From clinician to chief medical officer
Three ophthalmologists talk about their switch to CMO and what they have learned.
By Robert Stoneback, associate editor
The role of the chief medical officer (CMO) is to advise physicians and industry on how to best serve patients, and CMOs with clinician experience are best equipped to address these needs. We talked to three CMOs — Raj Rajpal, MD, of Avedro, Jai G. Parekh, MD, MBA, of Allergan, and Jonathan Talamo, MD, of Johnson & Johnson Vision — about how their time as physicians has influenced their jobs as CMOs. Dr. Rajpal practices at and is the founder of the See Clearly Vision Group, in the Maryland and Virginia area; Dr. Parekh is the founding partner of EyeCare Consultants of NJ, Woodland Park/Edison, and associate professor of ophthalmology/cornea service at the New York Eye and Ear Infirmary of Mt. Sinai; Dr. Talamo sold his Boston private practice in 2014 to devote himself full-time to his CMO position.
Q. How has your experience in practice helped you as CMO?
Raj Rajpal, MD: My experience allows me to better express the company’s perspective to my practicing colleagues. Staying in practice helps keep me current on issues facing both patients and ophthalmologists, giving me extra credibility with our customers. It also allows me to bring insights back to the company about what is working well and we can improve.
Jai Parekh, MD, MBA: Clinicians see me as someone who is still “in their shoes,” and that leads to a level of trust between the two parties. For our potential customers, interacting with someone who understands the reality of dealing with patients and procedures allows us to better discuss their unmet needs or desires with our products.
Jonathan Talamo, MD: It is critically important that medical device companies like mine have people in C-suite leadership roles who have directly served patients. My experience as a surgeon gives me insight into how both unmet needs, and industry solutions for those needs, will be perceived and adopted by patients and doctors. But all parties, whether industry, medical professionals or patients, want the same thing from our products — safety, efficacy and affordability.
Q. What have you learned about practices from your new industry perspective?
RR: One of the things I have learned is just how crucial communication is between clinicians and industry. At Avedro, we get a lot of feedback from physicians clearly telling us “these are our needs in our practice, these are the clinical results we are seeing,” and that helps us find the best way to add value to what these physicians are doing and what to offer their patients.
JP: While getting a product to market is its own set of challenges, what I see differently now is how practices attempt to incorporate these products. The value proposition of new devices and procedures can be hard for physicians — they are worried about income-generation and dwindling reimbursement, and sometimes their needs may not match a company’s. Allergan’s role is to continue providing value to customers and showing we value their success and ability to care for a range of patients.
JT: Until I got on the other side of the fence, I didn’t realize how important individual customer relationships are to companies. Those lines of communication keep things open, transparent and honest between industry and doctors. We rely on physician advisers in the field to say “this is the product we are looking for,” and we need scores of such advisers to give us the feedback we need on products.
Q. What would you want to tell practicing MDs they may not know about the industry side?
RR: Since becoming a CMO, I’ve learned how important the entire team is in bringing new innovations to clinicians. Besides all the effort it takes for FDA approval, there are significant resources needed for commercialization, to ultimately bring a product to market. Through this process, a CMO can help communicate with physicians and patients about the timelines and why some products may, at first, be only available outside the United States.
JP: When it comes to bringing new products to market, I think physicians don’t always know the investment needed for innovation and R&D. Sometimes development doesn’t go as planned or takes longer. Also, a company has to consider the needs of different customers and markets; that is true customer-centricity. Delays for these products are not due to lack of appreciation for customers and patients. We want the same thing as physicians — we just operate on a more complicated scale.
JT: The regulatory process is very different from country to country, with each market having its own unique requirements. Because of these regulations, a market may want a particular innovation or product, and despite our appetite for launching new innovations, we may not be able to bring all new product advances to every market. Ultimately, we try to do what’s best for each market, its healthcare providers and the patients we serve. OM
Study: Laser therapy the winner for glaucoma
SLT could soon be the go-to first-line treatment.
By René Luthe, senior editor
A three-year study published in the Lancet (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32213-X/fulltext ) demonstrated that selective laser trabeculoplasty (SLT) produces similar outcomes to prescription eyedrops and is more cost effective, leading investigators to conclude that SLT should replace eyedrops as the first-line treatment for glaucoma.
The investigators reached their game-changing conclusion after they examined findings from an observer-masked, randomized, multi-site, controlled trial in the United Kingdom of 718 treatment-naïve patients with open-angle glaucoma or ocular hypertension and no ocular comorbidities. Patients were randomly allocated to initial SLT or to prescription drops. The primary outcome was health-related quality of life (HRQoL) as measured by the EQ-5D at three years, with secondary outcome measures of cost and cost-effectiveness, disease-specific HRQoL as measured by the Glaucoma Utility Index (GUI), Glaucoma Symptom Scale (GSS) and Glaucoma Quality of Life-15 (GQL-15), clinical effectiveness and safety.
The average EQ-5D score was 0.89 in the SLT group vs. 0.90 in the eyedrops group, with no significant difference. At 36 months, 74.2% of the SLT patients required no drops to maintain IOP at target, and eyes of patients in this group were within target IOP at 93.0% of visits vs. 91.3% for the eyedrops group. None of the patients in the SLT group required further glaucoma surgery to lower IOP vs. 11 patients in the eyedrops group.
