SpyGlass Pharma announced positive results from 2 clinical trials of its lead product candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), for the treatment of elevated intraocular pressure (IOP) in patients with mild-to-moderate open-angle glaucoma (OAG) or ocular hypertension (OHT). According to a company press release, the data were presented by Malik Kahook, MD, cofounder and president of SpyGlass Pharma, at the Interventional Glaucoma Consortium (IGC) in Salt Lake City on November 8th, which included 36-month follow-up data from the first-in-human (FIH) trial and 3-month interim safety and efficacy results from the phase 1/2 trial.
According to the company, the FIH results at 36 months showed a 37% reduction in mean IOP in evaluable patients across all dose groups from 25.1±2.5 mmHg at baseline post-washout to 15.9±2.7 mmHg. In addition, 95% of evaluable patients were off all topical IOP-lowering medications. Also, 100% of evaluable patients achieved 20/30 or better best corrected distance visual acuity (BCDVA), and no product-related AEs were reported.
The primary endpoint of the phase 1/2 trial is mean IOP reduction from baseline at the 2-week, 6-week, and 3-month time points following implantation of the SpyGlass BIM-IOL System delivering bimatoprost at 2 dose levels (78 μg and 39 μg). The BIM-IOL System achieved a mean reduction in IOP that was comparable to the control group, which received a commercially available monofocal intraocular lens (IOL) with twice-daily timolol eye drops, the company said.
According to SpyGlass Pharma, at 3 months patients achieved a 37% and 36% reduction in mean IOP from baseline in the 78-μg and 39-μg dose groups, respectively, compared to a 37% reduction in the control group at 8 AM. Results were similar at the 10 AM time point (Figure 1). In addition, 98% of patients (49 of 50) in the 78-μg dose group and 96% of patients (22 of 23) in the 39-μg dose group were free from all topical IOP-lowering medications. Patients demonstrated vision improvement, reaching 20/40 or better BCDVA and mean BCDVA of 85 to 86 letters (~20/20 vision).
In addition, the phase 1/2 safety results, comparable to routine cataract surgery
at 3 months, showed adverse event (AE) rates were similar across the 78-μg (35.3%), 39-μg (39.1%), and control (33.3%) groups, and no serious ocular AEs were observed. GP