Celtrix Pharmaceuticals Inc.'s growth factor, BetaKine, canrestore vision most effectively in people with macular holes inthe retina who receive early treatment, according to Phase IItrial results presented Tuesday at the annual meeting of theAmerican Academy of Ophthalmology in Chicago.
A study of 93 patients found that 65 percent of those whobegan BetaKine treatment with better than 20/80 vision hadachieved 20/40 or better vision at six months follow-up. Bycomparison, only 19 percent of those with vision worse than20/80 had 20/40 or better vision after therapy.
BetaKine is applied around the edges of the macular holeduring the surgical extraction procedure known as vitrectomy.In January FDA granted the product orphan drug status fortreatment of macular holes, and last month the agency's Officeof Orphan Products Development awarded Celtrix $600,0000 tosupport Phase III trials.
Bert Glaser, director of the Retina Eye Institute of Maryland,presented one-year follow-up data on a second Phase II trial of90 patients. The study found that 97 percent of patientsreceiving high-dose BetaKine (1,300ng) had a flattening of themacular hole compared with 47 percent in the placebo group.
The findings are in line with preliminary three-month follow-up results reported in May (see BioWorld, May 5).
Glaser also reported that 79 percent of patients in the high-dose group showed two lines improvement or better, asmeasured on a standard eye chart, and 72 percent showed athree-line improvement. Only 30 percent of those in theplacebo group showed three line improvement.
Celtrix, of Santa Clara, Calif., plans to begin Phase III studies inthe coming weeks. -- Brenda Sandburg
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