Alcon settles Wavelight takeover, amends nasal spray NDA

Huenenberg, Switzerland-The Alcon Inc. public takeover offer period for WaveLight AG ended in mid-October.

The transaction will be settled after cartel clearance in China and Cyprus, at which time Alcon will have control of 77.4% of the approximately 6.6 million outstanding WaveLight shares. The company previously received cartel clearances from Germany, Austria, and Spain.

“I am very pleased with this result,” said Cary Rayment, Alcon president, chairman, and chief executive officer. “It enables us to integrate WaveLight operations with Alcon’s global capabilities and create a leading force in the refractive laser market.”

Under the takeover offer, 3.1 million (47.5%) of outstanding WaveLight shares were tendered to Alcon. Alcon had also purchased 2 million (29.9%) WaveLight shares in the market or directly.

In other news, Alcon submitted to the FDA an amendment to its pending new drug application (NDA) for olopatadine HCl (Patanase) nasal spray. The pending NDA is for the treatment of symptoms of seasonal allergic rhinitis in adults and adolescents aged at least 12 years. The amendment includes interim 6-month data from an agreed-on study previously requested by the FDA to support a modification of the formulation of the nasal spray.

“I am happy to see that [olopatadine] is moving forward to FDA review because I believe it will provide an attractive treatment option for patients with seasonal allergic rhinitis,” said Rohit K. Katial, MD, a principal investigator for olopatadine and associate professor of medicine at National Jewish Medical and Research Center, Denver. “Data collected through multiple studies that make up the current NDA demonstrate that [olopatadine] provides rapid relief from bothersome nasal allergy symptoms.”

Olopatadine, the active ingredient in the nasal spray, is the same one used in two of the company’s drops for ocular allergies (Pataday, Patanol).

Kevin Buehler, Alcon’s senior vice president, global markets, and chief marketing officer, said, “We will provide the FDA with additional data during [its] review of our amended NDA, including the final results of the requested study.”