Archive for March, 2008

MacuSight treatment for AMD safe

MacusightData from a Phase I study of sirolimus (rapamycin), MacuSight’s treatment for wet age-related macular edema (AMD), suggests its safety in all doses tested in two ways of administration. The study was randomized and open label and there was no indication of increased intraocular pressure, inflammatory response to treatment or indication of progression of cataracts. Patients reported an improvement in visual acuity, despite extended exposure to the disease.

Device using electric current for curing eye diseases

ScyFix logoScyFix has developed a device that treats eye diseases, such as glaucoma and macular degeneration, with electric currents. The clinical trials are currently underway in India and the U.S. The company hopes to be the first to introduce an FDA approved device designed to restore eyesight. Until now, the use of electricity to slow or even reverse the effects of eye diseases has never made it out of a laboratory, said Dr. Thomas Samuelson, a founding partner of Minnesota Eye Consultants.

FDA grants Durezol priority review status

Sirion Therapeutics Inc. hSiron Therapeutics Logoas received FDA approval for its New Drug Application (NDA) for Durezol(TM). The FDA has granted the drug priority review, which means that the review would be completed in six months from the date of receipt of the NDA. The NDA is for Sirion Therapeutics’ investigational compound Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a twice-daily steroid, as a treatment for postoperative ocular inflammation.