Sun Pharma gets CDSCO panel nod to Brinzolamide, Timolol Maleate, Potassium Sorbate FDC

This came after drug-maker Sun Pharma presented their proposal for manufacturing and marketing Brinzolamide IP 10mg plus Timolol Maleate IP 5mg plus Potassium Sorbate IP 0.47%w/v ophthalmic suspension along with a request for a waiver to conduct a Phase III clinical trial.

Brinzolamide is a sulfonamide and carbonic anhydrase inhibitor with a specific affinity for carbonic anhydrase II. Following topical ocular administration, brinzolamide inhibits carbonic anhydrase II, an enzyme that is responsible for the movement of sodium and fluid transport in the eye. This inhibition leads to a decrease in aqueous humor secretion, probably by slowing the formation of bicarbonate ions, and results in a reduction in intraocular pressure. Brinzolamide is used to treat increased pressure in the eye caused by open-angle glaucoma.

Timolol is a non-selective beta adrenergic blocker used in the treatment of elevated intraocular pressure in ocular hypertension or open angle glaucoma.

Potassium sorbate is a potassium salt having sorbate as the counterion. It has a role as an antimicrobial food preservative.

At an earlier SEC meeting dated August 27, 2021, the committee noted that no ophthalmic formulation is approved with potassium sorbate in the country and potassium sorbate may alter the ocular bioavailability of Timolol.

Accordingly, the Committee at its earlier meeting recommended that the firm conduct a Phase III clinical trial with the proposed formulation and submit the trial protocol for further review by the Committee.

Moving further, the committee at a recent SEC meeting reviewed Sun Pharma's proposal for manufacturing and marketing Brinzolamide IP 10mg plus Timolol Maleate IP 5mg plus Potassium Sorbate IP 0.47% w/v ophthalmic suspension.

The committee noted that the FDC is already approved and the firm is changing the preservative from BKC to potassium sorbate. The committee also noted that the frequency of administration as well as dose remain the same as that of the already approved FDC.

After detailed deliberation, the committee recommended the grant of permission for manufacturing and marketing of the proposed FDC with the condition that the firm conduct a Phase IV clinical trial.

Further, the committee directed that a phase IV clinical trial protocol should be submitted within 3 months of the product's approval.