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Today, RXi Pharmaceuticals (RXII) announced that it has initiated its Phase 1/2 trial for retinal scarring of Wet-Age related macular degeneration — Wet AMD. Wet-AMD is a disease characterized by blood vessels in the eye leaking blood into the macula, reducing vision for these patients. The anti-VEGF drugs out there coming from Regeneron Pharmaceuticals (REGN) Eylea and Roche (RHHBY) Lucentis deal with the leaking of the blood vessels portion. 

Unfortunately these Wet AMD patients also form underlying scars in the eye which the anti-VEGF treatments noted above don’t treat. Rxi is implementing its RXI-109 scar drug to help reduce these scars that form in the eye due too Wet-AMD. By being able to reduce these scars the company believes that it can help preserve vision in these patients for longer periods of time. 

The phase 1/2 trial will be known as RXI-109-1501 that will evaluate the safety and efficacy of the RXI-109 in patients with Wet-AMD. The patients in the study will receive 4 doses of RXI-109 at one month intervals over a 3-month period. In the fourth month patients will be evaluated for safety and efficacy of the drug. Efficacy will be measured by ocular health and visual acuity — vision improvement. 

This is a major effort for Rxi because like its positive phase 2 results in skin scarring, there are no approved therapies for retinal scarring of the eye. The company will first evaluate the drug in patients with Wet-AMD, but other patients that can benefit from injections of RXI-109 in the eye are patients with proliferative vitreoretinopathy — retinal scar due to eye detachment — and proliferative diabetic retinopathy. We believe that as RXI-109 has been successful in its phase 2 scarring program, it should also see good efficacy for patients with retinal scarring of the eye as well.