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In Brief | Ophthalmology | Glaucoma | Novel Therapeutic
Novel Ocular Implant for Glaucoma Treatment Shows Promising Results
Time to read: 05:03
Time to listen: 09:35
Originally Published: 11 November 2024
Type of article: In Brief
MedED Catalogue Reference: MNIB009
Category: Neurology
Cross Reference: Gerontology
Keywords: dementia, frailty, gerontology, burden of disease, Alzheimer's
The Phase 2a trial of PA5108, a novel glaucoma treatment implant, demonstrated statistically significant reductions in intraocular pressure, with 94% of participants not requiring additional IOP-lowering eye drops. The implant was well-tolerated, with no evidence of inflammation or corneal endothelial cell changes, and its sustained drug delivery showed clinically meaningful effects.
This article is a review of recent studies originally published in OphthalmologyTimes, 3 December 2024 and Brandon Byocatalyst, 31 Nov 2024 . It does not represent the original research, nor is it intended to replace the original research. Access the full Disclaimer Information.
Glaucoma treatments traditionally rely on patient-administered eye drops, but adherence to this regimen is often poor, with 40-90% of patients failing to follow the treatment correctly within a year.
To combat this, PolyActiva, an innovative ophthalmology company, has announced promising results from its Phase 2 clinical trial of PA5108, a novel glaucoma treatment implant.
The findings were presented at the Eyecelerator conference in conjunction with the American Academy of Ophthalmology’s annual meeting in Chicago on October 17, 2024, and at AusBiotechInvest in Melbourne, Australia, on October 29, 2024.
PolyActiva’s proprietary implant aims to resolve the issue of poor adherence to eye drop therapy by providing sustained, accurate drug delivery over an extended period. Constructed from a biodegradable polymer, the implant ensures precise dosing and, unlike other treatments, degrades rapidly once the drug is released, allowing for repeat dosing and potentially reducing the risk of glaucoma progression and blindness.
This study reviews the findings of the Phase 2a study.
Study Purpose
This study aimed to evaluate the efficacy and safety of PA5108, a biodegradable ocular implant designed to provide sustained drug delivery to glaucoma patients, potentially addressing issues of poor patient adherence to traditional eye drop therapy.
Study Methodology
This study is a multi-centre, open-label, Phase 2a trial designed to find the safest and most effective dose of the PA5108 Latanoprost FA SR Ocular Implant (14.7 to 35.5 micrograms) in adults with Primary Open Angle Glaucoma (POAG).
The goal was to determine the minimum dose that reduces intraocular pressure (IOP) by at least 20% after 12 weeks with minimal side effects.
The study included three single-dose groups (14.7 mcg, 26.6 mcg, and 35.5 mcg) and one repeat-dose group (14.7 mcg).
Participants who had previously been using IOP-lowering drops underwent a washout period before receiving the implant.
The implant was injected into one eye, and IOP was monitored. In the repeat-dose group, participants received a second dose at Week 21.
Participants were followed up at Day 1, Week 6, 12, 18, and then every 6 weeks, to monitor IOP and confirm the implant biodegraded.
The study concluded after 48 weeks, or when the implant biodegraded and IOP returned to normal.
Findings
The trial successfully met its efficacy and safety endpoints, marking significant progress toward providing long-term, reliable drug delivery for glaucoma patients.
Seventeen participants received two PA5108 Ocular Implants, 21 weeks apart, and fifteen have completed 48 weeks of the study.
Key findings include:
Statistically significant reductions in IOP at Weeks 12, 21, 33, and 42 (p<0.0001).
Clinically meaningful IOP reductions at 8 AM over 48 weeks, with reductions ranging from 26% to 35%.
94% of participants did not require additional IOP-lowering eye drops during the 48 weeks.
A greater than 20% reduction in IOP was maintained even after the second implant was administered, with clinically significant effects lasting for 26 weeks after the second implant.
No evidence of inflammation or corneal endothelial cell changes, with only one instance requiring rescue medication.
