OCULAR THERAPEUTIX, INC Q2 FY2025 earnings call

• Corporate branding updated to reflect the company's focus as a retina-focused innovator. • AXPAXLI's registrational program for wet AMD includes SOL-1 (superiority trial) and SOL-R (non-inferiority trial). SOL-1 has 344 patients randomized, on track for top-line data in Q1 2026. • Plans to incorporate a long-term open-label extension study for both SOL trials to generate real-world insights. • SOL-R enrollment complete, expects top-line data in H1 2027, with rescue criteria streamlined to greater than 5 letter loss + ≥75-micron increase in central subfield thickness. • Preparing to expand into nonproliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME) with positive FDA feedback on trial design. • Well-capitalized with over $390 million in cash and expected runway into 2028.

No specific financial performance details for product segments provided in the transcript.

• Plan to submit NDA for AXPAXLI shortly after SOL-R 56-week primary endpoint. • Leverage 505(b)(2) NDA review pathway to potentially shorten review timeline by 2 months. • Upcoming Investor Day on September 30 to provide deeper insights into SOL trials, extension study, diabetic eye disease strategy, and global commercial vision.

No specific risks discussed in detail during the call; general mention of risk factors in SEC filings noted.

Q: When do you expect to complete randomization of the 555 patients required for SOL-R? What drove the change in rescue criteria for SOL-R? And was there anything on a mass basis that drove the change?

A: Pravin U. Dugel stated randomization update would be provided when appropriate, change in rescue criteria was a strategic decision based on confidence in SOL-1 mass data and to align with clinical relevance, not FDA required.

Q: How are you thinking about potential shortened review timeline for AXPAXLI filing after SOL-R reads out? When should we think about pace for preparing launch?

A: Pravin U. Dugel mentioned FDA wants 2 well-controlled, well-masked positive studies, plan to submit NDA after SOL-R, and details on launch preparation to be outlined at Investor Day.

Q: Clarify impact of updated rescue criteria on FDA evaluation of SOL-R primary endpoint and whether it delays primary endpoint readout?

A: Pravin U. Dugel stated no change in FDA evaluation of primary endpoint, change in rescue criteria doesn't delay primary endpoint readout.

Q: Rationale and purpose of single long-term extension study for both trials? Commercial bar for AXPAXLI to gain dominant position?

A: Extension study to generate long-term data for superiority label and clinical advantage; commercial bar involves showing data that allows physicians to translate study results to patient treatment.

Q: Impact of 12-month follow-up for SOL-1 on SOL-R and visibility into patient redosing?

A: Pravin U. Dugel stated they will provide data to show translation from SOL-1 to SOL-R.

Q: Clarify off-protocol rescues in SOL-1?

A: Pravin U. Dugel explained rescues per doctor's discretion for patient protection, vast majority of rescues align with protocol.

Q: Remind of SOL-R rescue criteria before change and impact on number of rescues? Comment on real-world practice change?

A: Change in rescue criteria was strategic, no FDA issue, reflects confidence in drug and allows for immediate adoption.

Q: Feedback prompting change in rescue criteria and expectation for cadence of rescues in SOL-1?

A: Feedback was to align with investor and clinical relevance, cadence of rescues in SOL-1 is as expected.

Q: Interplay of AXPAXLI's time to market with potential superior label vs competitors?

A: Superiority label provides a distinct position, immunizing from downstream pressures and allowing better patient care.

Q: Reason for starting open-label extensions now vs previously?

A: Logistic reason, with more detail to be outlined at Investor Day.

Q: Impact of excluding patients with high OCT fluctuations on commercial effort?

A: Excluding such patients provides more valid scientific data, no restrictive label impact.

Q: Interplay of SOL-1 data readout on SOL-R, derisking or complementary?

A: Both, with patient selection and trial design providing confidence in translation, but will address SOL-1 positive results to translate to SOL-R success.