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Find Clinical Drug Pipeline Developments & Deals by Alcon Inc
Alcon will add Rocklatan (netarsudil and latanoprost ophthalmic solution) and Rhopressa (netarsudil ophthalmic solution), as well as AR-15512, a Phase 3 candidate for dry eye disease, and a pipeline of several clinical and preclinical ophthalmic pharmaceutical candidates.
Through the transaction, Alcon has added the commercial products Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% and Rhopressa (netarsudil ophthalmic solution) 0.02%, as well as AR-15512, a Phase 3 product candidate for dry eye disease.
Alcon will add Rocklatan (netarsudil and latanoprost ophthalmic solution) and Rhopressa (netarsudil ophthalmic solution), as well as AR-15512, a Phase 3 candidate for dry eye disease, and a pipeline of several clinical and preclinical ophthalmic pharmaceutical candidates.
AR-15512 is a first-in-class TRPM8 agonist which acts as a cold thermoreceptor modulator to stimulate the cold sensing receptors found on the nerve endings that innervate the cornea and eyelids.
AR-15512 (AVX012), is a first-in-class TRPM8 agonist which acts as a cold thermoreceptor modulator to stimulate the cold sensing receptors found on the nerve endings that innervate the cornea and eyelids.
The acquisition will complement Alcon’s existing portfolio in the large and fast-growing dry eye category. EYSUVIS (Loteprednol Etabonate) will complement the Systane® family of eye drops which includes the recently launched Systane Preservative-Free formulations.
Rocklatan (netarsudil and latanoprost), indicated for reduction of elevated IOP in patients with glaucoma or ocular hypertension, demonstrated consistent IOP reduction of ~9.5 mmHg and an average IOP reduction of 37% from baseline in European Phase 3B clinical trial.
Santen will be responsible for all development and commercialization costs and activities related to the products in the territories covered by the agreement with the exception of a post-marketing clinical study to be conducted by Aerie in Europe for Rhopressa and Rocklatan.
Netarsudil 0.02% is known by the name Rhokiinsa® in the European Union, where it is approved for the reduction of elevated IOP in adult patients with primary open-angle glaucoma or ocular hypertension.
Both formulations of AR-15512 were safe and well-tolerated. Ninety five percent of adverse events were mild with less than 3 percent of subjects discontinued due to adverse events.