Ocular Therapeutix, Inc. Q1 FY2026 earnings call

2026 is off to a great start for Ocular Therapeutics. Xpaxly showed superiority to an approved anti-VEGF agent in a phase three wet AMD trial (SOL1) with a p-value of 0.0006 for the primary endpoint. It had unmatched durability, sustained disease control with fewer rescues, and 66% of patients had a single injection maintain vision for a year. Initiated enrollment in Solex long-term extension trial. Completed randomization of 631 subjects in SOLAR, exceeding the target, and accelerated guidance for SOL-R top-line data to first quarter 2027. Initiated enrollment in SOLEX open-label long-term extension study. Helios 3 trial in diabetic retinopathy ongoing. Plan to host investor day on June 17th with updates. Ended first quarter with $667 million in cash.

Accelerated guidance for SOL-R top-line data to first quarter of 2027. Remain on track to submit NDA relying on SOL1 Week 52 data, subject to ongoing formal discussions with the FDA.

Q: Fazeen Ahmed with Bank of America asked about discussions with FDA and timeline differences between applying with SO1 vs waiting for SOLAR.

A: Praveen Dougal said ongoing formal discussions with FDA, aligned with FDA's goals, SOL1 checks all boxes, SOLAR enrollment is efficient with no change in its progress.

Q: Piper Sandler's Barron asked about pre-NDA meetings with FDA and patient discontinuations/retention in SOL-R.

A: Praveen said not disclosing FDA meeting details, SOL-R has phenomenal retention rate like SOL-1.

Q: Tara Bancroft with TD Cowan asked about process ahead of filing and timing of SOL-X data.

A: Praveen said aligned with FDA's goals, SOL-X will provide long-term effectiveness data, details in June Investor Day.

Q: Sean McCutcheon with Raymond James asked about optionality of adding SOAR to safety database and risk of unmasking SOAR.

A: Praveen said no change to SOLAR, flexibility in safety database with SOLAR and Helios study.

Q: Lisa Walter with RBC Capital Markets asked about secondary endpoints in SOLAR and injection burden measurement.

A: Lisa said details in June Investor Day.

Q: John Wallenbehn with Citizens asked about feedback on integrating Xpaxly in practice and fixed dosing.

A: Praveen said Xpaxly will likely lead to fixed dosing, transforming wet AMD treatment, adoptability seamless.

Q: Yin Chin with HC Wainwright asked about patients dropping out of SO1 and enrolling in SOX.

A: Praveen said retention rate in SO1 is remarkable, enthusiasm is high.

Q: Lachlan Hanbury-Brown's Truman Dunkley asked about Helios 3 study and data for DME label.

A: Praveen said no specific proportion requirement, confident Helios 3 will cover broad label for diabetic retinopathy