Auven Therapeutics said today it will sell its Ocular Technologies subsidiary—whose key asset is the Phase III dry eye disease treatment candidate SecieraTM (OTX-101)—to Sun Pharma for $40 million upfront, plus undisclosed milestone payments and royalties.
Seciera is Auven’s novel nanoscale micelle formulation of cyclosporine. Micelles containing the active compound are composed entirely of inert materials and are on average less than 25 nm in diameter.
Seciera is under study in a pivotal trial designed to confirm the significant, clinically meaningful increase in the signs of dry eye disease exhibited in a previous Phase IIb/III study. Enrollment has been completed with 747 patients in the randomized, double-blind, placebo-controlled Phase III trial. Auven said top-line results are expected in the first quarter of 2017.
“Seciera has the potential to be a best-in-class product and the first treatment for dry eye disease that addresses both tear production and inflammation of the ocular surface,” Peter B. Corr, Ph.D., an Auven co-founder and managing general partner. “In addition, Seciera offers key improvements in earlier onset of positive effects and lack of application discomfort over currently available therapies.”
Seciera showed statistical superiority over placebo for the co-primary efficacy endpoint of change from baseline at week 12 in conjunctival lissamine green staining, in a prior trial. The 455-patient study also showed promising results for the compound in analyses of tear production and fluorescein corneal staining.
Sun Pharma agreed to acquire all of Ocular Technologies for $40 milion upfront as well as payments tied to achieving development and sales milestones, and tiered royalties on global sales of Seciera.
The deal is expected to close before year’s end, subject to conditions that include expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Act.
“We believe that the Sun Pharma team has the ophthalmology expertise, the corporate focus and the commercial resources to launch Seciera aggressively in the U.S. and major global markets,” added Stephen Evands-Freke, another Auven co-founder and managing general partner.