Ocugen, Inc., a biotechnology company based in Malvern, Pa. recently reported to BioSpace that DSMB gave a favorable review of its Phase ½ ArMaDa clinical study of OCU410. Approximately 10 million people in the U.S. and over 266 million individuals worldwide are affected by dAMD which in simple terms is thinning of the macula. The therapy, OCU410, is a modifier gene treatment that is now in development to treat advanced dry age-related macular degeneration (dAMD).
Secondly, geographic atrophy (GA) affects about 2 to 3 million individuals in Europe and the U.S.
Six trial participants who were diagnosed with GA received dosing in the Phase 1/2 trial. Three of the subjects received the low dose while the remaining three were dosed with a medium amount. Subsequently, three more subjects will receive the high dose of OCU410.
The macula is part of the retina that provides clear vision to our line of sight. dAMD affects about 85 to 90% of people with AMD. dAMD is associated with the retina’s slow deterioration and atrophy or loss of macular activity. The disorder may also involve sub macular drusen which is the appearance of small yellow and white dots on the retina.
The second group was reported to have completed their segment of the study. The three participants in the group received 200mL sub retinal injections which deliver the therapeutic suspension to the space under the sensory retina.
Judging by the reception, there has been considerable enthusiasm with respect to the ArMaDa clinical trial. Approximately 13 highly rated U.S. surgery centers have participated in the trial.
According to Peter Chang M.D, OCU410 Chair, and as recommended by the DSMB for the study’s expansion phase, administration of the injections will continue to include the high dose of OCU410 while concurrently initiating Phase 2 administration.
The Data and Safety Monitoring Board (DSMB) members are independent experts who monitor and give advice to NIDCR. The DSMB members provide their recommendations and expertise. Dr. Huma Qamar, Ocugen’s Chief Medical Officer, said that there were no severe adverse events in relation to OCU410 reported in either the low or medium dose groups.
Currently the approved treatments for GA require about 6-12 intravitreal injections each year. OCU410 addresses the pathways that cause dAMD providing extended benefits in the long-term to these patients.
About the Trials
The ArMaDa trial involves two phases. The first phase is an open-label phase whereby researchers and participants know whether a placebo or the medication is being administered. The Phase 2 study is a randomized dose-expanded study where participants will be randomized to one of two OCU410 treatment cohorts or to a group that is untreated (a control group).
