on autofluorescence, changes in contrast sensitivity, drusen area, and best-corrected visual acuity, and number of eyes developing advanced AMD.
Additional outcomes will also be measured regarding lens opacity as part of an ongoing collaboration between Othera and the NEI on preventing or slowing the progression of cataract formation.
In other news, Othera has named Al Reaves, PhD, senior vice president of clinical development. Dr. Reaves has 22 years of ophthalmology drug development experience. He has been responsible for bringing numerous ophthalmic products to market, and previously led the verteporfin (Visudyne) global clinical development program at Novartis and worked with the Genentech/Novartis partnership for ranibizumab (Lucentis) approval in Europe. He has served as head of clinical and regulatory affairs at Xenon Vision, as well as manager of clinical research at Alcon Laboratories.