GFR Timolol Maleate once-a-day ophthalmic developed by the team at SPARC has been launched in India to very good acceptance.
Chronic eye ailments like glaucoma typically require short-duration drugs to be instilled several times a day. To increase the duration of action of such drugs, and to localize drug action with minimal systemic absorption, also to create a clear and non irritant formulation, SPARC has developed a Gel Free Reservoir (GFR) technology.
GFR technology uses a unique polymer ratio that does not decrease visual clarity and has desired flow property. The physical properties of our product are similar to natural tears. The product has the characteristics of an ideal eye drop- clear colorless solution, bioadhesive yet non sticky.
Equivalent efficacy of Timolol maleate 0.5% administered once a day was established in clinical trial in 100 patients comparing with Timolol Maleate 0.5% administered twice a day.
Latanoprost SMM and Timolol GFR combination: This product has been launched in India.
SPARC is also working in a fixed dose combination of Latanoprost and Timolol.
After completing Phase-III trial in India, with successful achievement of a non-inferiority margin, this product was launched in India.
The product will be filed in select emerging markets this year. We have also obtained guidance from the European regulatory consultants for European filing, and also the commercial potential of this formulation is being evaluated.