bauschhealth Archives - Medical Design Sourcing

Bausch Health takes step toward separating Bausch+Lomb

Bausch Health (NYSE:BHC) announced today that it transferred shares of its Bausch + Lomb to an existing subsidiary.

The Laval, Quebec–based company transferred common shares in an amount equal to approximately 38.6% of the issued and outstanding shares of Bausch + Lomb to an existing, wholly-owned, unrestricted subsidiary of the company.

According to a news release, common shares amounting to approximately 50.1% of Bausch + Lomb continue to be held by a wholly-owned, restricted subsidiary as the optical and ophthalmic device maker itself remains a restricted subsidiary of Bausch Health.

Through its subsidiaries, the company continues to hold the same number of shares as it did prior to the internal transfer, which comprises approximately 88.7% of the issued and outstanding shares of the subsidiary.

According to the company, the internal transfer of shares is consistent with its commitment to the separation of Bausch + Lomb and offers “strate…

Bausch + Lomb, Clearside Biomedical launch Xipere in U.S.

Bausch Health’s (NYSE:BHC) Bausch + Lomb and Clearside Biomedical (NSDQ:CLSD) today launched their Xipere product in the U.S.

Clearside Biomedical designed the Xipere triamcinolone acetonide suprachoroidal injectable suspension therapy with a proposed indication for treating macular edema associated with uveitis — a form of eye inflammation. Xipere works with Clearside’s proprietary SCS Microinjector to deliver the therapy to the back of the eye where sight-threatening disease occurs.

Get the full story at our sister site, Drug Delivery Business News.

FDA accepts resubmitted NDA for Xipere from Clearside Biomedical, Bausch Health

Bausch Health (NYSE:BHC) and Clearside Biomedical (NSDQ:CLSD) announced today that the FDA accepted their resubmitted new drug application for Xipere.

Clearside Biomedical designed the investigational Xipere triamcinolone acetonide suprachoroidal injectable suspension therapy with a proposed indication for the treatment of macular edema associated with uveitis. Xipere works with Clearside’s proprietary SCS Microinjector to access the back of the eye where sight-threatening disease occurs.

Get the full story at our sister site, Drug Delivery Business News.

FDA approves Bausch + Lomb dispersive ophthalmic viscosurgical device

Bausch + Lomb announced today that it received FDA approval for its ClearVisc dispersive ophthalmic viscosurgical device (OVD).

Laval, Quebec-based Bausch + Lomb, the eye health business unit of Bausch Health, developed the ClearVisc OVD for use in ophthalmic surgery to aid in cataract extraction and intraocular lens (IOL) implantation through the creation and maintenance of space, tissue manipulation, visualization enhancement and corneal endothelium protection, according to a news release.

ClearVisc contains the chemical agent Sorbitol, which is designed to deliver superior free radical protection when compared to other dispersive OVDs. The device helps to provide physical protection of the cornea from thermal and mechanical damage, as well as the chemical protection from damaging free radicals.

A multicenter, randomized clinical study of 372 subjects saw ClearVisc meet its primary safety and efficacy endpoints, while the device proved non-inferior to …