Outlook Therapeutics Inc (OTLK)

[VMLG17]

Any comments on the implications re: https://www.biopharmadive.com/news/roche-vabysmo-eylea-amd-sales-first-quarter/648679/

People with wet age-related macular degeneration must take frequent eye injections of biologic drugs like Lucentis and Eylea to slow the vision loss they experience. Drugmakers have sought to reduce the frequency of those injections to help patients as well as ophthalmologists seeking to free up staff and office resources. Meanwhile, insurers — primarily Medicare in the U.S. — have been looking to reduce the costs of paying for physician services.

The Food and Drug Administration recommends injecting Lucentis once a month, although patients can go with less frequent appointments if they’re willing to sacrifice some efficacy. Eylea, on the other hand, has similar effectiveness when taken every eight weeks after an initial dosing period of once every four weeks.

Vabysmo reduced dosing even further, to once every four months. Its annual list price of $6,570 during that maintenance phase, or $2,190 a shot, is competitive with Lucentis biosimilars, which cost around $1,000 a shot. Eylea biosimilars are expected to enter sometime this year or next.

Vabysmo’s strong launch puts pressure on Regeneron, which relies on Eylea for a bulk of its sales. But Regeneron aims to soon win U.S. approval of a high-dose version that could blunt competition.

Analysts at RBC Capital Markets expect Vabsymo’s market share to grow, but wrote in a note to clients that “the window of opportunity for Vabysmo to make significant competitive inroads to Eylea franchise may be narrowing” with the high-dose Eylea formulation coming.