Aug. 20 at 5:19 PM
$HROW Why This Is a Structural Game-ChangerDefinitive Clinical Proof for Retina Specialists:
Until now, retina uptake has grown primarily through real-world physician word-of-mouth (driving Q2 unit demand up +100% YoY in retina). Having randomized, within-patient data demonstrating a 58% reduction in post-injection pain gives Harrow's field sales force a marketing tool that standard generic eye drops cannot match. De-risking the Phase 4 QUELL Trial (Q4 2026):
Harrow's larger registration trial, QUELL (~236 patients) under an active IND, is scheduled to read out topline results in Q4 2026. Today's
$P \sim 0.001$ readout in a 100-eye randomized setting strongly suggests that QUELL will hit its primary endpoints. The FDA Label Expansion Pathway:A successful QUELL readout in Q4 allows Harrow to submit a supplemental New Drug Application (sNDA) to place IHEEZO formally on-label for intravitreal retina injections, eliminating any institutional hesitation among high-volume surgical networks
