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| Statement |
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| This remains an incredibly exciting time for EyePoint as we are well positioned to execute on our upcoming milestones and continue to transform the treatment landscape with innovative long-term solutions to improve both the vision and the lives of patients with serious retinal diseases |
| By preventing or at least delaying significantly the advancement of to those site threatening complications, using EYP-1901 potentially once every 9 months approximately, we think we can really improve patients' lives by preventing visual loss and preventing the eventual need for multiple injections over years |
| The impressive execution and dedication demonstrated by our team to reach these milestones reflects the entire organization's commitment to patients |
| As we've discussed, EyePoint is a story of execution and positive data |
| In conclusion, we are pleased with EyePoint's progress in 2023 and are well capitalized to advance our product pipeline to key value inflection points |
| Before we review the financial results, 2023 was an exceptional year for our financial performance |
| With our compelling clinical pipeline representing potential multi-billion-dollar product opportunities, our best-in-class sustained ocular delivery to research e-technology, along with a strong balance sheet, we're well positioned to grow as a leader in ocular drug delivery and to bring impactful therapies to patients suffering from serious retinal diseases |
| And therefore, we're optimistic in, I'd say, going into the end of Phase 2 meeting confident about most of the large touch points around our pivotal trial design |
| We also significantly strengthened our balance sheet, ending 2023 with $331 million in cash and investments and no debt |
| 2023 was truly an exceptional year for EyePoint Pharmaceuticals on all fronts |
| Second, the strong and very convincing results from DAVIO 2 |
| Again, the data from DAVIO 2 was excellent |
| And we're confident that his proven leadership and strong scientific and clinical background will be a tremendous asset to the EyePoint team |
| We remain highly encouraged by the growing body of positive clinical data for EYP-1901, and we are optimistic that EYP-1901 is the potential to change the current treatment paradigm for VEGF-mediated retinal diseases |
| Using it as a drug delivery also shows promise, especially for chronic diseases |
| Consistent with our results to date for this program, we expect to see a continued favorable safety profile, a critical factor in any retinal drug |
| So gene therapy is certainly an exciting advance in the retina field, and as a replacement for a faulty gene, it's obviously been approved in that indication and really has been an incredible benefit to patients |
| This result confirms that the positive top line data from the Phase 2 DAVIO 2 trial were driven by EYP-1901 and not by supplemental injections |
| I can say, again, in a rather qualitative way, the initial interactions we have with the payers are quite positive |
| In addition to the positive safety and efficacy data reported to date, vorolanib has also demonstrated neuroprotection in a validated retinal detachment animal model |
| So I think our message in our great data is getting out there, and I think it will continue to be well received in both those communities |
| We've accomplished our clinical milestones efficiently and on track with our guidance and we plan to continue this track record in 2024 and beyond |
| We also saw an over 80% reduction in treatment burden, measured both prospectively and retrospectively, with strong anatomical control in both EYP-1901 cohorts |
| This could represent a significant improvement compared to the current anti-VEGF treatments that are dosed on average every two months in the United States, and this may allow patients and practitioners the flexibility to reduce the number of visits without sacrificing visual outcomes |
| In December, we reported positive top-line efficacy and safety data from our Phase 2 DAVIO 2 clinical trials in wet AMD, achieving all primary and secondary endpoints |
| There remains a great unmet need for a safe, efficacious, and convenient treatment for NPDR that proactively reduces the risk of progressing to site-threatening complications over the long-term |
| And lastly, the retina community is very small, and EyePoint has a reputation of being a strong scientific company and always puts patients in the first place |
| So at a high level, I think all retina specialists are excited about the promise of gene therapy |
| Importantly, EYP-1901 continued to demonstrate a favorable safety profile with no EYP-1901 related ocular or systemic serious adverse events, or SAEs, reported |
| The decision to use one versus two inserts in the Phase 3 trials is driven by the positive DAVIO 2 data for both the 2 milligram and the 3 milligram doses |
| Statement |
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| This decrease in net product revenue resulted from our strategic exit from the commercial business in the first half of 2023, highlighted by the out license of YUTIQ in May |
| We have some other questions around some inclusion, exclusion criteria, which we may hopefully be made clear in the meeting and also some issues around the safety cohort that we need to show the FDA |
| This decrease was primarily driven by the strategic exit from the commercial business in the first half of 2023 and a one-time intangible asset impairment charge in the fourth quarter of 2022 |
| Net non-operating expense totaled $4.4 million and net loss was $70.8 million or $1.82 per share compared to a net loss of $102.3 million or $2.74 per share for the prior year period |
| Without you all, the progress we've made advancing EYP-1901 would not be possible |
| Non-operating income totaled $2.3 million and net loss was $14.1 million or $0.33 per share loss compared to a net loss of $43.5 million or $1.16 per share loss for the prior year period |
| Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent annual report on Form 10-K, which is on file with the SEC and in other filings that we may make with the SEC in the future |
| It's important to note that this is a lower limit and not an expectation |
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