Clinical Trials
ISSUE NO. 43 — Advancing Vision Care With Formulation and Manufacture of Ocular Therapeutics
According to the WHO, at least a billion people are currently living with vision impairment from a preventable or treatable source. Precedence Research reports
that the global ophthalmic drug market size is estimated to double in 10 years, from $34.6 billion in 2021 to an estimated $68.93 billion by 2030.
The development of pharmacological interventions for many of these conditions has been accelerating, supported by new delivery methods and formulation approaches. For conditions that require surgery or corrective devices, eye drops are an important part of diagnosis, and pre- and post-surgery treatment plans.
In Issue 43 of The Altascientist, we explore key considerations for ophthalmic product manufacturing, including formulation, scalability, regulatory compliance, and quality control:
- Recent developments in ophthalmic medications
- Unique barriers for drug delivery to the eye
- Common types of ocular formulations
- Formulation for effective ocular drug delivery
- Systemic exposure of topical ophthalmic preparations
- Ocular gene therapy
- Manufacturing ocular drugs for clinical trials and commercialization
- A case study
THE CHALLENGES OF OCULAR DRUG DELIVERY
The eye has natural anatomical barriers that restrict the amount of medication reaching its intended target. These include the cornea’s outer layer, the conjunctiva, and the blood-aqueous and blood-retinal barriers. These structures resist water-based drugs, limit absorption, and tightly regulate what enters the inner eye. Additionally, the eye's rapid tear film turnover continuously flushes out medication. These barriers pose challenges for effective treatment—challenges that formulation specialists are striving to address with different formulation options.
SYSTEMIC EXPOSURE OF TOPICAL OPHTHALMIC PREPARATIONS
Ophthalmic topical medications are highly concentrated and can be absorbed systemically due to the passage of medication through the nasolacrimal duct into the highly vascular nasal mucosa. Systemic exposure to eye drops occurs when the active ingredients in the drops are absorbed into the bloodstream.
This can happen through the tear duct, the conjunctiva, or the skin around the eyes. Systemic exposure can produce side effects, which formulation scientists work to minimize. Systemic exposure to ophthalmic medications is influenced by several factors, including the high concentration of active ingredients in eye drops, administration techniques that impact absorption, and patient populations, such as infants, pregnant or nursing women, and the elderly are more susceptible to systemic side effects.
HOW CAN ALTASCIENCES HELP
With a deep understanding of regulatory requirements for ophthalmic formulations and cutting-edge manufacturing techniques, Altasciences provides comprehensive services tailored to meet the highest industry standards for your ophthalmic drug development program. We offer customized solutions that align with your specific needs, delivering an optimized suite of services to deliver high-quality ophthalmic drugs for clinical trials or commercial use.
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Altasciences Supports Metsera in Their Early-Stage Clinical Trials for Obesity
Laval, Québec, November 21, 2024—Altasciences is proud to have supported Metsera, Inc., a clinical stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, on its nonclinical and early-stage clinical trials. This support includes a recent Phase I/II trial of MET-097i, an ultra-long-acting injectable, fully biased GLP-1 receptor agonist.
In September, Metsera reported positive topline results from the clinical trial conducted at Altasciences’ facility, in which MET-097i demonstrated a 7.5% reduction in body weight from baseline at day 36 (one week after the final dose) and a 380-hour half-life. This work enabled Metsera to recently initiate a randomized 16-week Phase II trial of MET-097i.
In addition to clinical conduct, Altasciences supported Metsera with its proactive drug development solution, including nonclinical, bioanalysis, CRO and program management services for several additional therapeutic candidates. Over the past six months, Altasciences has completed nonclinical work for MET-233i, an ultra-long-acting injectable amylin analog, as well as MET-002, an oral GLP-1 receptor agonist peptide, which has proven instrumental in allowing Metsera to begin clinical trials for both programs this year.
"Congratulations to Metsera on reaching this significant milestone in the development of MET-097i," said Ingrid Holmes, Vice President of Global Clinical Operations at Altasciences. "Metsera is a highly valued partner of Altasciences, and we are proud to have contributed to this program aimed at helping individuals struggling with obesity-related illnesses."
Obesity impacts millions of people worldwide and is a driver of serious health risks, including type 2 diabetes, heart disease, and certain cancers. Innovative treatments, like MET-097i, could offer potential new treatment options for those affected by this complex condition.
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 30 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. To learn more about Altasciences, visit altasciences.com.
Julie-Ann Cabana
Altasciences
jcabana@altasciences.com
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