OCULAR THERAPEUTIX, INC Q3 FY2024 earnings call

Pravin Dugel discussed that SOL-1 has reached a key enrollment milestone, with full randomization projected by year-end 2024, well ahead of prior guidance. Active study sites can now enroll patients directly into SOL-R, the second registrational trial for AXPAXLI in wet AMD. The trials SOL-1 and SOL-R are thoughtfully designed to complement each other, with SOL-1 focusing on durability and SOL-R on repeatability. AXPAXLI's potential in wet AMD includes strong trial results and positive data in diabetic retinopathy from the HELIOS trial. The commercial team is prepared for a potential launch of AXPAXLI, leveraging experience with DEXTENZA.

Expects SOL-1 to complete randomization by year-end 2024 with top-line data in Q4 2025. SOL-R enrollment is accelerated by the transition from SOL-1. Confident in AXPAXLI's potential based on trial results and clinical demand. Cash and cash equivalents of ~$427 million at end of Q3 provide runway into 2028 and fund SOL-1 and SOL-R to top-line results.

Q: Talk about how many sites for SOL-1 and SOL-R are overlapping and if additional sites are planned for SOL-R.

A: Pravin Dugel says there are overlapping sites by design, no slowdown in enrollment, and they are continuing to activate other sites for SOL-R.

Q: Define what a differentiated product label for AXPAXLI would be.

A: Pravin Dugel explains it would include durability from SOL-1, repeatability from SOL-R, and potentially a superiority label, providing regulatory and commercial advantages if approved.

Q: Update on SOL-R enrollment progress and expectations.

A: Pravin Dugel says updates will be provided, with seamless transition from SOL-1 to SOL-R accelerating SOL-R enrollment.

Q: Progress of EMA discussion and patient population for AXPAXLI in wet AMD.

A: Pravin Dugel mentions ongoing EMA discussions and de-risked patient populations in the trials.

Q: Commercial efforts and pricing for AXPAXLI.

A: Steve Meyers talks about DEXTENZA hitting guidance and CMS rule confirming separate payments in HOPD. Pravin Dugel notes focus on premium pricing but no specific details yet.

Q: Next trial for diabetic retinopathy and endpoints.

A: Pravin Dugel discusses HELIOS trial results and future plans for diabetic retinopathy, pending FDA feedback on endpoints.

Q: Regulatory submission for wet AMD, rolling submission.

A: Pravin Dugel says need for two positive studies historically, in close collaboration with FDA for wet AMD submission