Christopher Cole

·Grifols received FDA clearance to initiate a Phase II trial of GRF312, an immunoglobulin (IG)-based eye drop for treating dry eye disease.

·The trial builds on Phase I/II data showing significant symptom reduction with IG drops and no difference in safety profile compared with placebo.

·This marks a potential first use of IG for an ocular surface indication, expanding its therapeutic scope beyond systemic applications.

FDA on paper texture | Image Credit: © Araki Illustrations.

, a global healthcare company specializing in plasma-derived medicines, announced on May 21, 2025 (1) that it has received clearance from 

 to initiate a Phase II clinical trial of its immunoglobulin-based eye drop, GRF312 Ophthalmic Solution, for the treatment of dry eye disease (DED).

Dry eye disease is a chronic, multifactorial inflammatory condition that affects more than 100 million individuals worldwide, according to a company press release (1). It is characterized by insufficient tear production or excessive tear evaporation, leading to ocular discomfort, pain, and in severe cases, irreversible damage to the ocular surface. Standard treatments—such as artificial tears, corticosteroids, cyclosporine, and lifitegrast—may take weeks or months to deliver meaningful relief and do not work for all patients.

The Phase II trial is expected to begin in the third quarter of 2025 and will evaluate the safety, tolerability, and efficacy of GRF312 in 100 patients with DED. The clinical program builds upon a Phase I/II pilot study led by Grifols’ partner 

University of Illinois College of Medicine, Department of Ophthalmology

, according to Grifols (1). That study demonstrated a significant reduction in both signs and symptoms of DED after eight weeks of treatment with the IG formulation, administered twice daily. The tolerability profile was comparable to that of placebo.

“We believe our immunoglobulin eye drops have the potential to make a qualitative leap in how dry eye disease is treated,” said Dr. 

Jörg Schüttrumpf, Grifols chief scientific innovation officer

 in the May 21 release (1). “Research suggests that the broad-spectrum anti-inflammatory and immunomodulatory properties of an ocular surface IG are superior to currently approved therapies, including artificial tears and anti-inflammatories. We are using our extensive and deep knowledge of immunoglobulins to benefit the millions of patients globally who aren’t receiving sufficient relief.”

Development of GRF312 stems from a 2023 collaboration and licensing agreement between Grifols and Selagine, under which Grifols acquired exclusive global rights to the IG-based ophthalmic treatment (2). The agreement leverages Grifols’ capabilities in developing and manufacturing immunoglobulin therapies and Selagine’s research and clinical experience in ophthalmology.

“Selagine and Grifols joining efforts and complementary expertise successfully led the treatment to a Phase II clinical trial,” said 

, founder and President of Selagine and BA field professor of ophthalmology at the 

University of Illinois College of Medicine

. “The results obtained to date and this promising development reinforce the potential of this novel treatment approach to significantly improve the quality of life of dry eye disease patients.”

The trial marks one of the first formal efforts to investigate immunoglobulin as a therapeutic agent for the ocular surface—a potential first-in-class application. If successful, GRF312 could represent a new mechanism of action for addressing inflammation and immune dysregulation in DED, with implications for both patient outcomes and therapeutic innovation.

 that its subsidiary Biotest had garnered its first FDA approval with the intravenous immunoglobulin therapeutic, Yimmugo (3). Set to be distributed by Kedrion, preparations for an early 2025 launch in the United States was underway as of October 

2024 for Yimmugo (4). No further news of the launch was available at the time of writing.

Grifols Receives FDA Clearance of IND Application for Phase 2 Trial of Immunoglobulin Drops for Dry Eye Disease

Grifols Enters into Global Collaboration and Licensing Agreement with Selagine to Develop Immunoglobulin Eye Drops to Treat Dry Eye Disease. Press Release

FDA Approves Immunoglobulin Therapeutic to Treat Primary Immunodeficiencies

Expanding Treatment Options: Yimmugo® Coming Soon for PID Patients in the US

Articles

Grifols received FDA clearance to begin a Phase II trial of GRF312, an immunoglobulin eye drop for dry eye disease, aiming to improve current treatments.

IND Application Cleared for Phase II Trial of Grifols’ Dry Eye Disease Drops

· ACG’s PCM enables on-demand production of personalized capsules using real-time health data, precise dosing, and automated manufacturing.

