Valeant Pharmaceuticals Intl Inc’s (VRX) Bausch + Lomb Announces PDUFA Date for Luminesse

Valeant Pharmaceuticals Intl Inc (NYSE:VRX) wholly owned subsidiary, Bausch + Lomb, announced that the FDA accepted the New Drug Application (NDA) for brimonidine tartrate ophthalmic solution, 0.025% (Luminesse™*), and set a PDUFA action date of December 27, 2017. Luminesse is a topical vasoconstrictor formulation to be used Over-the-Counter (OTC) as an eye drop to relieve redness of the eye due to minor eye irritations. If approved, this will be the first OTC product developed with brimonidine tartrate for the treatment of ocular redness.

“The filing acceptance of Luminesse brings us one step closer to bringing a new treatment option to potentially help patients in the more than 14 million households who use OTC eye drops to treat ocular redness,” said Joseph C. Papa, Chairman and CEO of Valeant. “If approved, Luminesse may provide patients with ocular redness significant benefits versus other competing redness reliever products currently available.”

Six clinical studies were conducted to evaluate the safety and effectiveness of low-dose Luminesse in relieving ocular redness, including a study to demonstrate the absence of IOP-lowering potential of low-dose brimonidine. Bausch + Lomb also conducted a comprehensive review of all post-marketing safety data, as the active ingredient brimonidine tartrate is typically found to be used in prescription ophthalmic products. The drug was found to be highly efficacious and safe with low risk of tachyphylaxis (tolerance or loss of effectiveness) and rebound congestion, which are both common to currently available OTC redness reliever eye drops.

Shares of Valeant closed today at $9.71, down $0.36 or -3.57%. VRX has a 1-year high of $32.75 and a 1-year low of $8.31. The stock’s 50-day moving average is $9.89 and its 200-day moving average is $14.21.

On the ratings front, Valeant has been the subject of a number of recent research reports. In a report released today, Canaccord analyst Neil Maruoka reiterated a Hold rating on VRX, with a price target of $12.00, which represents a potential upside of 24% from where the stock is currently trading. Separately, on May 5, Jefferies’ David Steinberg reiterated a Buy rating on the stock and has a price target of $18.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Neil Maruoka and David Steinberg have a yearly average loss of 1.8% and a return of 1.1% respectively. Maruoka has a success rate of 41% and is ranked #3871 out of 4568 analysts, while Steinberg has a success rate of 49% and is ranked #2065.

Overall, 3 research analysts have rated the stock with a Sell rating, 9 research analysts have assigned a Hold rating and 2 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $14.33 which is 48% above where the stock opened today.

Valeant Pharmaceuticals International, Inc. engages in the development, manufacture, and market of a broad range of pharmaceutical products in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. It operates through the following segments: The Bausch + Lomb/International, The Branded Rx, and The U.S. Diversified products. 


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