Discussion
The results from the PA5108 clinical trial indicate that this novel glaucoma implant could significantly address the challenges faced in glaucoma treatment. PA5108 demonstrated reliable, consistent, and sustained drug delivery, alleviating the common issue of poor medication adherence seen with traditional eye drop treatments. By providing prolonged drug release, the implant reduces the need for frequent administration, thereby improving patient compliance.
This is particularly important in South Africa, where healthcare access can be limited, and patients may struggle with adherence to daily treatment regimens due to logistical barriers or the need for frequent follow-up visits. Additionally, PA5108 addresses adverse effects associated with traditional treatments, such as prostaglandin-induced orbitopathy and ocular surface diseases, which can contribute to therapy discontinuation.
However, several challenges remain. The implant is still in the early stages of clinical development, meaning that approval, manufacturing, and distribution processes will take time. Moreover, the cost of the implant could be a significant barrier, particularly for patients relying on subsidized healthcare, where affordability is a key issue. The logistics of implant administration and the need for long-term monitoring will also require healthcare providers to be trained and resourced adequately.
Despite these challenges, implants such as PA5108 could offer a critical solution to South Africa’s glaucoma burden if made affordable and accessible. Addressing adherence issues and reducing side effects has the potential to prevent blindness and improve the quality of life for millions affected by glaucoma.
Conclusion
While the PA5108 implant is still far from being a widespread treatment option, its promising results suggest it could become an invaluable tool in managing glaucoma, particularly in resource-limited settings like South Africa. If the challenges of cost, accessibility, and healthcare infrastructure can be overcome, PA5108 and implants like it could significantly reduce the burden of glaucoma, helping to prevent blindness and improve outcomes for South African patients.
Importance of this study for South Africa
Glaucoma is the leading cause of irreversible blindness worldwide, with the highest prevalence of open-angle glaucoma among individuals of African descent. Globally, an estimated 60 million people are affected by glaucomatous optic neuropathy, and 8.4 million people are blind due to glaucoma. These numbers are expected to rise significantly, with projections of 80 million affected and 11.2 million blind by 2020. In Africa, glaucoma accounts for 15% of blindness, with the continent experiencing the highest incidence and prevalence of blindness compared to other regions.3
The situation is compounded by poor awareness, limited access to care, suboptimal diagnosis, and socio-economic deprivation, which often lead to late-stage disease presentation. As a result, glaucoma has earned its reputation as the "silent thief of sight" in Africa.
In South Africa, vision loss is a leading contributor to disability, accounting for 32% of all disabilities. With no cure for glaucoma, current treatments mainly rely on eye drops. However, adherence to this regimen is notoriously poor, exacerbating the disease’s burden. Non-compliance leads to inadequate disease management and increases the risk of blindness.3
A solution that improves sustained drug delivery, such as the PA5108 implant, could have a transformative impact on glaucoma treatment. By addressing the issue of poor patient adherence to eye drop therapy, this approach could not only improve treatment outcomes but also reduce the overall burden of glaucoma in South Africa. Ultimately, it could help prevent blindness and improve the quality of life for many individuals at risk.
2. Ophthalmology Times. (n.d.). Long-term blood pressure variability and visual field progression in glaucoma. Retrieved 11 December 2024 from https://www.ophthalmologytimes.com/view/long-term-blood-pressure-variability-and-visual-field-progression-in-glaucoma
Additional References
3. Baboolal, S., Smit, D. South African Eye Study (SAES): ethnic differences in central corneal thickness and intraocular pressure. Eye 32, 749–756 (2018). https://doi.org/10.1038/eye.2017.291
4. Brandon Biocatalyst. (2024, November 31). PolyActiva showcases promising clinical data highlighting its polymer technology’s potential to transform glaucoma care. Retrieved 11 December 2024, from https://brandonbiocatalyst.com/2024/11/01/polyactiva-showcases-promising-clinical-data-highlighting-its-polymer-technologys-potential-to-transform-glaucoma-care/
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