Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Valeant Pharmaceuticals International, Inc. (VRX), recently announced that its wholly owned subsidiary, Bausch + Lomb, released positive results from a phase III study on Lotemax.
The multi-center, double-masked, vehicle-controlled, parallel-group study showed that a next next-generation, sub-micron 0.38% gel formulation of Lotemax was statistically superior to placebo (vehicle gel) in eliminating inflammation and pain following cataract surgery by study-day eight. Consequently, the study met its primary endpoints.
The phase III study results showed that the new formulation is beneficial at a lower concentration and requires less frequent dosing than the current formulation. Upon approval, Lotemax 0.38% will be the first twice-daily ophthalmic steroid available.
We note that Lotemax 0.5% gel is indicated for the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis and selected infective conjunctivitides in the U.S.
Valeant also conducted a second phase III trial on Lotemax 0.38% gel in recently initiated post-operative cataract surgery patients. Valeant expects to file a New Drug Application (:NDA) with the FDA for sub-micron Lotemax 0.38% on the basis of data from these two studies in the second half of 2015.
We note that Valeant acquired Bausch + Lomb in Aug 2013 to strengthen its ophthalmology business, which was a miniscule portion of Valeant’s overall portfolio.
Valeant currently carries a Zacks Rank #5 (Strong Sell). Some better-ranked stocks in the broader health care sector include Johnson & Johnson (JNJ), Shire (SHPG) and Bristol-Myers Squibb (BMY). All three hold a Zacks Rank #2 (Buy).