Union City, CA—MacuSight Inc. is beginning a phase I study of its lead product candidate in patients with diabetic macular edema (DME).
Indianapolis, IN—Eli Lilly and Co. said it is "weighing its options" regarding further development of ruboxistaurin mesylate after the FDA requested an additional 3-year, phase III clinical trial of the molecule that could treat severe nonproliferative diabetic retinopathy.
In a retrospective analysis of the phase III MARINA study results, patients with neovascular age-related macular degeneration (AMD) who were treated with the 0.5-mg dose of ranibizumab (Lucentis, Genentech) had improvement in anatomic outcomes that corresponded to improved visual acuity and was compared to a sham group, according to Nancy M. Holekamp, MD.
Lenstec Inc. announced that the FDA has granted the company an Investigational Device Exemption (IDE) to begin a clinical trial of the Softec HD posterior chamber IOL.
Successful long-term management of glaucoma requires a full spectrum of tools. These may include new technologies and pharmaceutical agents as well as interventional approaches involving laser or surgical therapy.
Ruboxistaurin (Arxxant, Eli Lilly) may be a useful new tool to prevent visual loss from diabetic retinopathy based on the results of the DRS2 Study, reported Lloyd Aiello, MD, PhD, during Retina Subspecialty Day. The study showed a reduction in the sustained vision loss compared with placebo.
A total of 685 patients with type 1 or type 2 diabetes participated in this multicenter randomized phase III clinical study that was completed late in 2005, according to Dr. Aiello. He is associate professor of ophthalmology, Harvard Medical School, and investigator and head of eye research, Joslin Diabetes Center, Boston.
Waltham, MA—OxiGENE Inc., a clinical-stage biopharmaceutical company developing novel therapies to treat eye diseases and cancer, is now focusing its ophthalmology strategy on oral or other non-intravitreal forms of administration of Combretastatin A4 Phosphate (CA4P) for age-related macular degeneration.
Buffalo Grove, IL—Akorn Inc. has submitted the first abbreviated new drug application with the Office of Generic Drugs on behalf of FDC Ltd., India's second-largest manufacturer and marketer of ophthalmic pharmaceutical products.
Boston—Global bio-nanotech company pSivida Ltd. has begun a phase II clinical trial of the steroid receptor antagonist mifepristone (RU486) as an eye-drop treatment for steroid-associated elevated IOP. The investigator-sponsored trial is expected to involve up to 45 patients in the United States.
The FDA approved the over-the-counter use of ketotifen fumarate ophthalmic solution 0.025% (Zaditor) for the temporary prevention of itchy eyes due to allergic conjunctivitis. The drops treat eye itch associated with pollen, ragweed, grass, animal hair, and dander without the potentially negative effects of a decongestant.