DE-117, a new glaucoma therapy being developed by Santen Pharmaceutical산텐제약, recently won the approval of its Phase 3 clinical trial plan. DE-117 is drawing attention whether it can replace Xalatan (compound Latanoprost), the most frequently used treatment so far.
The Ministry of Food and Drug Safety (MFDS)식품의약품안전처 has approved Phase 3 clinical trials to test the safety and effectiveness of DE- 117 eye drop 0.002% compared with Latanoprost eye drop 0.005% for people with open-angle glaucoma or high intraocular pressure. The multinational and multi-organizational clinical trials, called the PEONY research, have started in Asian countries since December.
DE-117 reportedly works for the non-prostaglandin selective EP2 receptor, relaxing the ciliary muscle and reducing intraocular pressure through uveal hardening lines.g
The Phase 2 clinical trials confirmed safety, efficacy, and dosage by comparing Latanoprost (0.005%) with four different dosages of DE-117 (0.0003%, 0.001%, 0.002%, 0.003%) for 91 open-angle glaucoma patients. According to the research, patients who took DE-117 0.002% showed the higher reduction of intraocular pressure in the first week than those who took Latanoprost and similar decrease with Latanoprost until the fourth week.
The Phase 3 trials will compare DE-117 0.002%, which has shown effects on reducing intraocular pressure, with Latanoprost.
The most widely used glaucoma treatment now is Xalatan made by Pfizer화이자제약. Since winning the approval of the U.S. Food and Drug Administration (FDA) in 1996, it has been the best-selling glaucoma therapy in the world.
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