Bausch + Lomb is advancing two first-in-class ocular surface therapies following new clinical trial results, including a dual-action dry eye drop headed for Phase 3 and the TRPV1 antagonist BL1332, which showed positive Phase 1b data in an ocular pain model.
The company’s investigational dry eye therapy combines 5% lifitegrast – the active ingredient in Xiidra – with perfluorohexyloctane (PFHO) – the active ingredient in Miebo – in a single twice-daily formulation designed to address both ocular surface inflammation and tear evaporation.
In a four-week, randomized, double-masked Phase 2 study involving 443 adults with dry eye disease, the combination was compared with lifitegrast alone, PFHO alone, and three vehicle controls. The study did not meet its primary endpoint of superiority over lifitegrast alone in reducing total corneal fluorescein staining (tCFS) at Day 29, although results numerically favored the combination (p=0.196).
However, a prespecified secondary analysis at Day 15 showed a significant reduction in mean tCFS change from baseline with the dual-action therapy compared with lifitegrast alone (p=0.0007). At that timepoint, 41.6% of patients receiving the combination achieved a three-unit or greater improvement in tCFS, versus 18.8% with lifitegrast and 31.6% with PFHO. No new safety signals were identified.
Bausch + Lomb said it will move the treatment into Phase 3 using Day 15 as the primary endpoint. The company noted that the investigational formulation uses more than 50% less lifitegrast volume than Xiidra and is dosed at half the frequency of Miebo.
“This was the first time this combination has been studied in humans, and it did exactly what a Phase 2 should do: demonstrated a rapid, robust treatment effect and told us precisely when to measure it,” commented Yehia Hashad, executive vice president, R&D and chief medical officer at Bausch + Lomb. “With a pre-specified result of this strength at a registrationally accepted timepoint achieved with less drug than the individual therapies, and the ability to increase the dose based on an acceptable safety profile, we’re advancing to Phase 3 with a clear design and high conviction.”
Bausch + Lomb stated that Phase 3 program details will be announced in the coming months.
Separately, BL1332 – a topical TRPV1 antagonist designed to target ocular pain signaling – met its primary endpoint in a Phase 1b capsaicin-induced ocular pain study in healthy adults. Five seconds after challenge, treated eyes showed a 5.5-point greater reduction in mean pain intensity than vehicle. Complete pain resolution occurred in 68.2% of BL1332-treated eyes compared with none receiving vehicle, while mean pain duration was 1.6 seconds versus 37.8 seconds, respectively.
BL1332 is now being evaluated in a Phase 2 study of patients experiencing pain following photorefractive keratectomy, with topline results expected in the coming months.
Of the ongoing Phase 2 results of BL1332, Hashad commented: “These results provide the first clinical evidence that targeting TRPV1 can meaningfully reduce ocular pain in humans that have not just undergone surgery. They also strengthen our confidence in the mechanism as we continue evaluating BL1332 in patients with clinically relevant pain conditions.”
The company added that BL1332 could have potential “across multiple ocular surface pain conditions,” and that any future decisions will be based on discussions with regulatory authorities and the ongoing clinical results.
Source: Bausch + Lomb.
