Drug Companies Petition Supreme Court to Hear Case Challenging Eye Drop Size

April 6, 2018: By Jon Swedien

Alcon, Allergan, and Bausch + Lomb are among the companies that have petitioned the US Supreme Court to hear a case challenging the size of eye drops.

The petition comes in the wake of conflicting federal appeals court decisions in similar cases brought by patients who use glaucoma medications. Plaintiffs in both cases argued that the drugmakers should sell bottles that dispense smaller drops, which would waste less product and save consumers money.

One of the appeals court decisions (Cottrell v. Alcon) sided with plaintiff. In the other case (Eike v. Allergan)—with similar allegations—the court found in favor of the companies. The companies petitioned the high court to hear Cottrell v. Alcon.

In Cottrell v. Alcon, the plaintiffs pointed to studies sponsored and published by the defendants that found eye drops should be 5 to 15 μLs in order to maximize the amount of the medication entering the inner eye. The plaintiffs went on to note that the size of the defendants’ eye drops was more than two- to three times the maximum recommended size in the studies, and as such, led to wasted product.

In their petition, the companies defended their products’ packaging, noting it is FDA approved. They also argued that smaller drops, for numerous reasons, would not necessarily result in lower prices—and that the cost of changing the drop size could actually be passed onto consumers.

“Whether petitioners would be able to offer smaller drops (and, if so, at what price) is itself significantly affected by FDA and its approval process and post-approval requirements,” the petition said.

The Supreme Court hears just a small fraction of the cases it is asked to take up each year, but it does tend to favor cases where circuit courts have made conflicting rulings.

Need Deeper Analysis? Sign up for Market Scope's monthly newsletter to get in-depth coverage of the ophthalmic market, including quarterly procedure volumes based on survey data and meeting coverage from around the world.

Recent Ophthalmic News

US Health Secretary Alex Azar Takes Aim at Rebates in US Senate Hearing

Beyeonics Surgical Raises $11.5 Million in Initial Funding Round

MeiraGTx Raises $75 Million in Initial Public Offering

GenSight to Pursue Approval for LHON Gene Therapy Candidate, Despite Phase III Setback

Optovue Receives FDA Clearance for AngioAnalytics, First OCT Angiography Metrics

Nexy Robotic Retinal Imaging System Receives FDA Clearance

Ocutrx Receives US Patent for Oculenz AR Glasses for Macular Degeneration

Allergan’s Bimatoprost SR Demonstrates Noninferiority to Timolol in Phase III Glaucoma Study

KKR to acquire Envision Healthcare, Including Amsurg ASC Business

Ophthalmologist Carmen Puliafito, MD, Seeks to Regain Medical License

Avedro Gains J Code for Photrexa Formulations in Preliminary CMS Decision

EyeGate Seeks to Study Ocular Bandage Gel in Punctate Epitheliopathy

Nicox, Ironwood to Collaborate on Novel Ophthalmic Treatments

US FDA Approves MDGH’s Moxidectin for Treatment of River Blindness

Bausch + Lomb Enrolls First Patient in Trial for enVista MX60EF Trifocal IOL

Cincinnati Eye Institute Partners with Private Equity Firm to Pursue National Expansion

Ophthotech Enters Gene Therapy Deals with University of Florida, University of Pennsylvania

Teva’s Launches Generic Version of Restasis in Canada

Clearside’s Phase II Trial for DME Candidate Meets Primary Endpoint

Orasis Raises $13 Million in Series B Financing

Coming soon

2018 Glaucoma Device Report: A Global Market Analysis for 2017 to 2023