In this exclusive MedPage Today video, Dr. David Eichenbaum, the director of research for Retina Vitreous Associates of Florida in Saint Petersburg, elaborates on the critical importance of the ongoing phase III studies in retinal therapy.
Following is a transcript of his remarks:
The current treatment protocols predominantly utilize anti-VEGF agents, which efficiently target extracellular VEGF to inhibit neovascularization. While these therapies have demonstrated efficacy over the years, their considerable limitations regarding the frequency of required dosing pose challenges for both patients and clinicians.
In contrast, tyrosine kinase inhibitors, such as OTX-TKI, operate through a distinct mechanism. They specifically target intracellular processes downstream of the VEGF receptor, presenting a valuable alternative approach to mitigating VEGF signaling. This strategy is differentiated from established extracellular treatments, including currently available injections and numerous investigational products in various stages of development.
Remarkably, clinical data indicate a nearly 90% reduction in the injection burden for patients receiving OTX-TKI compared to those treated with aflibercept 2 mg. This substantial decrease in treatment frequency heralds a potential shift in the management of retinal diseases.
Furthermore, the safety profile of OTX-TKI is noteworthy, exhibiting favorable outcomes comparable to both aflibercept and other intravitreal therapies. Importantly, the primary aim of phase I studies is to rigorously assess safety, and initial pharmacodynamic evaluations suggest that OTX-TKI might provide durable therapeutic effects for an impressive duration of 9 to 12 months following administration.
Currently, there are two pivotal trials within the phase III program investigating the efficacy of the OTX-TKI axitinib intraocular insert. The first trial, the SOL-1 study, is designed to evaluate the durability of response over a 36-week period, benchmarking it against aflibercept 2 mg. Conversely, the second trial, SOL-R, focuses on repeated dosing of the OTX-TKI intraocular insert. The data generated from these trials are critical for regulatory approvals, potentially paving the way for OTX-TKI’s introduction into clinical practice. This advancement may significantly lessen the treatment burden experienced by patients suffering from common retinal diseases, aligned with the encouraging results seen in the phase I study.
Should OTX-TKI receive approval and prove successful in the SOL-1 and SOL-R trials, demonstrating durability and safety with repeated dosing, patients may benefit from treatment outcomes comparable to those achieved with the current regime of frequent intravitreal injections—yet with significantly reduced treatment intervals. Physicians could realize similar therapeutic efficacy without the necessity for the frequent injections that are currently standard practice, all while maintaining a safety profile in line with existing available therapies. This prospect is genuinely exciting.
The retina community is increasingly advocating for a reduction in treatment burden. The innovative combination of tyrosine kinase technology and polymeric delivery systems utilized in the OTX-TKI product represents a promising avenue toward achieving this much-desired goal.
**Interview with Dr. David Eichenbaum on OTX-TKI and the Future of Retinal Therapy**
**Interviewer:** Thank you for joining us today, Dr. Eichenbaum. As the director of research at Retina Vitreous Associates of Florida, you have been following the developments in retinal therapies closely. Can you tell us about the significance of the ongoing phase III studies for OTX-TKI?
**Dr. Eichenbaum:** Thank you for having me. The ongoing phase III studies for OTX-TKI are indeed critical. They represent a potential turning point in how we manage retinal diseases, especially wet age-related macular degeneration (AMD). The pivotal studies will help determine the efficacy, durability, and safety of this new treatment compared to existing therapies.
**Interviewer:** What sets OTX-TKI apart from traditional anti-VEGF treatments?
**Dr. Eichenbaum:** OTX-TKI employs a unique mechanism by targeting intracellular processes downstream of the VEGF receptor, rather than solely inhibiting extracellular VEGF as traditional anti-VEGF agents do. This allows for greater modulation of the VEGF pathway and may lead to more sustained therapeutic effects.
**Interviewer:** You mentioned the impressive reduction in the treatment burden for patients. Can you elaborate on that?
**Dr. Eichenbaum:** Absolutely. Clinical data suggests that patients receiving OTX-TKI could experience a nearly 90% reduction in injection frequency compared to those on aflibercept. This significant decrease could alleviate the physical and psychological burden that frequent treatments can impose on patients.
**Interviewer:** That sounds promising. What do the initial safety assessments indicate about OTX-TKI?
**Dr. Eichenbaum:** The safety profile of OTX-TKI looks favorable, showing outcomes comparable to aflibercept and other intravitreal therapies. Initial pharmacodynamic evaluations suggest that patients may benefit from therapeutic effects lasting between nine and twelve months post-administration, which is quite remarkable.
**Interviewer:** With two pivotal trials currently underway, what are the specific objectives of the SOL-1 and SOL-R studies?
**Dr. Eichenbaum:** The SOL-1 study aims to evaluate the durability of the OTX-TKI response over a 36-week period, comparing it to aflibercept. On the other hand, the SOL-R study focuses on the implications of repeated dosing with the OTX-TKI intraocular insert. The outcomes from these trials are fundamental for regulatory approvals, and they could significantly change our clinical practice in managing retinal diseases.
**Interviewer:** Lastly, if the trials prove successful, what impact do you foresee on the treatment landscape for patients with retinal diseases?
**Dr. Eichenbaum:** If OTX-TKI gains approval based on these studies, it could fundamentally reshape treatment protocols by reducing the need for frequent injections. This would not only improve patient quality of life but also enhance treatment adherence, leading to better overall outcomes for individuals suffering from retinal conditions.
**Interviewer:** Thank you for your insights, Dr. Eichenbaum. We look forward to seeing the results of these trials and the advancements they may bring to retinal therapy.
**Dr. Eichenbaum:** Thank you. It’s an exciting time for the field, and these developments hold great promise for our patients.
