Bausch + Lomb Will Present New Scientific Data And Analyses On Products And Pipeline Programs During ARVO 2021

Bausch + Lomb announced the presentation of new scientific data and clinical analyses, including one podium presentation and 11 poster presentations, during the virtual Association for Research in Vision and Ophthalmology (ARVO) annual meeting, which will take place from May 1-7, 2021. The virtual presentations will feature several of the company’s prominent products from its pharmaceutical, surgical and vision care portfolios, as well as data from the company’s ongoing Antibiotic Resistance Monitoring in Ocular micRoorganisms (ARMOR) surveillance study. Analyses on the company’s investigational drug Xipere (triamcinolone acetonide suprachoroidal injectable suspension) will also be highlighted.¹

“The new data and analyses we are presenting at ARVO this year represent our ongoing commitment to research and development across our business and to providing practitioners with new information that can help inform the treatment and care of their patients,” Joe Gordon, U.S. president, Bausch + Lomb, said in a company news release. “Among the data to be featured are insights from our ARMOR surveillance study, which continues to be the only ongoing multicenter study in the United States that monitors in vitro antibiotic resistance among ocular pathogens, and data on Xipere. We are proud to support these important studies and share the latest findings with eye care professionals during the ARVO meeting.”  

The ARMOR study analyses will be featured in both a podium presentation, examining the antibiotic resistance trends among staphylococcal isolates collected in the ARMOR study since 2009, and a poster presentation outlining the preliminary analysis of the 2020 ARMOR results. The ARMOR study findings allow eye care professionals to track in vitro susceptibility rates for commonly used antibiotics.

Another poster from the company’s vision care portfolio will evaluate the osmoprotective effects of the Bausch + Lomb Infuse silicone hydrogel (SiHy) daily disposable contact lenses packaging lens solution, kalifilcon A(KA), as compared to six other SiHy daily disposable packaging solutions. Bausch + Lomb Infuse lenses received 510(k) clearance from the FDA in August 2020.

From the company’s surgical portfolio, one poster will evaluate the increased hydroxyl radical scavenging activity of ClearVisc dispersive ophthalmic viscosurgical device (OVD) and a cohesive OVD. Bausch + Lomb announced the FDA approval of ClearVisc in April. A second poster will analyze the acoustic pressure of 23-, 25- and 27-gauge vitrectomy needles to measure the power, energy-tissue interaction and safety of Vitesse ultrasonic device, and another poster will compare the optical performance of IOLs with three optical designs using an optical raytracing simulation method.

Four other posters will feature new data from the Bausch + Lomb pharmaceuticals portfolio. The first will feature findings from the company’s pharmacovigilance database of the occurrence of steroid-associated adverse events related to Lotemax SM (loteprednol etabonate ophthalmic gel) 0.38% and all other Lotemax formulations. Another will evaluate the differences in dose uniformity between Lotemax SM and another corticosteroid suspension product when shaken or not shaken.

The last two pharmaceutical posters will feature data on blepharitis, which is an inflammation of the eyelids that makes them red, irritated and itchy with dandruff-like scales that form on the eyelashes. One will evaluate the in vitro activity of tobramycin, the antibacterial in Zylet (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension), against common bacterial pathogens associated with the disorder, and the other will compare the in vitro activity of eight antibiotics across six drug classes frequently used to manage blepharitis caused by staphylococci (“staph” bacteria).

The remaining two posters, which will be presented by Clearside Biomedical, Inc., will feature unpublished data on the investigational drug, Xipere. The first poster, a post hoc study, will evaluate the safety of suprachoroidal injections (SCIs) utilizing the SCS Microinjector across multiple clinical trials, and the other poster will analyze the procedural characteristics of SCIs in two noninfectious uveitis trials.

The full schedule of research (by date) to be presented includes:

Sunday, May 2

• “Monofocal, Diffractive Trifocal and EDOF IOLs.” Xie et al.
• “New Ophthalmic Viscosurgical Device (OVD) with Enhanced Hydroxyl Radical Scavenging Activity.” Erb et al.

Monday, May 3

• “Analysis of Longitudinal Antibiotic Susceptibility Trends in Staphylococci: Results from 12 Years of the ARMOR Study.” Asbell et al.
• “Post hoc Analysis of Clinical Suprachoroidal Injection Experience for Non-infectious Uveitis.” Shah, M.
• “Safety of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders.” Sharma, S.

Tuesday, May 4

• “In Vitro Potency of Tobramycin Against Common Bacterial Pathogens Implicated in Blepharitis.” Deom et al.

Thursday, May 6

• “Acoustic power measurements of ultrasonic vitrectomy device and the effects in pig eyes.” Papour et al.

Friday, May 7

• “Dose uniformity of loteprednol etabonate (submicron) ophthalmic gel 0.38% compared with prednisolone acetate ophthalmic suspension 1.0%.” Marlowe et al.
• “Occurrence of steroid-associated adverse events with loteprednol etabonate formulations.” Cavet et al.
• “Interim Analysis of Antibiotic Resistance from Bacterial Pathogens Collected in the 2020 ARMOR Study.” Sanfilippo et al.
• “Comparative In Vitro Activity of Antibiotics Frequently Used in the Management of Staphylococcal Blepharitis.” Kissling et al.
• “Comparative Analysis of the Osmoprotective Effects of a Novel Contact Lens Packaging Solution on Human Corneal Epithelial Cells.” Byrnes et al.

References

1. In October 2019, an affiliate of Bausch Health acquired an exclusive license from Clearside Biomedical for the commercialization and development of XIPERE in the United States and Canada.