Brinzolamide

ALLEGAN, Mich., Oct. 13, 2023 /PRNewswire/ -- Padagis today announced the launch of Brinzolamide Ophthalmic Suspension with Competitive Generic Therapy (CGT) exclusivity (generic equivalent to the Reference Listed Drug Azopt® Ophthalmic Suspension). Azopt® Ophthalmic Suspension is indicated to decrease elevated intraocular pressure (IOP) in adult patients with ocular hypertension or open-angle glaucoma, as monotherapy in patients unresponsive to betablockers or in patients in whom beta-blockers are contraindicated, or as adjunctive therapy to betablockers. Annual market sales for Azopt® were approximately $74 million in the 12 months ended August 2023 as measured by IQVIA. Padagis President, Pamela Hoffman, stated, "This launch and its accompanying CGT exclusivity demonstrates the ability of the Padagis team to bring complex generic products to the markets that need them. The Padagis team continues to leverage our unique and specialized technical and commercial capabilities to deliver important products to our customers and patients." About Padagis Padagis is dedicated to improving the well-being of patients and consumers by providing high quality, affordable, specialized healthcare products. The company is a leading provider of extended topical and other specialty pharmaceuticals to its primary markets of the United States and Israel. Padagis employs over 1,300 people worldwide. Visit Padagis online at (). SOURCE Padagis

Alcon announced Tuesday it is buying out Aerie Pharmaceuticals for about $770 million to gain access to the latter's open-angle glaucoma and ocular hypertension treatments. As part of the deal, Alcon will acquire Aerie’s approved drugs Rocklatan (netarsudil and latanoprost ophthalmic solution) and Rhopressa (netarsudil ophthalmic solution). Both are eye drops that help reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Rhopressa launched in the United States in 2018 and works by suppressing the enzyme rho kinase, which is known to induce a build-up of fluid in the eyes. One year later, Aerie combined Rhopressa with latanoprost to produce Rocklatan, which achieves a stronger effect by enabling more drainage routes for eye fluid. The deal includes a per-share price of $15.25, representing a 37% premium to Aerie’s last closing price. The overall acquisition value was calculated using Aerie’s outstanding shares of 49.36 million, as of Monday. Alcon will also add Aerie’s Phase III candidate AR-15512 to its roster of drugs in development. Designed against the cold-sensitive receptor transient receptor potential melastatin 8, AR-15512 is an investigational eye drop for dry eye disease. “Aerie is a natural fit with on-market and pipeline products, and R&D capabilities that offer the infrastructure needed to expand our ophthalmic pharmaceutical presence,” David Endicott, CEO of Alcon, said in a statement. News of the buyout fanned industry interest in Aerie, as the company's shares jumped 32% to $14.72 a piece in premarket trading Tuesday. Aside from Aerie’s commercial and mature compounds, Tuesday’s acquisition also transfers several promising early-stage candidates to Alcon. These include three retinal implants - AR-1105, AR-13503 SR and AR-14034 SR - for age-related macular degeneration and diabetic macular edema, both major drivers of blindness among adults worldwide. Aerie’s implants aim to strike an optimal balance between infrequent eye injections and tight monitoring of treatment efficacy and safety. Alcon Continues Foray into Eye Drop Space The Aerie deal is the latest move in Alcon's quest to establish a bigger foothold in the therapeutic eye drop space. In April 2021, the company announced it had acquired exclusive commercialization rights to Novartis’ Simbrinza (brinzolamide and brimonidine) in the U.S. Approved in 2013, Simbrinza combines the action of its carbonic anhydrase inhibitor and alpha-2 adrenergic receptor agonist components to lower intraocular pressure. Simbrinza continues to be under patent protection until 2030, effectively giving Alcon nearly a decade of exclusivity to this mechanism of action before it starts to lose sales to generic competitors. In May, Alcon also bought out the commercial portfolio and associated intellectual property assets of Massachusetts-based Kala Pharmaceuticals. The deal included two heavy-hitters in the dry eye space: Eysuvis (loteprednol etabonate ophthalmic suspension) and Inveltys (loteprednol etabonate ophthalmic suspension). Both drugs have a strong market presence. Kala filled nearly 27,000 prescriptions for Eysuvis, the only FDA-approved drug for the short-term relief of dry eye symptoms, in the first quarter of 2022 alone. This was an 18% quarter-on-quarter growth. And while Inveltys sales dropped slightly during the same period, it still managed to fulfill nearly 35,000 prescriptions.