Archive for the 'Intraocular Pressure' Category

FDA approves Hi-Tech Pharmacal’s generic ophthalmic solution

The U.S. Food and Drug Administration has given the final approval to Hi-Tech Pharmacal Company’s dorzolamide and timolol ophthalmic solution, the generic for Merck’s Cosopt®. Indicated for lessening elevated intraocular pressure in patients suffering from ocular hypertension or open-angle glaucoma, the generic solution will be launched in the markets soon. Hi-Tech Pharmacal Co. Inc. specializes in manufacturing semi-solid and liquid dosage forms of sterile ophthalmic and inhalation products.

CHMP recommends Azarga for approval

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on recommendation for approval to grant a marketing authorisation for Alcon Laboratories’ Azarga 10 mg/ml / 5 mg/ml Eye drops. The suspension will be a more effective treatment of elevated intraocular pressure for adult patients suffering from ocular hypertension or open-angle glaucoma who have not benefited much from mono-therapy.The drug is a fixed combination of Timolol and Brinzolamide. These compounds reduce the production of aqueous humor by inhibiting the conversion of CO2 to bicarbonate in the eye’s ciliary body, hence controlling IOP.

Allergan-Asterand agreement for compounds

Irvine of Allergan, Inc. will be giving $6.25 million to Asterand, an eye research company under an exclusive license agreement for selective compounds. These compounds arise from Asterand’s R99 development programme and are effective in reducing intra-ocular pressure. Allergan is planning to launch these compounds in market, once through with clinical development. Along with this amount, Asterand will be receiving other benefits such as payments for sales milestone, leading to a total of $56 million, excluding royalties.