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Bausch + Lomb Releases Investigational in Vitro Data Results

Data were presented at the 2020 Ocular Microbiology and Immunology Group 54th Annual Meeting.

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(PRESS RELEASE) Bausch Health Companies and Bausch + Lomb announced the results of new investigational in vitro data showing that two benzalkonium chloride (BAK) preserved eye drops, Lumify (brimonidine tartrate ophthalmic solution 0.025%) redness reliever eye drops and Besivance (besifloxacin ophthalmic suspension) 0.6%, indicated complete inactivation of Severe Acute Respiratory Syndrome-related Coronavirus 2 (SARS-CoV-2 or COVID-19). These data were presented at the 2020 Ocular Microbiology and Immunology Group 54th Annual Meeting that took place virtually on Friday, Nov. 13, 2020.

“Our team presented investigational data that evaluated the in vitro antiviral activity of Lumify and Besivance against SARS-CoV-2, and the results indicated complete inactivation of the virus,” Joseph C. Papa, chairman and CEO, Bausch Health, said in a company news release. “The clinical relevance of this in vitro data is not known, and our intention is to further review these data to determine next steps, including potential discussions with regulatory agencies around the world.”

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In the study, researchers evaluated the in vitro antiviral activity of Lumify and Besivance against SARS-CoV-2 using a Vero E-6 host-cell system. Both Lumify and Besivance contain 0.01% BAK, a quaternary ammonium compound commonly used as a preservative in ophthalmic topical solutions. The activity of BAK against SARS-CoV-2 is not well understood.

Time kill testing of SARS-CoV-2 cultures was conducted by multiple dosing of each formulation at contact times representative of those recommended in the Instructions for Use in both products. All tests were conducted in triplicate and in accordance with ASTM E1052-20, suspension time-kill test for virus standard practices. Following the required contact time, test solutions were neutralized, serially diluted and inoculated onto the Vero E6 host-cell system. Test samples were incubated with the Vero E6 host-cells and after 4-9 days, the presence of residual viable virus was scored.

The results indicated complete inactivation of SARS-CoV-2 virus at all contact times. Log10 reductions for Lumify were ≥1.80, ≥2.14 and ≥2.02 at 8-hour, 24-hour and 72-hour contact times, respectively, and Log10 reductions for Besivance were ≥1.95 and ≥2.56 at the 24-hour and 72-hour contact times, respectively. The clinical relevance of these in vitro findings is not known.

Neither Lumify nor Besivance have been proven to prevent or treat COVID-19 in humans nor have they been approved for those uses by the FDA. Consumers and patients should only use these products in accordance with their directions for use and the directions of their doctor.

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