PolyActiva,
an Australian biopharma company, has developed a biodegradable latanoprost
implant. The PA5108 Ocular Implant employs the proprietary Prezia™ Sustained
Drug Delivery Technology to release a constant daily dose of latanoprost.
The
rod-shaped implant is injected in the anterior chamber, where it sinks into the
lower part of the angle, being heavier than aqueous.
The
implant is made of biodegradable polymer and is mildly adhesive to the iris.
The
implant leaches latanoprost with zero-order kinetics and degrades completely
leaving no residue post-dissolution and minimizing adverse effects.
Phase
II trial has shown:
- Statistically significant intraocular pressure (IOP) changes from baseline were observed for each mean diurnal measurement at Weeks 12, 21, 33, and 42 (p<0.0001).
- Clinically meaningful IOP reductions at 8 am over 48 weeks were observed, with mean IOP reductions between 26 and 35%.
- 94% of participants did not require additional drop therapy over the 48-week treatment period.
- Full implant biodegradation by week 40.
PolyActiva’s
Phase 2 clinical trial involved 15 participants. There was more than 20%
reduction in the IOP.
Studies
have found the implant safe for the cornea, iris, and other intra-ocular
structures. There was no inflammatory reaction to the implant.
The
company also claims that latanoprost does not seep into the orbit, unlike
topical drops which can cause prostaglandin analogue-induced orbitopathy. There
is no ocular surface disease, dry eyes, or irritation with the implant, some common
side-effects seen with drops.
The
PA5346 Latanoprost FA SR Ocular Implant is a second-generation single-dose (100
ng/day) device that could function for 12 months.
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