![]() ![]() “However, by 18 and 24 months, the efficacy curves separated further in both clinical trials, and ultimately, pegcetacoplan demonstrated a clinically meaningful slowing of disease progression,” Wykoff said. ![]() The trial program involved over 1,500 patients treated for up to 2 years, with the phase 3 trials enrolling 1,258 patients,” Wykoff said.Īt 1 year, a statistically significant reduction in lesion growth was reported with monthly and every other month pegcetacoplan in the OAKS trial, while in the DERBY trial, the difference between the pegcetacoplan-treated patients and the sham arm failed to reach statistical significance. “There was a lot of work with the FDA to develop a primary endpoint that is suitable for this disease, and most recently the favored FDA-approvable endpoint is a slope analysis looking at the rate of change of geographic atrophy area over time as assessed by fundus autofluorescence. Defining the primary endpoint at the beginning of the clinical trial program was difficult because GA progresses slowly, making visual acuity unsuitable for this purpose. Wykoff, MD, PhD, told Healio/OSN.ĭrug development for FDA approval is a lengthy, arduous process, particularly for geographic atrophy (GA), a disease with unique characteristics and pathologic mechanisms. With the approval of a medication that slows the progression of GA with increasing efficacy over time, this has the potential to galvanize the field, encouraging innovation and the development of additional pharmacotherapies,” Charles C. “It is a landmark for patients, who historically had nothing, and it is also very meaningful for the field broadly because of all of the failed trials over the last decade. The approval of Syfovre, the first and so far only treatment for geographic atrophy, is a landmark transition in the retina space, comparable to the introduction of anti-VEGF therapies for wet age-related macular degeneration. ![]() If you continue to have this issue please contact to Healio ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |