Timolol

Akums Drugs & Pharmaceuticals Ltd. has announced the launch of a pioneering Ripasudil-Timolol combination therapy for glaucoma treatment. This Drugs Controller General of India (DCGI)-approved product represents a significant advancement in ophthalmic care, with Akums becoming the first Indian CDMO to receive approval for this innovative formulation. Glaucoma ranks as the second leading cause of irreversible but preventable blindness worldwide, with India contributing to 23.5 percent of the global burden. The condition remains third among causes of vision impairment in India, after cataract and refractive errors. Also, Ocular hypertension is closely linked to glaucoma, many eye care professionals consider ocular hypertension to be a precursor or warning sign for glaucoma. Ocular hypertension refers to elevated pressure within the eye (intraocular pressure or IOP) that is higher than normal but without detectable damage to the optic nerve or visual field loss that would indicate glaucoma. While not everyone with ocular hypertension develops glaucoma, regular monitoring is crucial. Managing both conditions primarily involves lowering intraocular pressure to prevent further complications. The new combination therapy offers a dual mechanism of action for superior intraocular pressure (IOP) control: Ripasudil enhances aqueous humor outflow through the trabecular meshwork, while Timolol reduces aqueous humor production. This synergistic approach delivers more substantial and sustained IOP reduction compared to single-drug treatments. Sanjeev Jain, Managing Director of Akums Drugs & Pharmaceuticals Ltd., said, "This innovation integrates two distinct mechanisms of action to improve glaucoma treatment. By enhancing efficacy and ease of use, we aim to offer a more practical and patient-friendly solution. Our focus is on better clinical outcomes, reducing disease progression, and ultimately improving the quality of life for those affected. With a patient-first approach and a commitment to Make in India, we continue to develop solutions that are of high-quality, and aligned with global standards." The single combination drop formulation significantly simplifies treatment regimens, addressing a major challenge in glaucoma management—patient adherence. By combining two medications into one product, patients benefit from enhanced convenience and potentially improved compliance. "With the rising prevalence of glaucoma in India, introducing therapies that enhance efficacy and patient compliance is crucial," added Sandeep Jain, Managing Director of Akums Drugs & Pharmaceuticals Ltd. "This launch marks a significant step in making high-quality and effective treatment more accessible," added Jain. Akums will utilise its manufacturing facilities to ensure consistent supply and the broad availability of this breakthrough therapy. With approximately 11.9 million people affected by glaucoma in India, this innovative combination addresses a critical healthcare need by providing an effective solution that simplifies treatment while potentially improving outcomes.

Formosa Pharmaceuticals has signed an exclusive licensing agreement with DÁVI Farmacêutica (DÁVI) in Portugal, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05 percent (APP13007), a marketed innovative medicine for the treatment of inflammation and pain following ocular surgery. DÁVI is a trusted partner of Pharmathen Global Holding B.v., AZAD Pharma AG, NTC S.r.l. and Pfizer through the marketing and promotion of Xalacom (Latanoprost + Timolol) and Xalatan (Latanoprost) for more than 12 years. DÁVI is one of the key players in the Portuguese Market, with over 100 years' history in the distribution and promotion of branded ophthalmology products. Clobetasol propionate ophthalmic suspension, 0.05 percent (APP13007), approved by the US Food and Drug Administration (FDA) in March 2024, was recently launched in the United States in September 2024. The DÁVI licensing agreement includes upfront, commercialization milestones, and sales milestones, with additional considerations throughout the term of the agreement. APP13007's active ingredient is the superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma's proprietary APNT nanoparticle formulation platform. The novel formulation enables a convenient and straightforward dosing regimen (twice daily for 14 days) while providing rapid and sustained relief of inflammation and pain. In a recent survey of 100 ophthalmic surgeons, rapid resolution of pain (~80 percent pain-free four days post-surgery) and low incidence of adverse events (<2 percent) were highlighted as key drivers to prescribing APP13007. APP13007 anticipates significant potential in Portugal, which has around 90,000 cataract surgeries, annually, as reported by Eurostat. "This partnership with DÁVI Farmacêutica, marks our first entry into a competitive EU market, opening the door for growth into other EU territories. DÁVI's experience and commitment to novel ophthalmic therapies is steadily apparent and Formosa Pharma appreciates their recognition of APP13007 as a worthy offering to patients recovering from ocular surgery," said Erick Co, President and CEO, Formosa Pharmaceuticals. Rui Alves, Business Development Manager of DÁVI Farmacêutica, stated, "We are excited at DÁVI to be partnering with Formosa and have the opportunity to offer this cutting-edge drug and technology to our ophthalmologists and patients, reinforcing our strong position in the market and the commitment to enhance the well-being of our people."