BDM-E – OPHTHALMIC (EYE) DISEASE

BDM-E was discovered in Russia, and has been successfully used in some Russian clinics for the compassionate treatment of ophthalmic disorders.  

In September 2010 BioDiem received Orphan Drug designation from the United States Food and Drug Administration (FDA) for BDM-E for the treatment of Retinitis Pigmentosa. Retinitis Pigmentosa is a serious eye disease which causes progressive degeneration of the delicate light receptor cells in the retina, which, over time, diminishes night and peripheral vision and eventually leads to blindness. This condition affects between 1 in 3,500 to 4,000 people, equivalent to 77,000 and 88,000 people in the USA. Currently, there is no therapy that stops the evolution of the disease or restores the vision.

BioDiem’s preclinical work in Retinitis Pigmentosa has demonstrated promise. In vivo studies have shown that BDM-E is able to reduce the degree of retinal damage of the retinal cell layers. It has also been shown to exert a degree of protection of the retina in models of this disease. In another research model of light damage it prevented photoreceptor apoptosis (programmed cell death). Through the use of BDM-E in Russia and results of an earlier clinical trial, BDM-E has already shown a good safety profile in the dose administered.

Nonclinical studies at Monash University and the University of Melbourne have demonstrated that BDM-E produces positive effects in retinopathy of prematurity, a model of eye disease. These studies have been extended to other laboratory eye disease models such as diabetic retinopathy and age-related macular degeneration.  A review of the most recent nonclinical data is being undertaken to ascertain whether additional intellectual property can be established around analogues of BDM-E. The results completed thus far are commercial-in-confidence pending appropriate intellectual property protection. Subject to the results of the data review an outlicensing package will be finalised and study results presented and published in international forums. A partner is sought to continue the development of BDM-E for the indication of retinitis pigmentosa and other eye diseases.