Shire's (LON:SHP) lifitegrast is likely to have a strong foothold on the dry eye market but will not displace Allergan's (NYSE:AGN) Restasis (cyclosporine ophthalmic emulsion), experts noted.
There are a variety of patients groups not served by Restasis or not completely benefiting from the drug, they explained. The two drugs work differently and thus both have a place on the market, experts noted. Given the different MOAs, they also pointed to the synergistic potential of using both drugs together.
Lifitegrast's PDUFA date is 22 July. OPUS-3 is the third pivotal trial for lifitegrast submitted to the FDA as part of an NDA re-submission to address the Complete Response Letter Shire received on 16 October 2015. The FDA declined to approve the drug based on its earlier OPUS-1 and OPUS-2 trials.
Shire's lifitegrast program is encouraging and approval could be eased by an evolving regulatory process, this news service previously reported.
The FDA will evaluate the lifitegrast application based on the totality of the data across all studies including OPUS 1, 2, 3 and its one-year safety study, SONATA, a spokesperson said.
Expected US peak sales for lifitegrast are USD 1bn in 2022, according to an analyst report. US sales for Restasis are expected to reach USD 2.55bn in 2024, based on an analyst report.