Biovitrum has Completed an Exploratory Clinical Phase II Study in Glaucoma
Biovitrum has completed a first explorative clinical Phase II study with the candidate drug BVT.28949, a 5-HT2A antagonist intended for the treatment of glaucoma. The preliminary results show a dose dependent reduction of the intraocular pressure; a reduction that amounted to 10% as compared to the pressure before treatment after four weeks at the highest dose.
The objective of the present explorative phase II study was to validate a novel mechanism (mediated via the 5-HT2A receptor) for the treatment of glaucoma, for the first time using a selective antagonist (BVT.28949). The study included 129 patients with an elevated intraocular pressure, with or without developed glaucoma. The study was double-blind, randomized, placebo-controlled and was carried out at several clinics in both Sweden and Ukraine.
The results show that BVT.28949 reduces the intraocular pressure and that the reduction is dose dependent. After 2 weeks of treatment a statistically significant reduction of the pressure as compared to placebo (p<0.003) was obtained at the highest dose, 7 mg/ml. At the end of the treatment, after 4 weeks, the reduction in pressure in that dose group was 10 % from starting pressure. However, the reduction was no longer statistically significantly different from placebo (p<0.067). The treatment was tolerable and safe.
BVT.28949 is a selective 5-HT2A antagonist (serotonin receptor 2A antagonist), suitable for topical administration in the form of eye drops. 5-HT2A-receptors control the outflow of aqueous humor from the eye globe. BVT.28949 lowers the intraocular pressure by increasing the outflow of aqueous humor and Biovitrums current hypothesis is that BVT.28949 acts through stimulation of outflow via the trabecular meshwork, unlike prostaglandins (e.g. Xalatan®) which reduce intraocular pressure through another outflow mechanism.
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