Quark Pharmaceuticals announced the results from its Phase 2 trial of PF-04523655 (RTP801I-14) for the treatment of diabetic macular edema (DME). The prospective, randomized study evaluated the safety and efficacy of PF-04523655 in patients with DME. The study enrolled 184 patients who were randomly assigned to four treatment groups: three dose levels of PF-04523655 (RTP801I-14) (0.4mg, 1mg, and 3mg) or laser. The study was designed with a primary endpoint of mean visual acuity improvements over baseline at 24 months. Interim results at 12 months showed that there were no drug-related serious adverse effects. Following 12 months of treatment with PF-04523655 (RTP801I-14), a dose-dependent improvement in visual acuity was observed with the best results achieved at the 3mg dose level.
The study was terminated at 12 months, based on analysis suggesting that higher doses would be necessary to produce a superior therapeutic effect than the current standard of care. A Phase 2b study will be initiated to test higher doses of PF-04523655 (RTP801I-14) and determine the optimal dose.
For more information call (510) 402-4020 or visit www.quarkpharma.com.