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news.MacuSight, a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, has announced positive preliminary data from a Phase I study of its lead product candidate in patients with wet age-related macular edema or wet AMD.
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The preliminary results from this prospective study of 30 patients demonstrated that MacuSight’s proprietary formulation of sirolimus (rapamycin) was safe and well-tolerated in all doses tested with two different routes of administration. In addition, improvements in visual acuity consistent with anatomical retinal changes were observed following a single administration of sirolimus.
As part of the design of this randomized, open-label study, investigators evaluated the safety, tolerability and biological activity of sirolimus when delivered by either a subconjunctival or intravitreal injection. The trial showed no evidence of increased intraocular pressure, inflammatory response to treatment, or indication of progression of cataracts. Furthermore, the study provided an initial assessment of sirolimus’s biological activity in AMD with patients demonstrating improvements in visual acuity despite extended duration of disease prior to entering the study. Additionally, patients also experienced anatomical improvements as demonstrated by a reduction in retinal thickness. These preliminary findings demonstrated that sirolimus administered via subconjunctival injections was as effective, if not more so, than sirolimus administered via intravitreal injections.
Joel Naor, chief medical officer of MacuSight, said: “Based on the positive findings from both our wet AMD and DME studies, we are preparing to initiate Phase II trials in both of these important indications, as well as additional ocular diseases and conditions.”