May 2012




Cataract editor's corner of the world

Drug development in the eyes of industry

by Faith A. Hayden EyeWorld Staff Writer

When a physician orders a medication for a patient, the main concerns are drug choice, dosage, side effects, and compliance. However, when the patient retrieves the medication, other issues such as availability, brand versus generic, and cost become apparent. Many of these factors involve the drug manufacturers' interactions with the FDA. To better understand the complicated pathway for a drug to become approved, we talked to some representatives from leading pharmaceutical companies.

Bonnie An Henderson, M.D., cataract editor


Source: Image Source/Getty Images

It's no secret that funneling medical devices and new drugs through the FDA channel can be a frustrating, cryptic process; doctors comment on this fact at meetings and on forums all the time. But opinions from drug companies themselves are a less-frequently heard perspective. How do companies feel about the drug pathway? What goes into, for example, the decision for post-approval studies? EyeWorld spoke to Scott Krueger, Ph.D., head of portfolio and project management, Alcon (Fort Worth, Texas), and Andrew Chang, director of product marketing, ISTA Pharmaceuticals (Irvine, Calif.), on their viewpoints.

EyeWorld: From start to finish, how long does it take to get a new drug approved in the U.S. and in Europe?

Alcon: From identification of the new eyecare drug to its approval, it takes 7-10 years on average in both the U.S. and the E.U.

EyeWorld: Can you take us through, step-by-step, a typical pathway from the origin of a new drug idea to having the drug approved?

Alcon: Our new product development process begins with identifying the existing unmet needs in the selected research area. This could be, for example, a product that requires a lower dosage frequency, reduces potential side effects, or provides increased efficiacy. Following the research phase, we identify the selected drug and conduct a proof-of-concept to ensure that the drug achieves the desired effect in the targeted patient population. If successful, this is followed by additional clinical trials with larger populations and, finally, the submission of the dossier to regulatory bodies for approval.

EyeWorld: What is the average total cost of getting a new drug approved? Do you expect this amount to peak at some point, or will the total cost continue to rise? If costs continue to rise, what does that mean for the pharmaceutical industry and drug innovation?

Alcon: Depending on the disease being targeted, new eyecare drug development costs between $70-150 million per product. We expect costs will continue to rise to meet the increasing thresholds of both regulatory and payer requirements, but we are also making serious efforts to limit the rate of increasing per-patient costs. Rising development costs could have a negative influence on innovation and result in further consolidation in the industry.

ISTA: The costs to approval continue to increase and with no guarantees. Phase III trials can be three times more than similar trials in years prior. There are also special protocol assessments that are needed within each step of Phase I, II, and III, and there are fees associated with almost every step of the process.

EyeWorld: Once a drug is approved, are there additional trials?

Alcon: Additional R&D trials are conducted primarily in two cases: 1) where a country requires local clinical experience for their population; or 2) where reimbursement institutions require separate clinical trials to address comparative questions not required for regulatory approval.

ISTA: Post-approval studies are based on the needs of our customers and the ophthalmic community and can vary from additional data points or head-to-head [comparison] with a major competitor.

EyeWorld: Once a drug is approved, how much control does the pharmaceutical company have over the cost to the patient?

Alcon: We work with payers on national levels to get our drugs reimbursed based on our clinical results.

EyeWorld: How often does the FDA need more data on a drug? Is there any way to predict that? Are you typically surprised when the FDA comes back requesting additional studies, or is it sometimes expected?

Alcon: We estimate that about 10% of submissions require additional data or studies, such as in the case of study replication or where the FDA has a difference between its perceived safety of the drug and the clinical data.

EyeWorld: If the FDA does need more data, how much does an additional trial cost?

Alcon: Additional trials range from $5-20 million.

EyeWorld: How do you decide whether or not to get the additional data?

Alcon: Two key factors that drive our decision are: 1) whether the additional data is required for approval or whether it is a post-approval commitment; and 2) where the product fits into the competitive landscape.

ISTA: If the FDA requires additional data, companies would need to figure whether the timing and costs fit within their strategic goals and the market needs. If you consider the timing from the initial trials to the completion of additional trials, market conditions and needs may be vastly different.

EyeWorld: Once a drug is in the hands of the FDA, what is the waiting process like for those involved? Is it incredibly stressful for months, or are you able to put it out of your mind and focus on other things?

Alcon: While we closely monitor the regulatory processes, most of our R&D associates are working on multiple projects concurrently, so while one product is awaiting approval, they shift their attention to another project or are preparing for launch activities.

ISTA: As with most companies, there are additional priorities occurring simultaneously. In order for companies to be successful, we want multiple projects in the pipeline; unfortunately, even with the best effort and millions of dollars invested, there are no guarantees for approval.

Editors' note: Dr. Krueger is head of portfolio and project management, Alcon. Mr. Chang is director of product marketing, ISTA Pharmaceuticals, and founding member, Vanguard Ophthalmology Society.

Contact information

Krueger: Dave Jackson at

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