Novartis Discusses Ophthalmic Pipeline, $465M Encore Vision Deal in 2016 Annual Report

February 10, 2017: By Joan McKenna

novartis1Novartis has provided details of its ophthalmic pharmaceutical pipeline in its 2016 annual report and related material, released Jan. 25.

The Switzerland-based firm said it closed its acquisition of Encore Vision and Encore’s UNR844 technology for presbyopia on Jan. 20. Novartis paid $375 million up front, plus $90 million in early milestone payments, for a total of $465 million. Some industry analysts report that potential milestone payments could double the total.

A Phase II dose finding study of UNR844 is now in the planning stages, and the company has set a target of 2021 for filing for marketing approval.

UNR844, formerly EV06 ophthalmic solution (lipoic acid choline ester, 1.5%), is described as a prodrug to metabolize dihydrolipoic acid (DHLA). It is designed to improve flexibility in the crystalline lens through twice daily drops for six months, with the effects sustained for six months.

Retinal pipeline

RTH258: Novartis has been developing RTH258 (brolucizumab), an anti-VEGF agent, as a treatment for wet age-related macular degeneration (AMD). The firm said it plans to report the results of two Phase III trials in the first half of 2017 and file a marketing application with the US FDA in 2018. Novartis also will seek approval in the European Union and Japan. It said the single-chain antibody fragment may be longer acting than approved treatments for AMD.

Lucentis: Novartis said it continues to develop Lucentis (ranibizumab), an anti-VEGF agent that was originally approved for wet AMD. The company markets Lucentis outside the US. In 2016, Novartis received EU approval for the drug in visual impairment due to choroidal neovascularization associated with causes other than wet AMD or secondary pathologic myopia.

Lucentis is undergoing Phase II clinical study for retinopathy of prematurity, with an expected completion date of 2018. The company plans for file an application for the added indication in 2018.

Novartis said it is also exploring potential new therapies for glaucoma, dry eye, and other ocular conditions.

It is developing many biosimilars, including a Humira (adalimumab) biosimilar, with a planned filing for approval in 2017. AbbVie’s Humira, a rheumatoid arthritis treatment, is also indicated for uveitis.

Surgical pipeline

On the surgical side under its Alcon eye care division, Novartis plans to file for marketing approval of its Clareon next-generation monofocal IOL in 2017 in Europe and in 2019 in the US. It will seek US approval of its PanOptix trifocal and trifocal toric lenses in 2019. And the firm lists a mid-tier phacoemulsification device as being on track for commercialization in the US and EU in 2018.


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