Ophthalmology on a Roll: Key U.S. Market Events in May 2019

Contributors : Emma McFadden, PhD – Senior Director, CNS & Ophthalmology | Himanshu Jain, M.S. Pharm - Principal Analyst, CNS & Ophthalmology | Ruchita Kumar, PhD - Lead Analyst, CNS & Ophthalmology

Publish date: 28 May, 2019

New product launches, product acquisitions, and life-cycle management strategies for existing products (e.g., expansion into related indication) are common ways for a pharmaceutical organization to expand its footprint in any therapy area, including ophthalmology. Interestingly, in May 2019, the U.S. ophthalmology market witnessed important events encompassing these three strategies, as discussed below.

 

 

Key events in May 2019 in the U.S. ophthalmology market


  1. May 1, 2019: Aerie Pharmaceuticals launched Rocklatan for open-angle glaucoma / ocular hypertension

What does this launch mean for the treatment of glaucoma?

Rocklatan is the second glaucoma therapy launched by Aerie Pharmaceuticals in the U.S. market and follows the 2018 launch of Rhopressa (netarsudil 0.02%)—a Rho kinase inhibitor with a unique mechanism of action.1 Rocklatan is the first and only fixed-dose combination (FDC) in the United States containing the standard of care latanoprost 0.005%, which Aerie combined with Rhopressa to make this novel FDC. Perhaps encouraged by the FDC’s superiority in intraocular pressure (IOP) reduction over latanoprost or Rhopressa alone, as evident in its pivotal studies, the company is positioning Rocklatan as a first-line treatment option in glaucoma and have launched it at a premium price to Rhopressa.2,3 Additionally, Rocklatan is the only FDC, and one of only a few glaucoma drugs, that requires once-daily topical administration, whereas other FDCs are recommended for dosing two or three times per day (e.g., Allergan’s Combigan, Novartis’s Simbrinza).

Decision Resources Group’s (DRG) real-world data analysis indicates that glaucoma patients are often prescribed multiple eye drops to manage their condition and latanoprost is a preferred combination partner among patients receiving polypharmacy.4 Additionally, despite the availability of multiple generic glaucoma drugs, branded FDCs, such as Combigan, continue to have an important presence in this market because of the convenience offered by these agents when greater efficacy is necessitated. Rocklatan’s attractive product profile, as well as these findings, signify a distinct opportunity for Rocklatan in the highly competitive glaucoma space. However, Rocklatan’s uptake is likely to be constrained, at least initially, by market access challenges. Indeed, new glaucoma drugs face formidable obstacles to gaining favorable formulary coverage and placement, particularly on Medicare Part D plans, within the early period after launch, largely because of the preferential coverage of generic options.5 Nevertheless, Aerie Pharmaceuticals announced that they are working to strengthen formulary coverage of Rocklatan1 and we expect that it will be a welcome addition to the treatment armamentarium for glaucoma.

  1. May 9, 2019: Novartis signed a deal with Takeda to acquire Xiidra, a therapy for dry eye disease (DED)

What does this acquisition mean for the DED market and Novartis’s Ophthalmology portfolio?

The deal is expected to close in the second half of 2019, with Novartis’s paying an impressive $3.4 billion in upfront payment and up to $1.9 billion in potential milestone payments for Xiidra, which clocked only $400 million in net sales in 2018.6 According to Novartis, key factors that contributed to the company’s decision to acquire Xiidra include a large and growing prevalent pool of DED in the United States, Xiidra being the only approved therapy for treating both the signs and symptoms of DED in the United States, and the potential launch of Xiidra in other markets (e.g., in Europe, where it is in preregistration phase for DED).6,7 Of note, Xiidra’s competitor in DED—Allergan’s Restasis—had blockbuster sales in 20188 and the U.S. and EU5 DED markets have limited current competition. One of the key reason why Xiidra has struggled since its launch in 2016 in the U.S. DED market, despite offering some advantages over Restasis, is its lack of formulary coverage in the majority of Medicare prescription drug plans.5 Moreover, utilization-management restrictions, such as prior authorization / step-therapy rules and quantity limits, for Xiidra are common in many commercial plans. With the expected availability of generic versions for Restasis in the U.S. market in 20199 and a large late-phase pipeline for DED, with many emerging therapies targeting key unmet needs in this indication,10 recovering the acquisition cost for Xiidra will be an uphill task for Novartis. Nevertheless, we expect that with Novartis’s commitment to its Ophthalmology portfolio and expertise in this space, Xiidra’s position in the market will be strengthened and the pool of Xiidra-treated DED patients will expand. Additionally, Xiidra will help bolster Novartis’s mature front-of-the-eye business.

  1. May 13, 2019: Regeneron received FDA approval for Eylea in diabetic retinopathy (DR)

What does this approval mean for the brand and for the treatment of DR?

