Latanoprost + Timolol once a day ophthalmic

Latanoprost and Timolol are existing drugs used for the treatment of glaucoma. Typically, these drugs need to be instilled life long.

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. Glaucoma is said to be the second leading cause of blindness globally.

Both these drugs- Latanoprost and Timolol, have different mechanisms of action. In over 40% of patients with glaucoma, a combination of drugs is required to be given. However, if these drugs are given singly and one after the other, there is a strong likelihood of the drug that is administered the first being washed out.

The currently marketed Latanoprost and Timolol combination contains a preservative, Benzalkonium Chloride (BAK). BAK not only acts as a preservative, but it also solubilizes the drug in its micellar structure. It also increases resorption of latanoprost active form. However, it has been shown that on long term use, such BKC containing eye drops may be harmful to the eye surface.

Our product contains BAK-free Latanosprost for improved ocular retention. Removal of BKC reduces tearing, burning, itching, and hence reduces drainage from the surface of the eye. Another advantage is that our product contains latanoprost in an unbound form, which also enables its partition across eye tissues.

The second active ingredient in our formulation is Timolol. Timolol is typically instilled into the eye 2-3 times a day. SPARC's unique Timolol OD formulation traps the drug in a viscous matrix. However this unique polymer mix has been created with the similar properties as natural tears, so there is no change in visibility. Timolol is released gradually from this matrix during the course of the day. This Timolol OD has clinically been proven to be equal to twice-a-day Timolol.

Our combination product contains essential features of our two ophthalmic platform technologies.

SPARC is pursuing the 505(b)(2) route for development of this delivery system.

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