PURPOSE: A Phase 2 trial evaluated the safety and efficacy of BL1107 (formerly WB007), a potent, targeted alpha2 agonist in development, to lower intraocular pressure (IOP) and acutely improve vision in patients with glaucoma.

METHODS: 59 patients with glaucoma were enrolled in a 14-day randomized controlled trial comparing BL1107 (0.15% and 0.4%) to timolol (Tim) 0.5% each administered topically twice daily. Mean change from baseline IOP at Day 14 Hour 2 was the primary efficacy endpoint. Endpoints also included mean deviation in decibels (dB) on Humphrey visual fields (HVF) and best refracted low-luminance visual acuity (LLVA). Safety data including adverse events were collected at all study visits. A sample size of 24 per group had >90% power to detect a within-group mean change from baseline of at least 3 mmHg assuming a standard deviation of 2.5 and a two-sided alpha of 0.05, and 91% power to detect between group treatment differences of at least 3 mmHg.

RESULTS: Baseline demographics and IOP were well balanced among groups. Subjects receiving BL1107 were slightly older and baseline IOP was slightly lower compared to subjects receiving Tim. Both doses of BL1107 met the primary endpoint. Within-group mean change from baseline IOP was -4.9, -5.1, and -6.0 mmHg for BL1107 0.15%, BL1107 0.4%, and Tim 0.5%, respectively (p<0.001 for each. between group differences were not statistically significant. bl1107 demonstrated statistically significant improvements in mean deviation on hvf in study eyes 1.4 db bl1107 0.15 vs. tim p="0.046)" and in treated non-study eyes 2.4 db bl1107 0.15 vs. tim p="0.002" and 1.8 db bl1107 0.4 vs. tim p="0.012)." more patients receiving bl1107 had a>15-letter improvement in LLVA in study eyes compared to timolol: 8.7% for BL1107 0.15%, 16.7% for BL1107 0.4%, and 0% for Tim (p>0.05) although the study was not powered for this endpoint. BL1107 was well tolerated. There were no clinically meaningful changes in vital signs, laboratory values, or pupil size with any treatment. Adverse events with BL1107 were mostly mild, transient, and did not lead to discontinuation.

CONCLUSIONS: BL1107 significantly lowered intraocular pressure and demonstrated improvements in visual function compared to timolol. The acute improvements in vision are being investigated in a larger clinical trial.