By succeeding in a difficult head-to-head superiority trial against a market leader—a feat no competitor has achieved—Ocular believes it has entered a "separate orbit." The CEO argues the high bar of the trial will deter any other company from attempting a similar study, thus protecting their market position for decades without direct competition on this claim.
Ocular Therapeutix's trial prioritized a primary endpoint designed to satisfy FDA requirements for a superiority label—a key regulatory win. However, the CEO stresses that clinicians use different metrics like OCT fluid, where their drug "easily beat Eylea." This highlights a crucial strategy: separate the endpoint needed for approval from the data that drives physician adoption.
When questioned about higher ocular adverse events (53% vs 34%), the CEO explained the difference was primarily due to "floaters." This was an expected outcome as doctors were instructed to look for particles of the eluting drug. By clarifying this had no vision impact and wasn't a serious issue like inflammation, he effectively neutralized a potentially negative data point.
CEO Pravin Dugel anticipated the 27% stock drop following positive Phase 3 data, attributing it to the market's initial confusion over a new, complex study design. He believes that as investors digest the nuanced data showing superiority over a market leader, the valuation will correct, highlighting a common disconnect between biotech milestones and immediate market sentiment.