In a Phase I/II trial for OpRegen by Lineage Cell Therapeutics, retinal damage caused by dry AMD has ben reversed.
AMD is Age-related Macular Degeneration, and it’s the leading cause of blindness in people over 50. There are two types, wet and dry. Wet AMD involves leaking blood vessels and has multiple existing treatments. Dry AMD has been more elusive, as it is caused by the thinning of the macula of the eye overtime (causing atrophy of photoreceptors and retinal pigment epithelium.)
Dry AMD in its most severe form impacts over 2 million Americans currently, and there are no existing treatments. While most leading investigations have focused on targeting inflammation in the eye, Lineage is actually attempting to manufacture entirely new retina cells and transplanting them into the eye.
The procedure involves local anesthesia and only takes 30 minutes to complete.
The new retinal cells begin as pluripotent stem cells, which are then manufactured into mass amounts of retina cells that can then be transplanted into the diseased eye.
The ongoing trial for OpRegen involved 24 people, 12 of which were legally blind due to ADM. While the half of patients with more severe AMD were tested more for safety concerns, there was still a noticeable decrease in the waste material (Drussen) produced by the eye’s metabolic activities. Drussen is cleared by retina cells, and implanting healthy new cells may lead to a decrease in the material.
The remaining 12 patients with healthier vision saw greater improvements, including an increase in vision.
There have even been three cases of retinal restoration, previously thought to be an impossibility in humans. Later this year, Lineage will propose their next trial design to the FDA, while the three regeneration cases remain great proof of concept.
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