Dr Reddy's inks pact with Slayback Pharma of US to acquire rights for OTC ophthalmic product

HYDERABAD: Pharma major Dr Reddy’s Laboratories has entered into a licensing agreement with New Jersey-based Slayback Pharma LLC (Slayback) to acquire the rights of the latter's Brimonidine Tartrate Ophthalmic Solution 0.025%, which is the private label equivalent of Bausch + Lomb’s Lumify in the US market.
Lumify is an over-the-counter (OTC) eyedrop that can be used to relieve redness of the eye due to minor eye irritations.
Slayback Pharma is the first company to file an abbreviated new drug application (ANDA) with the US drug regulator US Food & Drug Administration (USFDA) for the private label equivalent of Lumify under Paragraph IV certification. The ANDA is currently under USFDA review and covers Brimonidine Tartrate Ophthalmic Solution 0.025% in 2.5 ml and 7.5 ml fill volumes, it said.
The agreement with Slayback also provides Dr Reddy’s exclusive rights to Brimonidine Tartrate ophthalmic solution outside the US market, Dr Reddy’s said on Saturday.
“We are pleased to license this important OTC ophthalmic product for the US market. It complements our growing OTC product portfolio in the eyecare category that includes the private label versions of Pataday once daily relief and Pataday twice daily relief,” said Marc Kikuchi, CEO-North America generics, Dr Reddy’s.
“Slayback is proud to develop this first-to-file ANDA for Lumify, a significant OTC product in the eye redness reliever category, that continues to highlight the R&D capability of the company,” said Ajay Singh, CEO & founder, Slayback.
As per estimates, the value of the total addressable market for Brimonidine Tartrate ophthalmic solution in the US is pegged at approximately $130 million for the 52 weeks ended June 12, 2022.