With Eylea’s recent label expansion for the treatment of all forms of DR in the United States, it becomes the second product after Roche / Genentech’s Lucentis (0.3 mg) to receive approval for this indication and broadens the DR patient population who are eligible for Eylea, having been approved in 2015 for the treatment of DR in patients with diabetic macular edema (DME). Eylea’s most-recent approval was based on the encouraging findings from the company-sponsored Phase III PANORAMA trial in patients with moderately severe to severe nonproliferative DR (NPDR) patients without DME; after one year of treatment, patients receiving Eylea (every eight weeks or every sixteen weeks after more-frequent initial dosing) demonstrated a much lower risk (85%-88%) of developing proliferative DR (PDR, including anterior segment neovascularization), compared with sham-treated patients. Additionally, the majority of Eylea-treated patients (65-80%) experienced improvement in their DR severity at one year.11

Although a growing body of clinical evidence supports the utility of intravitreal VEGF inhibitors in reducing the risk of disease progression and vision impairment in DR patients without DME, various factors restrict the use of VEGF inhibitors in these patients. These factors include a lack of timely diagnosis of the disease, competition from the standard of care panretinal photocoagulation in PDR, and a lack of physicians’ and patients’ inclination towards initiating intravitreal anti-VEGF agents earlier in the disease (i.e., before developing vision-impairing DME).12 Nevertheless, we expect that Eylea will be able to carve out a niche in this segment because it is the first-to-market therapy having demonstrated efficacy in moderately severe to severe NPDR patients without DME (when dosed every eight or sixteen weeks) and has a flexible and less-frequent dosing schedule than Lucentis (after an initial monthly dosing period), which is an advantage for physicians and patients. Moreover, Eylea’s established position in the DME space and Regeneron’s commitment to the brand will likely boost its acceptance further in DR without DME.13

Given that Eylea is a key revenue-generating product for Regeneron (with net sales of approximately $4 billion in 2018),14 the company continues to work on different strategies to maximize opportunities for Eylea. These strategies include indication expansion (Phase III planned in retinopathy of prematurity), the development of a prefilled syringe formulation, and the development of a higher dose formulation.15 We expect that Regeneron’s commitment to the Eylea brand, its robust product profile, and these strategies will help insulate the brand from competition on the horizon in the United States, including from Novartis’s brolucizumab, which is expected to launch for wet AMD in 201916 and DME in 2021,13 Allergan’s abicipar pegol, which is expected to launch for wet AMD in 2020,16 and the anticipated entry of aflibercept biosimilars in 2023.

May 2019 has been an active month so far for ophthalmology in the United States and recent market events highlight key strategies that pharmaceutical companies can use to expand their presence in this space. Indeed, opportunities within the ophthalmology market are substantial and it is an area of strategic interest and high commercial importance for many pharmaceutical companies. In terms of commercial importance, key disorders in this area include retinal disorders (e.g., wet AMD, DME / DR), glaucoma, and corneal and external eye diseases (e.g., dry eye disease). DRG will continue to track key trends and market dynamics in ophthalmology indications across our syndicated product offerings in 2019.17

DRG’s Recent and Upcoming Product Offerings in Glaucoma, Dry Eye Disease, and Diabetic Retinopathy / Diabetic Macular Edema

  • DRG’s Glaucoma | Current Treatment | Detailed, Expanded Analysis - Treatment Algorithms - Claims Data Analysis (US), May 2019.
  • DRG’s Glaucoma | Access & Reimbursement | Detailed, Expanded Analysis (US), publishing in August 2019.
  • DRG’s Dry Eye | Unmet Need | Detailed, Expanded Analysis (US/EU5), May 2019.
  • DRG’s Diabetic Macular Edema | Current Treatment | Detailed, Expanded Analysis - Treatment Algorithms - Claims Data Analysis (US), January 2019.
  • DRG’s Diabetic Maular Edema / Diabetic Retinopathy | Disease Landscape & Forecast (G7), December 2018.
  • DRG’s Report – Special Focus on Retinal Therapies | Access & Reimbursement | Detailed, Expanded Analysis (US), publishing in December 2019.

References:

  1. Aerie Pharmaceuticals, news release, May 1, 2019.
  2. Aerie Pharmaceuticals, corporate presentation, May 14, 2019.
  3. Red Book database, accessed May 17, 2019.
  4. DRG’s Glaucoma | Current Treatment | Detailed, Expanded Analysis - Treatment Algorithms - Claims Data Analysis (US), May 2019.
  5. DRG’s Fingertip Formulary databases, accessed May 17, 2019.
  6. Novartis, media release and investor presentation, May 9, 2019.
  7. European Medicines Agency, applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use, January 2019.
  8. Allergan, form 10-k, 2018, accessed May 17, 2019.
  9. Allergan, Q1 2019 earnings presentation, May 7, 2019.
  10. DRG’s Dry Eye | Unmet Need | Detailed, Expanded Analysis (US/EU5), May 2019.
  11. Regeneron, press release, May 13, 2019.
  12. What Are the Opportunities and Challenges to Drug Development for Diabetic Retinopathy? Blog published in December 2018.
  13. DRG’s Diabetic Macular Edema / Diabetic Retinopathy | Disease Landscape & Forecast | G7, December 2018.
  14. Regeneron’s Q4 2018 Financial Results, February 6, 2019.
  15. Regeneron Corporate Presentation, May 2019.
  16. DRG’s Age-Related Macular Degeneration | Disease Landscape and Forecast | G7, publishing in October 2019.
  17. DRG’s Biopharma Reports in Ophthalmology.

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