· The ACG–AoY partnership combines advanced capsule tech and formulation expertise to create science-backed, customized supplements.

· With 1,500+ machines planned in Europe and €500M revenue forecasted, PCM shows strong commercial potential for scalable personalized nutrition.

A group of antibiotic pill capsules falling. Healthcare and medical 3D illustration background | Image Credit: © James Thew - stock.adobe.com

Thanks to an exclusive partnership with Art of You (AoY)—a personalized supplement development company—the ACG Group (ACG) announced its world-first Personalised Capsule Machine (PCM) for creating custom-formulated supplement capsules that can be individualized on demand to the specific needs of a given patient (1). As a fully integrated manufacturing solutions provider for the global pharmaceutical and nutraceutical industries, ACG developed PCM to create individualized supplements by merging precise dosing, real-time health data, and automated capsule production.

The AoY–ACG partnership integrates AoY’s formulation knowledge and experience along with ACG’s beadlet and capsule technologies to create a one-of-a-kind system for delivering bespoke supplement solutions that match individuals’ biomarkers, lifestyle choices, and health goals.

“A True Leap Forward in Personalized Nutrition”

“After five years in development, we are thrilled to launch the PCM and collaborate with Art of You on this groundbreaking initiative. It represents a true leap forward in personalised [sic] nutrition,” said Aaron Quinn, senior manager for Europe at Vantage Nutrition, part of the ACG Group. “This partnership underscores our commitment to growth through innovation and focus on advancing health solutions globally. With over 1,500 PCM machines planned for deployment across Europe in the next five years and projected revenue of more than €500 million over the next three, this initiative highlights ACG’s leadership in delivering cutting-edge capsule and beadlet technologies to the market.”

Adding to Quinn’s sentiments, AoY Co-Founder Pablo Smolders said “We are proud to showcase this exciting new collaboration at Vitafoods Europe. By leveraging ACG’s exceptional capsule technologies alongside our own expertise, we are bringing our vision of science-backed, personalised wellness closer to reality.”

The news comes as AoY team members are joining ACG at Vitafoods Europe, held May 20-22 in Barcelona (2), where they’re discussing the science, vision, and technology that helped that innovation come to life.Also at the show, ACG’s Vantage Nutrition division is presenting “advanced ingredient delivery technologies including controlled release beadlets, liquid-filled hard capsules, and cap-in-cap dosing solutions,” according to a press release shared by ACG (1).

PCM, according to ACG, is able to deliver:

Scientifically validated, research-based compositions

Enhanced absorption and nutrient delivery

Plant-based, flavor-neutral, and free from microplastics

Eco-conscious production meeting pharmaceutical standards

showcased it’s line of sustainable packaging solutions

 at Pharmapack Europe. In particular, ACG highlighted its CelluPod paper-based, recyclable, and compostable blister system for products that require low water vapor transmission rates (WVTR). The company also featured its packaging solutions that are free of polyvinyl chloride (PVC). These include its PVC and Halogen-Free Thermoforming Blister System for products requiring low to medium WVTR. ACG also provides an eco-friendly alternative in its Bio D PVC. The company’s Halogen-Free Cold Form Blister System also provides a high-performance sustainable solution without halogen and PVC.

 sat down Anil Andrade, vice-president of Global Sales at ACG World, during CPHI Milan to discuss growth in demand in the pharma industry and efforts put forth to achieve sustainable operations. In the interview, Andrade talked about the changing perceptions of the industry and the importance of sustainability in pharmaceutical operations. During the past 10 to 15 years, ACG has seen global growth in demand, and more so in Europe, North America, and Asia. Andrade also emphasized efforts to achieve sustainability to reduce the impact on the environment (3).

“Manufacturing capsules consumes a lot of water, and we have been trying to make our operations more efficient so that they consume less water, less paper, less plastic,” Andrade explained. “In Croatia, as an example, we have reduced the paper consumption by almost 25 tons in a year. Same with plastic, we have reduced the consumption of plastic by 25 tons, and that has related to the benefits that we see going forward.”

ACG unveils patented personalised capsule technology

CPHI Milan 2024: Growth and Sustainability in the Pharma Industry

ACG partnered with Art of You to launch the world-first Personalised Capsule Machine, enabling on-demand, customized supplement capsules based on individual health data.