Regeneron Shares Flat as Axpaxli Shows 18.3%-21.7% Visual Acuity Edge
Phase 3 SOL-1 trial data showed Axpaxli maintained visual acuity in 74.1% of patients at 36 weeks versus 55.8% for Regeneron’s Eylea, and 65.9% versus 44.2% at 52 weeks (p<0.0001). Despite Eylea’s stronger-than-expected control arm performance and no serious safety issues, Regeneron shares held flat.
1. SOL-1 Trial Efficacy Results
The Phase 3 SOL-1 superiority trial enrolled wet AMD patients to compare Axpaxli against Regeneron’s Eylea. At 36 weeks, 74.1% of Axpaxli patients maintained visual acuity compared to 55.8% for Eylea, an 18.3% difference (p=0.0006). At 52 weeks, the gap widened to 21.7%, with 65.9% versus 44.2% (p<0.0001).
2. Safety Profile Comparison
No treatment-related ocular or systemic serious adverse events were reported for Axpaxli or Eylea. However, Axpaxli patients experienced higher rates of vitreous floaters (12.4% vs. 1.2%) and cataracts (7.1% vs. 2.9%) compared to the Eylea control arm.
3. Market Reaction and Stock Movement
Ocular Therapeutix shares plunged 25% on result release, while Regeneron shares remained unchanged. Investors cited the unexpectedly strong Eylea control arm and a smaller-than-anticipated efficacy margin as reasons for caution despite positive statistical outcomes.
4. Analyst Perspectives
TD Cowen highlighted the impressive best-corrected visual acuity consistency in rescue-free patients, while Needham noted potential durability questions versus Eylea HD and Vabysmo. RBC opined that the SOL-1 data should benefit Ocular Therapeutix long term but acknowledged initial investor disappointment over the high control arm response.