Summary
This novel and potent fluoroquinolone designed exclusively for ophthalmic use will gain significant market share of the ocular antibiotics prescribed in the US at the expense of Vigamox (Alcon) and Zymar (Allergan), the current leaders. This will happen because cataract surgeons and contact lens specialists are concerned about the rising incidence of antibiotic resistance and MRSA (methicillin-resistant staph. aureus) infections. When it comes to eye infections (endophthalmitis, bacterial corneal ulcers), there is no margin for error and clinicians will always prescribe the most potent ophthalmic antibiotic available regardless of its cost and insurance formulary coverage.
Analysis
Although approved for the use in bacterial conjunctivitis, Besivance will primarily be used FDA off-label by eye surgeons for infection prophylaxis after cataract, LASIK, glaucoma, and cornea eye surgery. Approximately 15-17 million prescriptions are written annually for ocular antibiotics. Eye surgeons account for 25 to 30% of these scripts with the remainder written by primary care clinicians (pediatricians, family practice, internal medicine, etc) who most often use generic erythromycin. Within primary care, cost is always a concern and new antibiotics like Besivance will never gain market share when cheap, generic antibiotics that can effectively treat benign conjunctivitis are available. Thus, the primary clinicians who will use Besivance will be ophthalmologists and optometrists.
Among eye surgeons, Vigamox and Zymar each have about a 40% market share. Vigamox and Zymar are considered fourth-generation fluoroquinolones meaning they are more potent (effective bacterial kill) and are less likely to become resistant. Nevertheless, there have already been reported cases of resistance with Vigamox and Zymar. No eye surgeon (cataract) wants to use an antibiotic that is considered outdated and not the standard of care because even one infection case (post eye surgery endophthalmitis) can result in blindness. Similarly, corneal and contact lens specialists treating bacterial corneal ulcers do not want to be caught using an older antibiotic that may be resistant because the patient may go blind. There is no margin for error when treating or preventing eye infections - thus most will switch to the "latest and most potent" antibiotic on the market.
Although Besivance appears to be pharmacologically similar to Vigamox and Zymar, its success will depend on how Bausch and Lomb markets this product. If it is labeled as a new "fifth generation fluoroquinolone" as opposed to "fourth generation" like Vigamox and Zymar, many ophthalmologists/optometrists will switch because of the fear of using an outdated antibiotic and the fear of being involved in a malpractice suit. (when the expert witness accuses them of not conforming to the standard of care - "everyone else is using Besivance - why aren't you doctor."
Also, if Bausch and Lomb provides data of Besivance having anti-MRSA (methicillin-resistant staph. aureus) properties, every eye care provider will switch to this antibiotic because no commercially available topical antibiotic available can claim this feature. Antibiotic resistance is a big concern within the health care industry and the number of MRSA cases (both eye and systemic) continue to increase.
Finally, because of the recent changes in the codes of conduct/ethics/guidelines for the Pharma and Medical Device industry, there will be more transparency and less commerical influence on prescribing doctors. Thus, clinicians will be able to prescribe the best medication for their patient without any allegiance to one company. What I am talking about here is the agreement by the major eye companies - Alcon, Allergan, Bausch and Lomb - to stop providing free postop eye surgery kits, meals, gifts, etc to ophthalmologists. This is a very complicated topic that I will not discuss here but has significant implications for Besivance and all future eye medications.
