Ocular Therapeutix (OCUL) RBC Capital Markets Virtual Ophthalmology Conference summary

Lead program and clinical trial updates

• Lead program AXPAXLI is in phase III, with the SOL-1 superiority study completed and showing a robust p-value of 0.0006, making it the first drug to show superiority over anti-VEGF in retina diseases.

• SOLAR, a phase III non-inferiority study, is ongoing and expected to read out in the first quarter of next year.

• SOL-1 results have been well received by the medical community, with strong recognition of the drug's disease control and durability.

• Strategic interest has increased following the successful superiority study, and further data presentations have clarified the results.

• The company plans to file for FDA approval based solely on SOL-1, citing strong confidence in the trial's design and outcome.

Clinical trial design and interpretation

• SOL-1 enrolled patients specifically selected to lose vision, making direct comparison to other studies inappropriate.

• The ceiling effect in patients with high baseline vision was observed, and AXPAXLI performed as well as Lucentis in similar historical studies.

• Real-world performance is expected to surpass clinical trial results due to the challenging patient selection in SOL-1.

• Doctors are expected to adopt flexible dosing strategies in practice, with enthusiasm for the drug's potential.

• The bar for success in terms of durability is considered low in real-world settings, supporting rapid adoption.

Safety and adverse events

• Floaters observed in 12% of the treatment arm were identified as drug particles, located in the periphery and not affecting vision.

• These floaters are expected to resolve naturally, with more data to be presented at an upcoming symposium.

• No safety issues have been observed with redosing in SOL-1 or in ongoing SOLAR monitoring.

• The company emphasizes transparent communication and data sharing regarding safety concerns.