Bausch + Lomb has released clinical outcomes for two pharmaceutical assets in its dry eye disease (DED) pipeline—along with phase 2 and 3 clinical advancement plans.
Two new DED assets?! Tell me more.
We’ll start with the dual-action eye drop, which combines the active ingredients of its two FDA-approved eye drops:
The topical therapeutic is formulated as a single, twice-daily (BID) treatment that addresses two of the primary underlying causes behind DED: ocular surface inflammation and tear evaporation.
And what’s the clinical update for this drop?
That would be phase 3 plans … which are currently in the works following the company’s phase 2 data readout.
Regarding that phase 2 study: This was a 4-week, randomized, double-masked, parallel-group, active-controlled trial with the following setup:
- Participants: 443 DED patients (aged 18+)
- Design: patients enrolled across six arms to receive either:
- Dual-action eye drop
- Lifitegrast (alone)
- PFHO (alone)
- Three vehicle masking controls
And the primary endpoint?
That would be the dual-action eye drop achieving superiority over lifitegrast alone in reducing total corneal fluorescein staining (tCFS) from baseline at Day 29.
To note: Per B+L, this timeframe was selected in the absence of prior human data on the timing of the combined treatment effect.
So what were the outcomes?
While the study failed to meet its primary endpoint, the results were reported to numerically favor the dual-action drop (p = 0.196).
Any secondary?
Indeed, from a pre-specified secondary analysis at Day 15—which, per B+L, is an FDA-accepted timepoint as a registrational primary endpoint for tCFS.
- In this study: Analysis results showed a “significant reduction in mean change from baseline tCFS” for the dual-action drop compared to lifitegrast alone (p = 0.007).
Also at Day 15: 41.6% of dual-action eye drop-treated patients achieved a ≥3-unit improvement in tCFS compared to:
- 18.8% treated with lifitegrast alone
- 31.6% treated with PFHO alone
And its safety?
All three treatment groups’ safety profile was “consistent with the established profiles of XIIDRA and MIEBO, with no new safety signals identified.”
Worth noting (from B+L): The dual-action drop’s performance was achieved “with more than 50% less lifitegrast volume than XIIDRA and half the dosing frequency of MIEBO.”
The company described the drop’s safety profile as offering a “rapid treatment effect at a lower drug load and simplified dosing regimen.”
… and this is advantageous for phase 3 plans?
Indeed. B+L intends to utilize the drop’s profile to support the design of multiple phase 3 studies to “demonstrate superiority to both individual therapies.”
- The plan: to use a primary endpoint at Day 15.
Further details on this phase 3 program are expected in the coming months.
Alrighty, now to this other candidate you mentioned.
That would be BL1332.
- What it is: a topical (eye drop) transient receptor potential vanilloid 1 (TRPV1) antagonist designed to target a key receptor in ocular pain signaling
- How it works: By directly modulating the biological pathways responsible for ocular surface pain
- Its investigational indication: for the potential treatment of ocular surface pain in multiple forms: post-surgical, acute, and chronic conditions.
Wait, can you give me a quick rundown on TRPV1?
This is a primary molecular sensor for heat, acid, and tissue irritation on the ocular surface—with a major role in driving dry eye-associated and neuropathic ocular pain.
- See here for more on its involvement in the ocular surface.
Got it. So in regards to BL1332 …
According to B+L, the first-in-class eye drop has the potential to support development across multiple patient populations with ocular surface pain.
The basis of this thinking: recent data from a phase 1b study that evaluated BL1332 0.3% ophthalmic solution in a capsaicin-induced ocular pain challenge model among healthy adult patients (aged 18 to 65).
Tell me more.
In general: Patients were treated with one topical drop of either BL332 or a placebo comparator.
They were then assessed 5 seconds post-dosing for ocular pain severity (via a numeric pain rating scale [NPRS])—the primary outcome measure.
For more details on this study’s setup, see its Clinical Trials page (NCT07717918).
And the data?
B+L shared a few key findings.
First and foremost: The trial met its primary endpoint in demonstrating a “statistically significant reduction in pain intensity” versus vehicle.
- The numbers: At 5 seconds after capsaicin challenge, BL1332-treated eyes experienced a 5.5-point reduction in mean pain intensity versus vehicle (p < 0.001).
- The significance: This represents the first clinical confirmation of a TRPV1 blockade’s ability to reduce ocular pain in humans (beyond acute post-surgical pain).
Any secondary analyses?
How about exploratory? In those, the following was observed:
- 68.2% of BL1332-treated eyes achieved complete pain resolution compared with 0% of vehicle-treated eyes (p<0.0001)
- No BL1332-treated eyes reported severe pain (versus 36.4% of vehicle-treated eyes’ [p<0.01])
And how was patients’ pain duration?
The mean duration of pain following capsaicin challenge was shorter with BL1332 than with vehicle (1.6 versus 37.8 seconds; p<0.0001).
As for BL332’s safety profile: B+L reported this as “acceptable and consistent with previous clinical experience, with no new safety signals identified.”
Nice! So what’s next?
Phase 2 plans—which are ongoing. The company is now evaluating BL332 among a new category of patients: those experiencing pain following photoreactive keratectomy surgery.
The intent: to assess BL1332’s potential in a real-world clinical setting and represents the next step in defining the therapeutic profile of the program.
- Topline data is expected within the next few months … so stay tuned!