Along with finding no significant different in HRQoL and clinical outcomes, the study found “a 97% probability of SLT as first treatment being more cost-effective than eyedrops first at a willingness to pay of £20,000 per quality-adjusted life-year gained.”
The investigators claim SLT should save the UK’s National Health Service £1.5 million per year in treating the disease — a conclusion sure to interest third-party payers in the United States as well, particularly as baby boomers age. According to National Health Expenditure data, under current law, U.S. health spending is projected to grow faster than GDP per year over the 2018-2027 period. The health share of GDP is expected to rise from 17.9% in 2017 to 19.4% by 2027 (https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/nationalhealthexpenddata/nhe-fact-sheet.html ).
“This robust study with long-term follow up supports the use of SLT in the primary treatment of open-angle glaucoma and ocular hypertension,” says Brian A. Francis, MD, MS, professor of Ophthalmology, Rupert and Gertrude Stieger Endowed Chair in Vision Research at Doheny Eye Institute and Stein Eye Institute at UCLA’s David Geffen School of Medicine. He notes that the SLT group had more stable disease and better disease-specific symptom scores. “Importantly, the cost-effectiveness of the laser first treatment was proven with lower treatment costs,” Dr. Francis says. “These results suggest a paradigm shift supporting earlier laser trabeculoplasty treatment of open-angle glaucoma and high-risk ocular hypertension patients.”
Thomas M. Brunner, president and CEO of Glaucoma Research Foundation in San Francisco, notes that moving to SLT as first-line treatment would eliminate the glaucoma specialists’ age-old adversary — patient compliance.
“There is great interest in sustained-release drug delivery to help patients improve their adherence to use of medications,” he says. But, “SLT is a treatment done by the doctor with 100% compliance or adherence and no requirement for patients to fill a prescription or remember to take their eyedrops. Pressure is controlled 24/7 without depending on the patient.” OM
Kala announces STRIDE 1 and STRIDE 2 results
By Conni Bergmann Koury, contributing editor
Kala Pharmaceuticals announced results from its two Phase 3 clinical trials, STRIDE 1 and STRIDE 2 (Short Term Relief In Dry Eye), evaluating the safety and efficacy of KPI-121 0.25% versus placebo in patients with DED.
KPI-121 0.25% achieved statistical significance for the primary sign endpoint of conjunctival hyperemia in the intent to treat (ITT) population. KPI-121 0.25% also achieved statistical significance for the primary symptom endpoint of ocular discomfort severity at day 15 in the ITT population in STRIDE 1 with a trend toward a treatment effect in STRIDE 2. Statistical significance was achieved in STRIDE 1 for the second primary symptom endpoint of ocular discomfort severity at day 15 in patients with a more severe baseline discomfort, with a strong trend towards a treatment effect observed for the same endpoint in STRIDE 2.
Positive treatment effects were also observed in both trials for the symptom endpoint of ocular discomfort severity in the ITT population at day eight. KPI-121 0.25% was well-tolerated in all trials with elevation in IOP similar to placebo.
Also, a Phase 3 clinical trial STRIDE 3 is evaluating KPI-121 0.25% for the temporary relief of the signs and symptoms of DED. Kala believes that it has identified key factors that contributed to the differences observed in the results from STRIDE 2 compared to those of STRIDE 1 and the Phase 2 study.
KPI-121 0.25% utilizes Kala’s AMPPLIFY mucus-penetrating particle drug delivery technology. For more, see page 74.
EyePoint’s Dexycu (dexamethasone intraocular suspension) 9% is available in the United States. Dexycu is the only FDA-approved intraocular steroid to treat postoperative inflammation; it is a dropless treatment administered as a single dose at the end of cataract surgery.
Aerie announced FDA approval of Rocklatan 0.02%/0.005%, its netarsudil and latanoprost ophthalmic solution to reduce IOP in patients with open-angle glaucoma or ocular hypertension. Aerie plans to launch Rocklatan, a once-daily eyedrop, in the second quarter of 2019.
The Rapid SLT, Volk’s newest lens, provides four high-resolution views of the angle to enhance ease-of-use by minimizing the need for lens rotation, effectively reducing the SLT procedure time by half. The four views offered by the lens reduce the number of laser shots by 25%, increasing patient comfort.
Alcon acquired PowerVision, Inc., a privately-held, U.S.-based medical device company. PowerVision’s focus is fluid-based IOL implants; commercial availability of its IOL technology will be determined following additional development and clinical trials.
Aldeyra Therapeutics announced positive results from its Phase 3 ALLEVIATE trail of 0.25% and 0.5% reproxalap topical ophthalmic solution for patients with allergic conjunctivitis. The trial met the primary and secondary endpoints for both reproxalap concentrations.
Topcon’s recently unveiled Maestro Unlimited integrates the Maestro 3D OCT with the Topcon Harmony web-based data management application. Maestro Unlimited gives access to an automated OCT/fundus camera imaging system with a secure archive for exam data.
Bausch + Lomb began distribution of Lotemax SM 0.38% in the United States. Lotemax SM is a gel drop formulation of loteprednol etabonate for use with SubMicron (SM) technology for treatment of postoperative inflammation following ocular surgery.
Quantel Medical received FDA approval for its new ultrasound platform, the ABSolu. The ABSolu, which replaces Quantel’s flagship Aviso ultrasound system, has several new features, including a 70% increase in depth of field and higher image quality of the anterior chamber and lens.