Key Takeaways:
Bausch + Lomb (NYSE:BLCO) will advance its dual-action dry eye drop to Phase III after a Phase II study showed significant day-15 corneal-staining improvement (p=0.0007).
"These results support our approach to developing differentiated therapies that have the potential to address significant unmet needs and change the standard of care in eye health," Chief Executive Officer Brent Saunders said.
The four-week, randomized, double-masked, active-controlled study enrolled 443 patients across six arms. At day 15, 41.6 percent of patients on the combination achieved a three-unit improvement in total corneal fluorescein staining, versus 18.8 percent on lifitegrast alone and 31.6 percent on PFHO alone. The day-29 primary endpoint missed statistical significance (p=0.196), though results numerically favored the combination.
Bausch + Lomb estimates combined peak sales of more than $2 billion for the two programs, with launches expected beyond 2028. The company said it remains on track for the three-year targets outlined at its November 2025 investor day.
BL1332, a topical TRPV1 antagonist, met its primary endpoint in a capsaicin-induced ocular pain model in healthy volunteers. Mean pain intensity fell to 0.6 versus 6.1 for vehicle, a 5.5-point reduction (p<0.0001). In exploratory analyses, 68.2 percent of treated eyes achieved complete pain resolution versus none on vehicle, and mean pain duration shortened to 1.6 seconds from 37.8 seconds. No treated eyes reported severe pain, compared with 36.4 percent on vehicle.
The molecule is roughly 100 times more potent and more water-soluble than Bausch + Lomb's earlier TRPV1 candidate, BL-1312. The company is evaluating BL1332 in a Phase II study of pain after photorefractive keratectomy surgery, with topline results expected in the coming months. Management said the mechanism may extend to pain associated with dry eye disease and other acute and chronic ocular conditions.
The Phase III advancement and BL1332's mechanism confirmation give Bausch + Lomb two potential growth drivers beyond 2028, with the dry eye program carrying an estimated $700 million in peak sales and BL1332 about $1.4 billion. Investors will watch the Phase II post-surgical pain readout in the coming months and the Phase III design details, which management said it will share shortly.
This article is for informational purposes only and does not constitute investment advice.
