Over the last few days, Bausch + Lomb Corporation announced two major business developments that will bolster its eyecare portfolio—specifically within the glaucoma and geographic atrophy (GA) spaces:
- The purchase of Laguna Hills, California-based Whitecap Biosciences, LLC via an affiliate
- A new strategic collaboration with biopharma company City Therapeutics, Inc.
Let’s start with this acquisition; I’m not familiar with Whitecap …
Launched in 2015, the company's primary focus involved developing novel therapies for ophthalmic diseases. Specifically:
- Glaucoma
- Geographic atrophy (GA)
Its pipeline: WB007 ophthalmic solution, a highly potent alpha-2 adrenergic agonist in clinical development for glaucoma.
- On the clinical trial front: This investigational asset has reportedly already “successfully completed phase 2 clinical trials,” according to B+L.
- Additional studies are planned for both GA and glaucoma.
What do we know about that phase 2 clinical trial?
The two-part, interventional phase 1/2 study evaluated the safety and intraocular pressure (IOP)-lowering effects of WB007 among 77 participants (aged 18+) diagnosed with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) in both eyes.
The study design:
- Part 1: Three-period dose escalation evaluating three concentrations of WB007 following a single dose in one eye (in 18 participants):
- WB007 0.05%
- WB007 0.15%
- WB007 0.4%
- Part 2: Randomized, double-masked, parallel comparison evaluating two concentrations of WB007 (based on part 1 results) in both eyes compared with timolol maleate 0.5% (in 59 participants)
- Both concentrations of WB007 and the timolol 0.5% were dosed twice daily
- Duration: 14 days
- Both concentrations of WB007 and the timolol 0.5% were dosed twice daily
The outcome measures (for Part 2):
- Primary: Mean change from baseline in IOP at Day 14 (in study eye), measured at baseline and Day 14 (hours 0, 2, 4, and 8)
- Secondary: Mean IOP at Day 14 (in study eye), measured at baseline and Day 14 (hours 0, 2, 4, and 8)
And what was found?
The two doses of WB007 selected from Part 1 to be used in Part 2 were:
- WB007 0.15%
- WB007 0.4%
What we know: The data reportedly showed WB007 demonstrating an IOP reduction from baseline by Day 14—indicating significant potential for future use in treating glaucoma.
- To note: No participants discontinued the study.
Interesting … now we have to ask: Why purchase Whitecap?
Per B+L, this acquisition “strengthens [the company’s] expanding clinical-stage pipeline”—particularly within the GA and glaucoma space.
Yehia Hashad, MD, B+L’s chief medical officer and executive vice president, Research & Development, noted that glaucoma and GA are two areas where the company believes dramatic improvement is possible.
“Whitecap Biosciences’ investigational medicines show real promise when it comes to slowing vision loss and perhaps even improving vision for patients with glaucoma, which would be a long-overdue breakthrough,” he stated.
Lastly … any financial details on this acquisition?
Nope, the companies did not disclose any associated monetary value.
Alrighty … now let’s switch topics and talk about this new collaboration.
B+L is also kicking off a new partnership with City Therapeutics, Inc., a Cambridge, Massachusetts-based biopharmaceutical company, to develop a novel therapeutic for retinal diseases such as GA.
About City Therapeutics: The company is working to advance the “next-generation engineering of small interfering RNAs (siRNAs)”—known as “trigger” molecules that mediate RNAi—in order to improve and expand the reach of RNAi-based medicines.
- On the leadership front: The biopharma company was launched by veteran executives and scientists of the first generation of RNAi therapeutics.
Back up for a moment… what exactly is RNAi?
RNA interference (RNAi) is a biological process that uses a cell’s own DNA sequence to silence genes.
The mechanics of this: RNAi uses siRNAs to shut down protein translation by binding to the messenger RNAs that code for those proteins.
- Its potential: This natural process plays a key role in regulating protein synthesis as well as immunity—and may be used to treat diseases previously thought to be untreatable (such as glaucoma and GA, in this instance).
And in the case of City Therapeutics: The company’s siRNA engineering platform is being designed to deliver RNAi-based medicines and treat a broader range of prevalent disease indications.
- Learn more about its approach.
Got it. And how does this play into the B+L partnership?
According to City Therapeutics, the company will “leverage its next-generation RNAi engineering technologies to develop a novel RNAi clinical candidate” with a specific disease target for intravitreal (IVT) administration.
B+L’s role: If the company chooses to pursue the candidate for further clinical development, the company will be responsible for:
- Investigational new drug (IND)-enabling studies and clinical development
- Regulatory submissions
- Commercialization
As for City Therapeutics: It would retain all technology and product rights—“except where Bausch + Lomb exercises its right to exclusively license a candidate for ocular indications.”
Any chance there are financial details on this deal?
Yes! Per the collaboration’s terms, City Therapeutics has already received an upfront cash payment.
Pending B+L pursuing a candidate for additional clinical development, the biopharma company would also be “ eligible to receive contingent payments tied to development, regulatory, commercial and sales milestones of up to $485 million, as well as tiered royalty payments on net product sales.”