Ophthalmology Times Staff Reports

Bausch Health Companies Inc. (BHC) announced in a prepared statement today its decision to spin off its eye health business into an independent publicly traded company, Bausch & Lomb-NewCo, that will be separate from the other Bausch Health entities.

By so doing, BHC anticipates a number of benefits from this action, namely, unlocking value in the Bausch + Lomb brand and integrated portfolio of eye health products, facilitating BHC focus on expanding leadership in gastroenterology, aesthetics/dermatology, neurology, and international pharma, and enhanced focus on and highlighting of two attractive but dissimilar businesses, according to the statement.

This action, according to BHC, will result in 2 separate companies, specifically, a fully integrated, pure play eye-health company built on the iconic Bausch + Lomb brand and long history of innovation; and a diversified pharmaceutical company with leading positions in gastroenterology, aesthetics/dermatology, neurology and international pharmaceuticals.

Bausch & Lomb said it anticipates that this action will “improve strategic focus and enhance financial transparency to better enable stakeholders to value each business independently.”

"We are committed to taking action to unlock what we see as unrecognized value in Bausch Health shares, and we believe that separating our business into two highly focused, stand-alone companies is the way to accomplish that goal," said Joseph C. Papa, chairman and CEO of Bausch Health.

Four years ago, the organization initiated a multiphase plan, first to stabilize and then to transform Bausch Health into a company positioned to deliver long-term organic growth, Papa noted.

“We have divested approximately $4 billion of non-core assets, paid down over $8 billion of debt, resolved numerous legacy legal issues and managed a loss of exclusivity on an approximately $1.4 billion product portfolio, while also investing in R&D, new product launches­­ and core franchises with attractive growth opportunities,” he continued. “Our Board of Directors and management team have been working on alternatives over the last 12 months to determine how to best unlock value across our businesses, and we believe that the time is right to begin the separation process, so each business has greater flexibility to pursue strategic opportunities in their respective markets."

It is anticipated that after satisfying certain conditions and approvals and completion of other actions, reporting is expected to begin in the first quarter of 2021.

Bausch + Lomb - NewCo, will include Bausch Health's global vision care, surgical, consumer and ophthalmic Rx businesses. The company explained that the combination of pipeline expansion and established durable eye care brands, including BAUSCH + LOMB ULTRA, Biotrue ONEday, LUMIFY, Ocuvite and PreserVision, among others, and the launch of BAUSCH + LOMB INFUSE contact lenses, is expected to drive what is expected to be consistent revenue growth worldwide.

BHC will include a diversified portfolio of leading durable brands across the Salix, International Rx, Solta, neurology and medical dermatology businesses. Core products include XIFAXAN, TRULANCE and RELISTOR for gastrointestinal diseases; JUBLIA, DUOBRII and Thermage FLX for dermatologic conditions; and WELLBUTRIN and APLENZIN for neurological conditions.

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This action will result in 2 separate companies

Bausch Health: Spin-off of eye health business

Results from a phase I study of KVD001 (KalVista Pharmaceuticals) for the treatment of central involved diabetic macular edema (CIDME) show that this plasma kallikrein inhibitor was well-tolerated.

	In addition, it was not associated with any ophthalmic or systemic safety signals, and led to fairly long-lasting improvements in visual acuity (VA) and central retinal thickness (CRT) after a single intravitreous injection.

	“In the current era, it is very clear that anti-VEGF intravitreous injection is first-line therapy for most eyes with CIDME," said Jennifer Sun, MD, Joslin Diabetes Center, Boston. "However, there is a substantial proportion of patients who do not completely and successfully resolve their DME or gain vision to 20/20 or better. And so, there is also a clear need for alternate agents and alternative targets.”

	The data from this first in-human trial of KVD001 support progression to larger controlled phase II studies to further assess its potential efficacy and safety for treatment of CIDME, Dr. Sun added.

Navigating the ethics involved in using anti-VEGFs for pediatric patients

	KVD001 is a very potent and selective competitive inhibitor of plasma kallikrein. The phase I study investigating it in patients with CIDME had an open-label, single ascending dose design. Its primary objective was to assess local and systemic safety, but data to characterize pharmacokinetics and pharmacodynamics signals were also analyzed.

	A total of 14 eyes were treated, receiving doses of 1 µg/100 µL (n=3), 3 µg/100 µL (n=3), or 10 µg/100 µL. All eyes had received previous anti-VEGF therapy and five had a history of steroid treatment.

	Summarizing the data, Dr. Sun said there were no concerning drug-related ophthalmic or systemic safety signals.

Developing cell-based therapies for inherited retinal disease

	Systemic absorption of KVD001 was low, and there was some improvement in both VA and CRT in most study eyes.

	No eyes required rescue treatment for CIDME through day 56 and 12 of 14 eyes were followed to day 84 without requiring additional treatment. Mean HbA1c was stable over the study duration.

	“We saw a favorable effect of treatment in terms of best-corrected visual acuity and CST in the 12 patients followed to day 84, which is a fairly late duration response after a single injection,” Dr. Sun said. “This finding raises the question of whether KVD001 has prolonged durability and whether we may see it provides efficacy beyond the 30-day dosing interval that is typical for our other treatment alternatives.”

Neuroprotective treatment promising for macular telangiectasia

Results from a phase I study of KVD001 (KalVista Pharmaceuticals) for the treatment of central involved diabetic macular edema (CIDME) show that this plasma kallikrein inhibitor was well-tolerated, not associated with any ophthalmic or systemic safety signals, and led to fairly long-lasting improvements in visual acuity (VA) and central retinal thickness (CRT) after a single intravitreous injection.

Author | Ophthalmology Times Staff Reports

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Bausch Health: Spin-off of eye health business

DME therapy with plasma kallikrein inhibitor showing promise