Bausch + Lomb has chosen to advance two of its pharmaceutical assets further down the clinical pipeline, despite one of the drugs posting mixed data.
The first therapy the Canadian company will progress is its eye drop designed to treat dry eye, which will advance to Phase III development after the medicine showed efficacy in certain aspects of a Phase II study.
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In a four-week study, the twice-daily drug, which combines lifitegrast with perfluorohexyloctane – the active ingredients in its Novartis-acquired medicine, Xiidra and its Novaliq-licensed therapy, Miebo – failed to demonstrate statistical superiority over lifitegrast alone in reducing levels of corneal staining, missing the trial’s primary endpoint.
However, the combination did demonstrate a numerical trend toward benefit at day 29, and a pre-specified secondary analysis at day 15 highlighted a statistically significant mean change in corneal staining within patients treated with lifitegrast-perfluorohexyloctane. Bausch & Lomb claims that the FDA accepts 15 days as a timepoint for a registrational study in dry eye.
The two drugs used in tandem also exhibited a similar safety profile to the drugs on their own, with researchers identifying no new safety signals.
While lifitegrast-perfluorohexyloctane may not have ticked all the efficacy boxes, Bausch & Lomb’s CMO and executive VP of R&D, Yehia Hashad noted that the “pre-specified result … achieved with less drug than the individual therapies, and the ability to increase the dose based on an acceptable safety profile” prompted the company to advance the drug to Phase III with “high conviction”.
While regulators have approved multiple therapies for dry eye, none tackle both inflammation and tear evaporation in a single product. Bausch & Lomb hopes to change this with its dual-action eye drops.
BL1332 heads to Phase II on positive surface pain data
Alongside the progression of its eye drop formulation, Bausch + Lomb is also eyeing the progression of its ocular surface pain candidate, BL1332 to Phase II after the drug significantly reduced pain intensity caused by a challenge with the ‘spicy’ chemical in chillis compared with vehicle.
In this Phase Ib trial, the company evaluated the potential of the ophthalmic solution in healthy volunteers – finding that after five seconds following capsaicin challenge, eyes treated with BL1332 experienced a 5.5-point drop in average pain intensity versus vehicle. Meanwhile, 68.2% of eyes treated with the drug experienced complete resolution of pain compared with 0% in the vehicle arm, while no participants given BL1332 reported severe pain, versus 36.4% of vehicle-treated individuals.
According to Bausch + Lomb, these results validate the TRPV1 antagonist mechanism – providing a foundation for the company to test the drug in patients with relevant eye pain conditions.
Bausch + Lomb is currently exploring BL1332’s potential in an ongoing Phase II study in patients with pain post-eye surgery.
