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Prostaglandin analogue showing promise in clinical practice
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Projected clinical outcomes for the 0.01% formulation of bimatoprost appear to be on the mark, according to a clinician.
“We took an old product and improved upon it and made it easier to use in our patient population, so [bimatoprost 0.01%] did achieve its initial intent,” L. Jay Katz, MD, a chief investigator for a randomized, controlled U.S. Food and Drug Administration trial of the formulation, told Ocular Surgery News. “I think there is anecdotal acceptance of the phase 3 FDA trial that was published, that the message seems to ring true.”
According to Dr. Katz, Lumigan 0.03% (bimatoprost ophthalmic solution, Allergan) is considered the most potent drug on the market for lowering IOP, but its popularity has been hindered by its side effect profile. Red eye, in particular, is an unwanted complication that frequently steers patients in the direction of other prostaglandin analogues.
“Because of [side effects], Lumigan [0.03%] was not used very much as first-line therapy. The other prostaglandins, whether it was Xalatan (latanoprost ophthalmic solution, Pfizer) or Travatan (travoprost ophthalmic solution, Alcon), seemed to be a more attractive first-line choice,” Dr. Katz said.
Transition to first-line therapy
In engineering the 0.01% formulation, researchers sought to maintain the potency of bimatoprost 0.03% in lowering IOP while improving the drug’s tolerability.
The FDA trial conducted by Dr. Katz and colleagues, featured in the American Journal of Ophthalmology, demonstrated that the 0.01% formulation was as efficacious as its 0.03% counterpart over a 12-month postoperative period, with overall treatment-related complications reduced significantly in the 0.01% group. Most notably, conjunctival hyperemia decreased in frequency and severity.
In the past, Dr. Katz said, he generally used bimatoprost 0.03% only if he needed a significant, rapid pressure drop or if one of the other prostaglandins was not achieving a targeted pressure level. But with the newer 0.01% formulation, many of his patients start it as a first-line alternative to other prostaglandins.
Future of glaucoma therapeutics
It is difficult to introduce new brand products or medication classes into the glaucoma arena because the low cost of generic latanoprost combined with the overall effectiveness of prostaglandins makes it difficult to alter the existing treatment paradigm, according to Dr. Katz.
“It is a difficult time right now for brand products in this category, because just recently Xalatan’s patent expired, so now we have generic latanoprost, which is incredibly cheap in most parts of the country. And cost can be a very powerful influence on what people are going to use,” he said.
Because prostaglandins offer such well-tolerated, highly effective once-a-day therapy, Dr. Katz said he does not foresee a new class of glaucoma drugs replacing them in the immediate future.
“Companies trying to develop a new product are using latanoprost as a yardstick, and it is difficult to measure up to, so I do not think there are going to be any blockbuster drugs coming out anytime soon,” he said.
No new class of glaucoma therapeutics has emerged in roughly 15 years, with researchers focused more intently on modifying and enhancing existing products. – by Michelle Pagnani
Reference:
- Katz LJ, Cohen JS, Batoosingh AL, et al. Twelve-month, randomized, controlled trial of bimatoprost 0.01%, 0.0125%, and 0.03% in patients with glaucoma or ocular hypertension. Am J Ophthalmol. 2010;149(4):661-671.
- L. Jay Katz, MD, can be reached at Wills Eye Hospital Glaucoma Service, 900 Walnut St., Philadelphia, PA 19107; 215-928-3197; email: ljkatz@willseye.org.
- Disclosure: Dr. Katz is a consultant for and receives research grants from Alcon, Allergan, Merck and Aerie Pharmaceuticals
