Raymond Douglas, MD, PhD, serves as global head, scientific affairs, for RVL Pharmaceuticals, headquartered in Bridgewater, N.J. RVL’s premier therapy is Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1%, a prescription eyedrop for the treatment of acquired ptosis in adults (also known as acquired blepharoptosis or droopy eyelid). Dr. Douglas has previously been involved with the development of TEPEZZA (teprotumumab-trbw, Horizon Therapeutics), the first drug approved by the FDA for the treatment of thyroid eye disease.
Ophthalmology Management: Upneeq is the first FDA-approved eyedrop to treat acquired ptosis in adults. What is the significance of this for patients and physicians?
Raymond Douglas: Upneeq provides relief for patients with acquired ptosis — especially for mild or moderate cases — without the need for surgery, which prior to this treatment was the only option available. Ophthalmologists can now treat this condition themselves instead of referring patients to an oculoplastic surgeon.
Two of the guiding factors in the introduction of Upneeq was how satisfied patients have been and how under-recognized ptosis is. Much of our development has focused on recognizing acquired ptosis, especially mild and moderate forms, and offering treatment that improves both the ability to open the eyelid and the appearance of the eyelid.
OM: How does the eyedrop work?
RD: The drop stimulates the Müller’s muscle in the eyelid — which is one of two muscles that elevate the eyelid. The drop is specific for the receptors on this muscle (alpha adrenergic receptors) and causes contraction of the muscle for approximately 6-8 hours. By doing so it lifts the eyelid.
By elevating the eyelid, field of vision is improved as well as appearance. As a result, many patients have experienced improved function, as well as feeling more awake and comfortable. We are conducting studies that examine both elements, which are important to patients.
We’ve been really struck by how enthusiastic patients have been.
OM: Upneeq is the only non-surgical treatment option for acquired ptosis. As an oculoplastic surgeon, why get involved with a company/product that could potentially deter or even replace business?
RD: This product represents a new paradigm for patients — I don’t view it as replacing my surgical technique, but as an adjunct treatment. Some patients may not even know they have ptosis and are just learning about this condition and may not be ready for surgery. This gives me the opportunity to explain the process to them and introduce a treatment that will improve their daily life, without having to resort to surgery. Most patients are happy to start with the drop.
However, those patients with more severe conditions who experience insufficient muscle function, or the ptosis is too severe to be improved or indicated for use of the drop, will still need surgery.
OM: You previously worked on developing TEPEZZA. Can you share some of the similarities between that drug and Upneeq?
RD: Upneeq and TEPEZZA fulfill an unmet need in that they present a non-surgical option for patients. This really helped solve a patient pain point that we didn’t realize was there. Now we can diagnose patients with ptosis and thyroid eye disease, and we can see them much more readily because we have these treatments available. And that helps with patient outcomes.
Another parallel between the two treatments is that, like TEPEZZA, Upneeq is well-tolerated over time. The drop also has a low side-effect rate — which has been one of the most pleasing aspects of our studies.
OM: What other developments are in the pipeline at RVL?
RD: We seek to selectively acquire or in-license approved products and late-stage product candidates that complement our existing product portfolio, technology or commercial infrastructure. OM