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A brand of latanoprost, Latoprost RT has been launched in the Indian market with excellent response.
Glaucoma is a type of optic neuropathy characterized by progressive injury to the retinal ganglion cells. Elevated intraocular pressure (IOP) is considered the primary cause of the optic nerve damage.
Prostaglandin analogues such as Latanoprost are the first line treatment for glaucoma and form the largest drug class.
The currently marketed Latanoprost contains a preservative, Benzalkonium Chloride (BAK). BAK not only acts as a preservative, but it also solubilizes the drug in its micellar structure and is used in almost double quantity than normally required.
However, it has been shown that on long term use, such BAK-containing eye drops may be harmful to the eye surface. EU requires replacing of BAK from eye drops wherever possible. Also, such BAK containing latanoprost drops are not stable at room temperatures, and may require storage at 2-8 degrees C.
SMM technology is a platform technology that has been developed by SPARC for solubilizing ophthalmic drugs with limited or no solubility. This technology does not require the use of quaternary ammonium preservative/surfactant like Benzalkonium Chloride which may be damaging to the eye.
Our product contains BAK-free Latanoprost. It is a patented formulation of Latanoprost with similar strength and dosing. Removal of BAK reduces tearing, burning, itching, and hence reduces drainage from the surface of the eye. Our product does not need any special refrigeration for storage/ transport.
SPARC completed a 4 week, randomized, multicenter Phase III study with 100 subjects to compare the safety and efficacy of SPARC’s latanoprost with Xalatan. Clinically and statistically significant reductions in IOP were observed with SPARC’s latanoprost. Safety and efficacy outcomes were comparable to Xalatan. A 8-week study on 25 subjects demonstrated improved tear-break-up-time and overall ocular surface disease index scores after switching patients from a BAK-containing latanoprost to the BAK-free latanoprost.
IND has been approved at the USFDA. The USFDA had required a Phase III study for product registration, and enrollment is well underway.
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