Biotech Values

[DewDiligence]

Lucentis post-mortem:

Kudos to masterlongevity for stating on this board that Lucentis would be approved with a broad, unrestricted label and no significant safety issues.

Broad: the indication is for treatment of wet AMD without regard to the lesion subtype, size, or prior therapies used, and it permits—even advises—clinicians to experiment with individualized dosing schedules.

Unrestricted: the label does not preclude treatment of AMD patients with poor cardiovascular health or other pre-existing medical conditions.

Safety: by approving the higher of the two doses tested in the phase-3 trials (0.5mg), the FDA has signaled that they see no material safety issues. The label even uses the word theoretical to describe the potential risk from the minuscule amount of Lucentis that escapes from the vitreal chamber and passes into general circulation, which implies that the Agency is not convinced that there is any such risk.

All told, I think it’s fair to say that Lucentis has among the best benefit-to-risk tradeoffs of any drug approved in recent memory. DNA basically got everything they were hoping for.