Industry Insider is a timely chat with an ophthalmic industry thought leader.
David McMullin joined Aldeyra Therapeutics as senior vice president and head of corporate development and strategy in 2018 and was promoted to chief commercial officer in 2019. Aldeyra’s lead compound, topical ocular reproxalap, is in Phase 3 clinical trials for the treatment of allergic conjunctivitis and dry eye disease. A second investigational drug, ADX-2191, is scheduled to begin Phase 3 clinical trials in Q4 2019 for the prevention of proliferative vitreoretinopathy (PVR), a sight-threatening condition with no approved treatment.
Ophthalmology Management: Can you talk about your Phase 3 ALLEVIATE and RENEW trials, and what is next for reproxalap?
David McMullin: The ALLEVIATE results, which we shared at the AAO meeting, studied the effect of reproxalap in patients with allergic conjunctivitis. The primary endpoint for that test was improvement in the ocular itch score over the course of an hour vs. vehicle. We hit that endpoint and had a very low P value, less than 0.0001. Reproxalap also demonstrated a statistically significant key secondary endpoint, measuring a 2-point reduction in itch on a 0-4 scale, with a P value of 0.0005.
We’re thrilled with the ALLEVIATE results, as they show the efficacy of our drug and its superiority over vehicle. In the first half of 2020, we plan to initiate the INVIGORATE Phase 3 clinical trial of reproxalap in allergic conjunctivitis.
RENEW is an adaptive Phase 3 clinical trial investigating reproxalap’s effectiveness in improving the symptoms and signs of dry eye disease; RENEW Part 1 is scheduled to be completed by the end of 2019. We had very strong data from our Phase 2b clinical trial in dry eye disease last year showing statistically significant improvements in symptoms and signs, and we hope that RENEW will confirm those findings.
OM: Can you give us an update on the status of ADX-2191?
DM: We’re really excited to help bring to market this unique solution for PVR. PVR can manifest after retinal reattachment surgery, causing the surgery to fail and the retina to re-detach. Currently, the only treatment option is to have that surgery performed again. Repeat surgeries impact quality of life and result in vision loss. If approved, ADX-2191 would give patients a therapeutic option to achieve a successful reattachment surgery by keeping PVR at bay, enabling patients to retain their vision and avoid repeating the surgery.
We expect to initiate an adaptive Phase 3 clinical trial in PVR before the end of 2019 — the first indication in our retinal disease platform to begin clinical testing. In addition to orphan designation for PVR prevention, we have FDA fast track approval, as well.
OM: Your role is described as “implementing a commercial strategy for Aldeyra.” Can you explain this strategy?
DM: My job is to help Aldeyra, which became a public company 5 years ago, transition from a clinical development organization to one that is preparing for commercialization. Our first and foremost focus is on helping patients and physicians by bringing best-in-class treatment innovations to market that address unmet medical needs. We believe that this “patients first” approach is the right focus for benefiting all of our stakeholders.
OM: You have spent more than 20 years in the biopharmaceutical industry — what experience do you bring to your role at Aldeyra?
DM: During my career, I have launched seven therapeutics in the U.S. and globally, each requiring different strategies and tactics to be successful but all requiring significant organizational change and excellence in execution. At Aldeyra, we’re at a stage where we have to evolve, and so my experiences are directly applicable. The company we were in the past is not the company we need to be in the future, and my skillset is complementary to that transition. OM