PDP - 716
Brimonidine is the one of the most commonly used treatment of glaucoma and ocular hypertension.
Brimonidine is dosed TID in the US and BID or TID in other countries. Due to the dose intensive schedule, patient adherence to Brimonidine therapy is low. Studies on individual adherence with Brimonidine ophthalmic solution for the treatment of glaucoma have shown that adherence of patients was highly variable and pharmacologically insufficient for more than two thirds of the patients when they were asked to administer Brimonidine eye drops multiple times in a day1, 2. These findings demonstrate the necessity to develop new strategies to improve compliance in glaucoma therapy with Brimonidine.
SPARC is developing novel once-a-day Brimonidine Eye Drops using proprietary TearActTM Technology which would provide controlled and continuous delivery of drug thereby increasing bioavailability and duration of action hence improve individual adherence and compliance.
Following successful completion of Phase 2 proof-of-concept study, SPARC submitted IND in Q4 FY18. Phase 3 study has been initiated in Q1 FY19 with the aim of submitting NDA by Q4 FY20.