Approval UncertaintyThe probability of success for Reproxalap has been decreased from 85% to 75%, reflecting increased uncertainty in the approval process.
Investor SkepticismInvestors are skeptical of the approval of reproxalap in dry eye disease based solely on a positive resubmission chamber trial, as the stock is down.
Regulatory ChallengesThe FDA has delayed the approval of Reproxalap due to concerns over trial results, which has pushed the expected drug launch out by a year.